Associate Director, External Quality Operations
10 hours ago
Pierre Fabre Pharmaceuticals is seeking an experienced Associate Director, External Quality Operations to join our team. As a key member of our Quality Operations department, you will be responsible for ensuring the highest standards of quality and compliance across all aspects of our operations.
Key Responsibilities:- Provide direct support to Contract Manufacturing Organizations (CMOs) from a quality and compliance perspective.
- Coordinate oversight of all quality interactions with CMOs and serve as the quality representative in internal core team meetings and joint meetings with CMOs.
- Ensure cGMP documents and records meet expectations for PFP review and approval in accordance with PFP procedures and applicable regulatory requirements.
- Bachelor's degree and 8-12 years of related pharmaceutical/biopharmaceutical work experience or master's degree and 6-8 years of work experience.
- Minimum of 5 years in management/leadership positions in a cGMP environment.
- Aseptic processing experience is required.
- Experience in commercial manufacturing required.
- In-depth working knowledge of cGMP Quality Systems.
- Demonstrated ability to manage cross-functional teams and inspire collaboration across the business.
- Preferred experience in cell and/or gene therapy operations and contract manufacturing.
Hybrid - Secaucus, NJ; Remote option will be considered with some travel (15%) to NJ office as needed.
Benefits:Pierre Fabre offers 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.
Pierre Fabre has been recognized by Forbes as one of the "World's Best Employers" for the 3rd year running.
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