Sr. Supervisor, Quality Assurance Biologics Manufacturing
7 days ago
This position will work alongside a Swing Shift Quality team and will work from 12 PM to 12 AM on a 2,2,3 schedule.
What You'll Do
As a Sr. Supervisor Biologics Manufacturing at Biogen's Research Triangle Park (RTP) facility, you'll be a pivotal part of our Quality Assurance team. Your mission is to ensure compliance, drive excellence, and maintain product integrity.
Lead Quality Assurance
- Direct and develop team members.
- Coordinate and evaluate employees and perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures.
- Evaluate, schedule, and balance departmental workload with respect to assignments/responsibilities/personnel, management of projects, adherence to all regulatory licenses and regulations.
- Support the QA Manager/Sr. Manager/Associate Director for activities related to interviewing, hiring and training of employees, compliance with training policies, performance evaluations, and supporting resolution of employee-related issues.
Optimize Processes
- Ensure Product Disposition documentation and other documents supporting batch disposition are compliant.
- Recommend changes to existing Quality systems and GMP processes (change control).
- Identify gaps in existing Quality systems, propose solutions to QA Management and perform job functions of the QA Manager/Sr. Manager/Associate Director as delegated.
- Assess batch acceptance and final batch disposition decision for clinical and commercial production batches and final QA approval of planned exceptions and investigations.
Collaborate Across Teams
- Work closely with Manufacturing and other support functions to troubleshoot compliance issues in real time during manufacturing operations.
- Escalate quality-related issues to Quality Management to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
- Support Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections, as required.
- Maintain state of inspection readiness.
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- BA/BS degree, preferably in relevant scientific or technical discipline.
- 4 years of relevant life sciences experience within Quality Assurance and/or Quality related functions.
- Experience leading and developing a team.
- Can effectively lead change & complete initiatives aligned with the business.
- Ability to flex and respond to unexpected situations, demands.
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.
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Durham, North Carolina, United States Biogen Full timeAbout 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 activi Quality Assurance, Manufacturing, Assurance, Manager, Quality, Operations, Technology
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