Sr. Manager, Quality Assurance Biologics Manufacturing

Job Description

About this role 
The Quality Assurance Sr Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for large volume manufacturing providing operational oversight of batch production activities and evaluation, as well as providing batch acceptance decisions for production batches at the Biogen Research Triangle Park (RTP) facilities. This includes direct management of personnel performing routine QA coordination and oversight between Biogen facilities.  

What You’ll Do 

• Ensures Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.  
• Directs, leads, coordinates, and supports the activities of QA personnel to ensure that all activities are focused upon high productivity and the utmost technical integrity. Provides mentorship and training within and across functions.  
• Oversees and leads the QA team to provide quality/compliance support and expert guidance to manufacturing operations.  
• Assists QA Management in additional responsibilities related to the daily implementation of the Quality Management Systems required to maintain cGMP compliance and ensure the safety, efficacy and purity of the products Biogen manufactures.  
• Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required. 

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Who You Are 

You have a track record in leading teams in Quality Assurance and you thrive on leading your team to meet production and compliance guidelines. You tackle challenges head-on and propose effective solutions. You collaborate seamlessly with cross-functional teams. 

Qualifications

Required Skills

• BA or BS in scientific field with 7-10 years’ experience in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical and biotech manufacturing environments OR 
• Master's Degree (MBA/MS) with 5-7 years’ experience in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical and biotech manufacturing environments OR 
• PhD with 3-5 years’ experience in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical and biotech manufacturing environments
• Wide range of quality experience, including batch release, investigations approval, QC manufacturing investigation, and inspection management
• Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organization
• Exceptional team player and ability to develop strong network across the company and with external partners as needed
• Prior people management

Preferred Skills

• Technical expertise in manufacturing, testing, and/or technical development is a plus

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.