Sr. Manager, Compliance - Quality Assurance
Biogen•Research Triangle Park, NC
•$127,000 - $170,000•Onsite
About The Position
The Sr. Manager, Compliance provides strategic, tactical, and operational leadership for compliance across the RTP Drug Substance Manufacturing site. This role is responsible for ensuring the site always remains inspection-ready, maintaining adherence to global regulatory requirements, and driving continuous improvement across quality systems. As a key member of the Site Quality Leadership Team, this leader partners closely with cross-functional stakeholders to strengthen compliance oversight, risk management, and data integrity while fostering a strong quality culture.
Requirements
- Bachelor’s degree in scientific, technical, or relevant discipline
- At minimum 7 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
- Previous experience managing personnel in a quality assurance environment
- Strong knowledge of global regulatory requirements (e.g., FDA, EMA) and cGMP standards
- Experience with inspection management, compliance oversight, and quality systems governance
- Proven leadership experience managing teams and driving performance
- Strong analytical and decision-making skills, particularly in high-pressure environments
Nice To Haves
- Experience with risk management, deviation management, and change control processes
- Familiarity with global quality systems and cross-site collaboration
- Demonstrated ability to drive continuous improvement initiatives and influence at the site and global level
Responsibilities
- Lead site-wide compliance programs, including inspection management, regulatory interactions, and response coordination
- Oversee data integrity compliance across computerized and paper-based systems
- Own quality systems governance, including site quality metrics, management review, Site Master File, and Annual Product Reviews
- Drive risk management activities, ensuring assessments are completed and maintained in alignment with regulatory expectations
- Identify and resolve compliance gaps, implementing improvements across quality systems and processes
- Represent the site in global quality forums and contribute to the evolution of the global Quality Management System
- Lead and develop a team of 5–10 direct reports, including hiring, mentoring, and performance management
- Partner cross-functionally to drive data-driven decision making and continuous quality improvement
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
