Sr Manager, Quality Assurance

The Sr. Manager of External Quality Operations leads a team of QA personnel responsible for managing the quality interface with manufacturing and testing partners for clinical small and large molecules, early to late phase for API / Drug Substance / bulk drug products / drug products and finished products. This person will be responsible for managing a team responsible for onboarding of new clinical assets, product / process transfer, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management. This person will lead continuous improvement initiatives related to Biogen’s QMS and procedures for CMO and partner oversight.

This position collaborates with internal and external functions such as External Manufacturing Operations, Clinical Supply Chain, Label Development, Planning & Logistics, Regulatory Affairs, Product Development Quality and Technical Development to ensure compliance with cGMP regulations and Biogen QMS.

Success in the role requires a strong knowledge in the application of phase appropriate, risk-based quality principles to multiple modalities of product ie. Solid dosage forms, parenteral, gene therapies etc. Success in this role also requires an ability to develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.

Responsibilities
•Manage the External Quality Operations Team, including personnel performance and development, adherence to operation budgets and establishing team goals and priorities aligned with PO& T and companywide objectives.
•Ensure efficient and effective use of team resources to support priorities and drive for results.
•Oversee quality aspects of GMP activities for clinical product manufactured, stored, and distributed, through Biogen’s CMO and investigator site network. Activities include product disposition, quality support manufacturing operations, exceptions management, change control, risk management, technology transfer and validation.
•Provide Quality expertise to influence decisions across the Biogen Supply Chain.
•Establish and improve systems/processes in Global Quality with a goal of compliance, efficiency and standardization.
•Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections.
•Regularly benchmark current industry Quality standards related to modality specific GMP activities and publish current results with action items.
•Perform functions and makes decision consistent with cGMPs, GDPs and Biogen's quality governance
•Draft and negotiate Quality Agreements with CMO’s
•Collect and perform trend analysis for KPIs.
•Lead Site Quality Management Review Meetings
•Additional duties as assigned.

•Minimum of 8 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 5 years in clinical and or commercial quality operations.
•Minimum 3 years’ experience in managing or leading a team of three or more with success in

The Sr. Manager of External Quality Operations leads a team of QA personnel responsible for managing the quality interface with manufacturing and testing partners for clinical small and large molecules, early to late phase for API / Drug Substance / bulk drug products / drug products and finished products. This role could be based in Cambridge, MA or RTP, NC.