Sr. Manager, Compliance - Quality Assurance
Sr. Manager, Compliance - Quality Assurance at Biogen — Triangle, North Carolina, United States
- Company: Biogen
- Location: Triangle, North Carolina, United States
- Employment type: FULL_TIME
- Salary: USD 127000–170000 / year
- Posted: 2026-06-17
About this role
About This Role
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.
What You’ll Do
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
Who You Are
You are a collaborative and strategic quality leader with deep expertise in GMP compliance and a passion for building high-performing teams. You thrive in fast-paced manufacturing environments and bring a proactive, solutions-oriented mindset to complex regulatory challenges.
Required Skills
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
Preferred Skills
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
Job Level: Management
Additional Information
The base compensation range for this role is: $127,000.00-$170,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Benefits
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:
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
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.