Director, Product Quality Lead

Your mission

Director, Product Quality Lead

Pierre Fabre, the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.  

Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology. 

Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with "New Ways to Care."  

Join Pierre Fabre USA to make a real impact in people's lives. Your purposeful career begins here. 

SUMMARY: 

The Director, Product Quality Lead serves as the quality expert for PF cell therapy product programs and is responsible for making strategic quality decisions throughout the product lifecycle end-to-end.  The incumbent provides direction and alignment across different functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality.

ESSENTIAL FUNCTIONS:

• Defines stability program/strategy including product shelf life; Designs stability studies.  Supports Stability Manager with stability execution through review and approval of stability protocols and reports.
• Defines specification program/strategy.  Supports specification development through review and approval of Quality By Design and justification of specifications
• Supporting product metrics and signals (e.g. process monitoring /stability, etc.) and initiates / supports improvement projects to enhance performance and /or mitigate quality or compliance risks across development portfolio.
• Works in partnership with PF and partner product development functions to ensure there are established overall Product Quality Profiles and implementation of QbD principles.
• Leads and/or supports investigations (as necessary) in response to quality signals / complaint trends or critical deviations. Actively gathers necessary SME’s (e.g. Technical/Regulatory) and leads team to resolve.
• In collaboration with PF Technical Operations and partners, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations.
• Supports and enables strategic management of Quality Risk Management (QRM) for assigned products.
• Supports and/or leads complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities.
• Quality approver of key strategic product documents (e.g. Specifications, Stability Plans, Process descriptions, QbD documents, Process Development plans).
• Ensures holistic quality reviews are performed and standards established for regulatory filings, inspections and compliance audits.
• Acts as the lead Quality input to ensure the product teams are fully aligned around the Quality Strategy.
• Represents Product Quality in CMC Team, Program Team, and business partner meetings to provide strategic direction and leadership to product development, registration, and approvals.
• Represents product quality in meetings with regulatory agencies and supports regulatory inspections.
• Owns the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions are managed to conclusion.
• Interfaces with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings.
• Other duties, as assigned.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a related field (e.g., Quality Management, Engineering, Life Sciences).
• Minimum of 7-10 years of experience in strategic quality management of cell and gene therapy programs.
• Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for ATMP products.
• Strong knowledge with regulatory standards (e.g., ISO, FDA, GMP, EMA).
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills.
• Proficiency in quality management software and tools.
• Certification in Quality Management (e.g., ASQ, Six Sigma) is a plus.

WORK ENVIRONMENT:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

LOCATION: Remote.  Some travel (10-15%) to NJ office as needed

Benefits of being a Pierre Fabre Employee 

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees. 

Pierre Fabre   

Pierre Fabre has been recognized by Forbes as one of the "World's Best Employers" for the 3rd year running. 

https://www.pierre-fabre.com/en-us 

True to My Nature 

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.