About This Role
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.
What You'll Do
- 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.
Who You Are
You are a collaborative quality leader who thrives in complex, highly regulated environments. You combine deep GMP expertise with strong business judgment, excel at building partnerships across functions, and are passionate about developing people while driving a culture of quality and continuous improvement.
Required Skills
- 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
Preferred Skills
- 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
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.
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
