Director, Quality, Validation Engineering.US-HDQ.002

Posted on Aug 4, 2022 by Integra LifeSciences

Princeton, NJ
Research
Immediate Start
Annual Salary
Full-Time
Overview:



Responsibilities:



Directs, coordinates, and evaluates the activities of employees in the Quality Validation Department.  Required to lead, evaluate, document, and facilitate the development, execution and monitoring of validation strategies that ensure the predictable manufacture and distribution of medical products in compliance with corporate policies. Responsible for leading a global team of validation and standardizing global validation processes that are compliant to all regulations in which product is commercialized.  This position will support manufacturing operations, product development, and manufacturing transfers.   Must have the knowledge and experience necessary to support external audits for both animal and AATB requirements. 



 



Responsible for project/program management of all validation engineering processes needed to support new product, new materials, new equipment, and new process introductions. 



Directly supervises employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.



Builds high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation and execution of CAPAs, continuous improvement initiatives, and other quality initiatives



Provides strategic direction and communication of the company’s goals, directives, and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability.



Oversees validation in all manufacturing sites and drives standardization & consistency across the organization.



Ensure dependable and timely results from tests and support for process changes in compliance with QSR, ISO, AATB and other regulatory requirements.



Ensure and improve product reliability through proven quality science.



Oversee product quality reviews, divisional management reviews and preparation of quality reports as applicable for various forums, Divisional Board Review (DBR), Plant Operational reviews etc.



Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR and JPAL.



Ensures site compliance and readiness.  Oversees external regulatory inspections, timely follow up and closure of Regulatory commitments.



Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.



Ensure that all projects and validations are in compliance with QSR, ISO and other regulatory requirements.



Participate in evaluation of new product opportunities (introductions, enhancements, obsolescence). 



Lead in the develop and execution of engineering studies & validation protocols (IQ/OQ/PQ) for new equipment / processes / cleaning validations, as well as for periodic re-validations of existing equipment / processes and utilities to include (but not limited to) Lyophilizers, Autoclaves, CCA, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, ISO 5,7, and 8 cleanrooms, controlled temperature units, and lab equipment.



Responsible for cleaning validation, process qualification, packaging validation, test method qualification as well as any other validation deemed necessary to support base business, transfers, and NPI.



Aligns and connects program goals and milestones



Responsible for managing validation responsibilities in the generation and execution of Factory Acceptance Tests, qualification studies, manufacturing Standard Operating Procedures, risk analysis, and quality plans, in accordance with ISO and cGMP requirements.



Works with senior management to achieve alignment of Team and functions and ensure proper resourcing



Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.



Assures that the Project Team achieves established objectives



Provides a balanced appraisal of the program status, risk, and reward to stakeholders; acts as a single point of contact for the assigned project/projects



Coordinates compilation of validation program scope documents and plans



Develops the performance goals of the Project Team and provide input into performance evaluation of the individual team members



Ensures all decisions made at the Project Team level are assessed as to their impact - positive, negative or neutral on the current plan, budget and available resources



Communicates to peers, management and senior management as needed to ensure understanding, efficiency and alignment of program strategy



Use project management tools to lead validation strategies for large-scale and/or strategic Operations projects.



Develop and utilize a tracking system to facilitate prompt approvals of documents.



Motivate, Mentor, and manage a high performing team of a validation engineers to achieve department goals.



Work on project teams with other internal departments, external vendors, and customers as required.



Perform other related duties as expected. 



Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.



Bachelor’s degree in Engineering discipline or equivalent (Mechanical, Biotech, Chemical, etc.)



Master’s degree is preferred



Min 15-years’ experience in validation/manufacturing engineering/project management in engineering and manufacturing environments for medical device or pharmaceutical industry



At least 7 years of people management experience.



Demonstrated knowledge of FDA QSR regulations, ISO 13485, CMDR, EUMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.



Experience with tissue products and associated regulations



Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education



In-depth knowledge of validation, change control and manufacturing



Demonstrated organizational, management and communication skills.



Successful track record of project management, use of project management tools, and team management techniques



Must be proficient with statistical analysis, statistical analysis tools



Must be able to prioritize and manage multiple projects/programs at the same time



Capable of leading cross-functional teams



Ability to work independently and proactively in conjunction with all levels of the organization, including presenting to senior level management



Ability to travel up to 30% or more if needed based on site needs.



In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.


Reference: 75547906

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