Sr. Manager, Plant Quality Assurance - SSM & Warehouse

About this role

The Sr. Manager, Plant Quality Assurance plays a critical role in ensuring the quality and compliance of manufacturing operations. This position is responsible for leading material and batch disposition activities across multiple manufacturing platforms, supporting both clinical and commercial supply. Working cross-functionally with Manufacturing, Quality Control, Supply Chain, and MSAT, this role ensures decisions are accurate, timely, and aligned with Biogen's Quality Management System, while driving a strong quality and compliance mindset across operations.

What you'll do

• Lead material and batch disposition activities, including review of batch records, test results, and supporting documentation
• Make compliant, risk-based decisions aligned with established procedures and timelines
• Support deviation management, investigations, CAPAs, and atypical results impacting disposition
• Oversee daily QA activities, including GxP documentation review/approval, audit trail checks, and shop floor support
• Ensure compliance with the Quality Management System, including deviations, change controls, and audit readiness
• Partner cross-functionally with Manufacturing, QC, Supply Chain, and MSAT to resolve operational issues
• Identify and drive continuous improvement opportunities (cycle time, right-first-time, documentation quality)
• Participate in site and global quality initiatives and support inspection readiness activities
• Coach and mentor team members to ensure consistent execution of quality processes

Who you are

A detail-oriented quality leader who thrives in a fast-paced, regulated manufacturing environment. You bring a strong compliance mindset, sound decision-making skills, and the ability to collaborate across teams to ensure high-quality outcomes.

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
• Hands-on experience with batch disposition, deviation management, and cGMP compliance
• Strong knowledge of global regulatory requirements (FDA, EMA, etc.)
• Ability to assess risk and make decisions within defined quality frameworks
• Strong attention to detail and documentation accuracy
• Effective communication, organization, and time management skills

Preferred skills

• Experience in Quality Operations or Quality Management
• Prior experience mentoring or coordinating team members
• Exposure to multiple manufacturing platforms (small scale, large scale, flexible volume)
• Experience supporting audits, inspections, or regulatory responses
• Continuous improvement mindset with ability to identify process optimization opportunities

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

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.

Client-provided location(s): Research Triangle Park, NC

Job ID: Biogen-REQ23504

Employment Type: FULL_TIME

Posted: 2026-06-09T23:59:04