The Quality Assurance Parental Fill (PF) Line 1 Manager is responsible for coordinating, managing and effective on the floor Quality Oversight within commercial Drug Product operations to ensure sustained compliance with GMPs and regulatory readiness.
The QA Manager's responsibilities include but are not limited to:
Management of QA Team and Departmental Projects, handling PF deviations, coordinating and conducting review of batch documentation, assisting in the development and implementation of Global Quality Systems, interfacing with Quality and Manufacturing customers, and review GMP documents and raw data for compliance with applicable procedures and regulatory and corporate guidance, and providing material acceptance decisions for production batches at the Biogen Research Triangle Park (RTP) PF Facility. The QA PF Line 1 Manager will also support internal compliance audits, due-diligence visits by partners and regulatory inspections.
The QA Manager must effectively work with Site QA operational functions for routine work and problem solving. The QA Manager has frequent interaction with internal Management including but not limited to Manufacturing, Engineering, Quality Control, Materials Management, Technical Development and Manufacturing Sciences.
QA Manager will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture and testing.
QA Manager is responsible for communicating and coordinating activities with key Quality Assurance customers, as appropriate, to support departmental, site, and global initiatives.
QA Manager will have cross-departmental interaction with peers to ensure timely communication of issues, support Quality and Manufacturing initiatives, and maintain harmonization of procedures, as appropriate.
Additional responsibilities include evaluation, scheduling, and balancing of departmental workload with respect to assignments/responsibilities/personnel, interviewing, hiring, training, and mentoring of subordinate employees, management of key departmental milestone projects.
Minimum Bachelor of Science or Engineering with a focus on Biotechnology, Biology, Chemistry, Process Engineering, or successfully obtain similar years of experience
Minimum 7 years technical and management experience in a regulated environment including at least 5 years of direct experience in Fill and Finish operations.; or a Master of Business Administration or Master of Science Degree (MBA/MS) with 8-10 years technical and management experience
All your information will be kept confidential according to EEO guidelines.