Sr. Manager, Quality Assurance

Biogen, Inc.; North Carolina; On-site; USD 127,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Wellness program

Disability Insurance

Paid time off

Job summary

Biogen is seeking a Sr. Manager, Quality Assurance at the RTP site to provide strategic and operational leadership for batch disposition, compliance oversight, and quality systems supporting clinical and commercial manufacturing.

The role partners with Manufacturing, Engineering, and Quality to ensure product quality and regulatory compliance, while driving continuous improvement and staff development. Applicants should have a strong GMP background, 7+ years in QA, and experience influencing

Qualifications

• Bachelor's degree in a scientific/technical field.
• 7+ years of QA experience in pharma/biotech/manufacturing.
• Experience managing personnel in QA environments.
• Strong knowledge of global regulatory requirements (FDA/EMA) and cGMP.
• Experience with QA systems: batch disposition, investigations, CAPA, change control, document management, validation.

Responsibilities

• Provide final batch disposition decisions for clinical and commercial batches.
• Lead quality oversight across multiple systems at the RTP site.
• Partner with Manufacturing, Engineering, and Quality leaders on risks and initiatives.
• Drive continuous improvement of quality systems and document lifecycle processes.
• Lead internal audits and support regulatory inspections and submissions.
• Hire, develop, and mentor QA team members.

Skills

Quality Assurance

Regulatory knowledge (FDA/EMA)

cGMP standards

Leadership/mentoring

Cross-functional collaboration

Quality systems (CAPA, change control,

Education

Bachelor's degree in scientific/technical field

Advanced degree (MS/MBA)

Tools

Quality systems in manufacturing

Job description

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.

• 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 Biogen.

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.

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 Biogen.