Senior Quality/GxP Auditor - 5004
Posted on Sep 25, 2024 by Verista
Columbus, OH
Accountancy
Immediate Start
Annual Salary
Full-Time
Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior Quality/GxP Auditor Responsibilities:
Develop and present Compliance plans and strategies based on client requirements.
Actively consult clients on industry best practices and regulations.
Provide mentorship and training to lesser experienced team members.
Support inspection readiness audits and large-scale remediation efforts.
Act as subject matter expert in all areas of Quality & Compliance.
Guide and ensure client compliance with industry best practices and regulations.
Review GxP auditing projects for correct approach, consistency, and quality; and identify and incorporate opportunities for improvement.
Provide coaching and/or training to company peers on quality-related matters and audit execution
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization.
Ability to mentor and guide lesser experienced team members.
Ability to communicate effectively with clients.
Proven ability to identify areas of business expansion and report to the management team for follow-up.
Intermediate Microsoft Project capabilities.
Requirements
Must be willing to travel to potentially multiple client sites including Columbus, OH
Demonstrated delivery of Quality Lead level requirements.
Demonstrated capability to deliver on the Senior Quality Lead Responsibilities.
Demonstrated expert knowledge of GxP regulatory requirements and industry best practices.
Capable of delivering industry lectures and training on applicable experiences.
Capable of identifying, proposing, and selling services to clients
10+ years of independently leading NDA submission process
Proven experience in preparing Integrated Summary of Effectiveness (ISE) to gain indication approval for applications covered by section 505(b)(2) and leading clients on most efficient & compliant pathway.
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Ability to mentor and guide less experienced team members
Ability to communicate effectively with clients
Proven ability to identify areas of business expansion and report to management team for follow-up
Ability to work independently and as part of a team, with the ability to transition between the two
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $216,397
*Verista is an equal opportunity employer.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior Quality/GxP Auditor Responsibilities:
Develop and present Compliance plans and strategies based on client requirements.
Actively consult clients on industry best practices and regulations.
Provide mentorship and training to lesser experienced team members.
Support inspection readiness audits and large-scale remediation efforts.
Act as subject matter expert in all areas of Quality & Compliance.
Guide and ensure client compliance with industry best practices and regulations.
Review GxP auditing projects for correct approach, consistency, and quality; and identify and incorporate opportunities for improvement.
Provide coaching and/or training to company peers on quality-related matters and audit execution
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization.
Ability to mentor and guide lesser experienced team members.
Ability to communicate effectively with clients.
Proven ability to identify areas of business expansion and report to the management team for follow-up.
Intermediate Microsoft Project capabilities.
Requirements
Must be willing to travel to potentially multiple client sites including Columbus, OH
Demonstrated delivery of Quality Lead level requirements.
Demonstrated capability to deliver on the Senior Quality Lead Responsibilities.
Demonstrated expert knowledge of GxP regulatory requirements and industry best practices.
Capable of delivering industry lectures and training on applicable experiences.
Capable of identifying, proposing, and selling services to clients
10+ years of independently leading NDA submission process
Proven experience in preparing Integrated Summary of Effectiveness (ISE) to gain indication approval for applications covered by section 505(b)(2) and leading clients on most efficient & compliant pathway.
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Ability to mentor and guide less experienced team members
Ability to communicate effectively with clients
Proven ability to identify areas of business expansion and report to management team for follow-up
Ability to work independently and as part of a team, with the ability to transition between the two
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $216,397
*Verista is an equal opportunity employer.
Reference: 202387533
https://jobs.careeraddict.com/post/95564002
Senior Quality/GxP Auditor - 5004
Posted on Sep 25, 2024 by Verista
Columbus, OH
Accountancy
Immediate Start
Annual Salary
Full-Time
Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior Quality/GxP Auditor Responsibilities:
Develop and present Compliance plans and strategies based on client requirements.
Actively consult clients on industry best practices and regulations.
Provide mentorship and training to lesser experienced team members.
Support inspection readiness audits and large-scale remediation efforts.
Act as subject matter expert in all areas of Quality & Compliance.
Guide and ensure client compliance with industry best practices and regulations.
Review GxP auditing projects for correct approach, consistency, and quality; and identify and incorporate opportunities for improvement.
Provide coaching and/or training to company peers on quality-related matters and audit execution
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization.
Ability to mentor and guide lesser experienced team members.
Ability to communicate effectively with clients.
Proven ability to identify areas of business expansion and report to the management team for follow-up.
Intermediate Microsoft Project capabilities.
Requirements
Must be willing to travel to potentially multiple client sites including Columbus, OH
Demonstrated delivery of Quality Lead level requirements.
Demonstrated capability to deliver on the Senior Quality Lead Responsibilities.
Demonstrated expert knowledge of GxP regulatory requirements and industry best practices.
Capable of delivering industry lectures and training on applicable experiences.
Capable of identifying, proposing, and selling services to clients
10+ years of independently leading NDA submission process
Proven experience in preparing Integrated Summary of Effectiveness (ISE) to gain indication approval for applications covered by section 505(b)(2) and leading clients on most efficient & compliant pathway.
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Ability to mentor and guide less experienced team members
Ability to communicate effectively with clients
Proven ability to identify areas of business expansion and report to management team for follow-up
Ability to work independently and as part of a team, with the ability to transition between the two
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $216,397
*Verista is an equal opportunity employer.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior Quality/GxP Auditor Responsibilities:
Develop and present Compliance plans and strategies based on client requirements.
Actively consult clients on industry best practices and regulations.
Provide mentorship and training to lesser experienced team members.
Support inspection readiness audits and large-scale remediation efforts.
Act as subject matter expert in all areas of Quality & Compliance.
Guide and ensure client compliance with industry best practices and regulations.
Review GxP auditing projects for correct approach, consistency, and quality; and identify and incorporate opportunities for improvement.
Provide coaching and/or training to company peers on quality-related matters and audit execution
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization.
Ability to mentor and guide lesser experienced team members.
Ability to communicate effectively with clients.
Proven ability to identify areas of business expansion and report to the management team for follow-up.
Intermediate Microsoft Project capabilities.
Requirements
Must be willing to travel to potentially multiple client sites including Columbus, OH
Demonstrated delivery of Quality Lead level requirements.
Demonstrated capability to deliver on the Senior Quality Lead Responsibilities.
Demonstrated expert knowledge of GxP regulatory requirements and industry best practices.
Capable of delivering industry lectures and training on applicable experiences.
Capable of identifying, proposing, and selling services to clients
10+ years of independently leading NDA submission process
Proven experience in preparing Integrated Summary of Effectiveness (ISE) to gain indication approval for applications covered by section 505(b)(2) and leading clients on most efficient & compliant pathway.
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Ability to mentor and guide less experienced team members
Ability to communicate effectively with clients
Proven ability to identify areas of business expansion and report to management team for follow-up
Ability to work independently and as part of a team, with the ability to transition between the two
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$87,780 - $216,397
*Verista is an equal opportunity employer.
Reference: 202387533
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