Job Description
This is a full time, on-site position
About This Role
The Senior Associate III in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP activities at the Biogen Research Triangle Park (RTP) facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement.
The primary responsibilities of the Senior Associate III in the Quality Systems team include quality compliance for managing DS (Bio) site inspections, completing regulatory requests for partner and Biogen products, authoring Site Reports (Site Management Review Report and Site Master File), change control support, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation.
What You'll Do
- Management of regulatory and partner inspections and regulatory requests for the RTP DS (Bio) site through inspection set up, inspection team support, response management, closure of inspection workflows, and identifying overall inspection trends.
- Lead for site inspection activities through planning and readiness related to inspection schedule, execution and response activities.
- Process and complete regulatory requests in a timely manner to support regulatory submissions and approval status across several markets.
- Serve as quality oversight on regulatory responses in the quality system. Provide quality oversight of adequate documentation and on time closure of audit responses to any inspection findings.
- Identify and implement Quality System improvements.
- Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.
- Other duties as assigned.
Qualifications
- Bachelor's degree required, science related field preferred
- Minimum 7 years appropriate industry experience in a regulated environment within pharmaceutical or biotech manufacturing
- Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions or globally (Coordinates activities across these groups to complete compliance activities)
- Strong oral and written communication skills; ability to communicate with peers and subordinates effectively
- Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
- Expert knowledge of FDA/EMEA regulations and compliance
Preferred Skills
- Preferable competencies in QC Microbiology, QC Microbiology laboratory, testing, and Annex I requirements
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.