Sr. Manager, Plant Quality Assurance – SSM & Warehouse
at Biogen
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About this roleThe 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 doLead material and batch disposition activities, including review of batch records, test results, and supporting documentationMake compliant, risk-based decisions aligned with established procedures and timelinesSupport deviation management, investigations, CAPAs, and atypical results impacting dispositionOversee daily QA activities, including GxP documentation review/approval, audit trail checks, and shop floor supportEnsure compliance with the Quality Management System, including deviations, change controls, and audit readinessPartner cross-functionally with Manufacturing, QC, Supply Chain, and MSAT to resolve operational issuesIdentify and drive continuous improvement opportunities (cycle time, right-first-time, documentation quality)Participate in site and global quality initiatives and support inspection readiness activitiesCoach and mentor team members to ensure consistent execution of quality processesWho you areA 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 skillsBachelor’s degree in scientific, technical, or relevant disciplineAt minimum 7 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environmentsPrevious experience managing personnel in a quality assurance environmentHands-on experience with batch disposition, deviation management, and cGMP complianceStrong knowledge of global regulatory requirements (FDA, EMA, etc.)Ability to assess risk and make decisions within defined quality frameworksStrong attention to detail and documentation accuracyEffective communication, organization, and time management skillsPreferred skillsExperience in Quality Operations or Quality ManagementPrior experience mentoring or coordinating team membersExposure to multiple manufacturing platforms (small scale, large scale, flexible volume)Experience supporting audits, inspections, or regulatory responsesContinuous improvement mindset with ability to identify process optimization opportunities Job Level: ManagementAdditional InformationThe base compensation range for this role is: $127,000.00-$170,000.00Base 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 insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA 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 yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participationWhy 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.
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