Sr. Manager, Plant Quality Assurance – SSM & Warehouse

Biogen•Research Triangle Park, NC

1d•$127,000 - $170,000

About The Position

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.

Requirements

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

Nice To Haves

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

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

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