Sr. Manager, Quality Assurance
About The Position
At Biogen, quality is at the center of everything we do. We are seeking a Sr. Manager, Quality Assurance to provide strategic and operational leadership for batch disposition, compliance oversight, and quality systems supporting clinical and commercial manufacturing at our Research Triangle Park (RTP) site. This is a highly visible leadership role that partners across Manufacturing, Engineering, and Quality organizations to ensure product quality, regulatory compliance, and continuous improvement. The successful candidate will lead a team of quality professionals while driving initiatives that strengthen quality systems and support Biogen's mission of serving patients worldwide.
Requirements
- Bachelor’s degree in scientific, technical, or relevant discipline from an accredited college or university
- 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 quality systems including batch disposition, investigations, CAPA, change control, document management, and validation activities
- Ability to lead cross-functional initiatives and drive continuous improvement
Nice To Haves
- Advanced degree (MS, MBA, or related field)
- Experience supporting both clinical and commercial manufacturing operations
- Demonstrated success leading quality system improvements and compliance initiatives in a large-scale biotech manufacturing environment
- Experience presenting quality metrics and recommendations to executive leadership
- Prior experience leading internal audits and supporting regulatory inspections
Responsibilities
- Lead quality oversight activities across multiple quality systems to ensure the safety, efficacy, and quality of products manufactured at the RTP facility.
- Provide final batch disposition decisions and assessments for clinical and commercial manufacturing batches.
- Partner with Manufacturing, Engineering, and Quality leaders to address compliance risks, operational challenges, and strategic initiatives.
- Drive continuous improvement of quality systems, including change control, CAPA, investigations, exception management, and document lifecycle processes.
- Analyze site quality metrics, identify trends, and proactively implement solutions to improve performance and compliance.
- Lead internal audits and support regulatory inspections and submissions.
- Hire, develop, mentor, and lead a team of quality professionals while managing department priorities and resources.
- Serve as a key quality representative on cross-functional and global teams to drive business and patient-focused outcomes.
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
