Manager, Quality Compliance
Posted on Sep 28, 2024 by Insmed Incorporated
Bridgewater, NJ
Human Resources
Immediate Start
Annual Salary
Full-Time
Company Description:
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Named Science’s Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview:
Manager, Quality Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed GMP Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development GMP activities.
Responsibilities:
Responsibilities:Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection back room lead.
Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
Perform internal audits
Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Quality Manual and Quality Policy, etc.
Responsible for the monthly metrics and management review
Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
Lead Insmed Quality Intelligence team for regulation changes
Support key investigations
Lead process improvement projects
Other duties as assigned
Qualifications:BS degree in Chemistry, Engineering, Life Science or related discipline required.
A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
Auditing experience required
Direct Global Quality experience preferred.
Must have had Health Authority inspection experience.
Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
Experience with internal and external audits.
ASQ CQE and CQA Certification preferred.
Must be able to partner and collaborate well cross functionally, at all levels.
Must have excellent communication and influence skills (verbal and written).
Should demonstrate the ability to manage projects and variable workloads.
Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.
Domestic and/or International travel required (upto15 %)#LI-JT1
Travel Requirements:
up to 15%
Salary Range:
$111,000 - $156,133 a year
Compensation & Benefits:
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid vacation schedule and winter break
ADDITIONAL U.S. BENEFITS:
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters
Additional Information:
Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Named Science’s Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview:
Manager, Quality Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed GMP Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development GMP activities.
Responsibilities:
Responsibilities:Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection back room lead.
Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
Perform internal audits
Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Quality Manual and Quality Policy, etc.
Responsible for the monthly metrics and management review
Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
Lead Insmed Quality Intelligence team for regulation changes
Support key investigations
Lead process improvement projects
Other duties as assigned
Qualifications:BS degree in Chemistry, Engineering, Life Science or related discipline required.
A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
Auditing experience required
Direct Global Quality experience preferred.
Must have had Health Authority inspection experience.
Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
Experience with internal and external audits.
ASQ CQE and CQA Certification preferred.
Must be able to partner and collaborate well cross functionally, at all levels.
Must have excellent communication and influence skills (verbal and written).
Should demonstrate the ability to manage projects and variable workloads.
Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.
Domestic and/or International travel required (upto15 %)#LI-JT1
Travel Requirements:
up to 15%
Salary Range:
$111,000 - $156,133 a year
Compensation & Benefits:
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid vacation schedule and winter break
ADDITIONAL U.S. BENEFITS:
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters
Additional Information:
Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Reference: 202647150
https://jobs.careeraddict.com/post/95647167
Manager, Quality Compliance
Posted on Sep 28, 2024 by Insmed Incorporated
Bridgewater, NJ
Human Resources
Immediate Start
Annual Salary
Full-Time
Company Description:
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Named Science’s Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview:
Manager, Quality Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed GMP Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development GMP activities.
Responsibilities:
Responsibilities:Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection back room lead.
Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
Perform internal audits
Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Quality Manual and Quality Policy, etc.
Responsible for the monthly metrics and management review
Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
Lead Insmed Quality Intelligence team for regulation changes
Support key investigations
Lead process improvement projects
Other duties as assigned
Qualifications:BS degree in Chemistry, Engineering, Life Science or related discipline required.
A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
Auditing experience required
Direct Global Quality experience preferred.
Must have had Health Authority inspection experience.
Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
Experience with internal and external audits.
ASQ CQE and CQA Certification preferred.
Must be able to partner and collaborate well cross functionally, at all levels.
Must have excellent communication and influence skills (verbal and written).
Should demonstrate the ability to manage projects and variable workloads.
Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.
Domestic and/or International travel required (upto15 %)#LI-JT1
Travel Requirements:
up to 15%
Salary Range:
$111,000 - $156,133 a year
Compensation & Benefits:
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid vacation schedule and winter break
ADDITIONAL U.S. BENEFITS:
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters
Additional Information:
Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Named Science’s Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview:
Manager, Quality Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed GMP Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development GMP activities.
Responsibilities:
Responsibilities:Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection back room lead.
Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
Perform internal audits
Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Quality Manual and Quality Policy, etc.
Responsible for the monthly metrics and management review
Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
Lead Insmed Quality Intelligence team for regulation changes
Support key investigations
Lead process improvement projects
Other duties as assigned
Qualifications:BS degree in Chemistry, Engineering, Life Science or related discipline required.
A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
Auditing experience required
Direct Global Quality experience preferred.
Must have had Health Authority inspection experience.
Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
Experience with internal and external audits.
ASQ CQE and CQA Certification preferred.
Must be able to partner and collaborate well cross functionally, at all levels.
Must have excellent communication and influence skills (verbal and written).
Should demonstrate the ability to manage projects and variable workloads.
Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.
Domestic and/or International travel required (upto15 %)#LI-JT1
Travel Requirements:
up to 15%
Salary Range:
$111,000 - $156,133 a year
Compensation & Benefits:
We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid vacation schedule and winter break
ADDITIONAL U.S. BENEFITS:
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters
Additional Information:
Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Reference: 202647150
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