Sr. Manager, Plant Quality Assurance - SSM & Warehouse

Responsibilities

• 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

Requirements

• 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?
• 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 backgro

Benefits

Additional Information

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.

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