Sr. Associate III, Compliance
Biogen · Research Triangle Park, NC
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
This senior compliance role at the Research Triangle Park manufacturing site focuses on data integrity and regulatory adherence across Quality and Manufacturing. The position leads compliance initiatives, oversees electronic records and computerized systems, manages inspections, and drives cross-functional improvements aligned with FDA and global cGMP standards. Requires a bachelor's degree, 6+ years of QA experience in regulated environments, and expertise in 21 CFR Part 11 and data integrity principles.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-02 (originally posted 2026-08-18). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in scientific, technical, or related discipline
- Minimum 6 years Quality Assurance experience in pharmaceutical, biotech, or manufacturing
- Deep expertise in data integrity principles and FDA 21 CFR Part 11 regulations
- Experience with computerized systems, electronic records, and system-based reviews
- Proficiency with Quality Control environments and quality systems
- Strong analytical, organizational, and communication skills
- Ability to manage multiple priorities and drive results under pressure
What you'll be doing
- Lead data integrity compliance initiatives across manufacturing and Quality Control operations
- Ensure adherence to global regulatory requirements including 21 CFR Part 11, Annex 11, and cGMP standards
- Monitor equipment, instrumentation, and computerized systems for electronic record compliance
- Support site inspection management including scheduling, execution, and regulatory response coordination
- Develop and deliver data integrity training and awareness programs across the site
Privacy & handoff
This role links to Biogen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.