Sr. Manager, Compliance - Quality Assurance

About this roleThe Sr. Manager, Compliance provides strategic, tactical, and operational leadership for compliance across the RTP Drug Substance Manufacturing site. This role is responsible for ensuring the site always remains inspection-ready, maintaining adherence to global regulatory requirements, and driving continuous improvement across quality systems. As a key member of the Site Quality Leadership Team, this leader partners closely with cross-functional stakeholders to strengthen compliance oversight, risk management, and data integrity while fostering a strong quality culture.What you’ll doLead site-wide compliance programs, including inspection management, regulatory interactions, and response coordinationOversee data integrity compliance across computerized and paper-based systemsOwn quality systems governance, including site quality metrics, management review, Site Master File, and Annual Product ReviewsDrive risk management activities, ensuring assessments are completed and maintained in alignment with regulatory expectationsIdentify and resolve compliance gaps, implementing improvements across quality systems and processesRepresent the site in global quality forums and contribute to the evolution of the global Quality Management SystemLead and develop a team of 5–10 direct reports, including hiring, mentoring, and performance managementPartner cross-functionally to drive data-driven decision making and continuous quality improvementWho you areYou are a collaborative and strategic quality leader with deep expertise in GMP compliance and a passion for building high-performing teams. You thrive in fast-paced manufacturing environments and bring a proactive, solutions-oriented mindset to complex regulatory challenges.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 environmentStrong knowledge of global regulatory requirements (e.g., FDA, EMA) and cGMP standardsExperience with inspection management, compliance oversight, and quality systems governanceProven leadership experience managing teams and driving performanceStrong analytical and decision-making skills, particularly in high-pressure environmentsPreferred skillsExperience with risk management, deviation management, and change control processesFamiliarity with global quality systems and cross-site collaborationDemonstrated ability to drive continuous improvement initiatives and influence at the site and global level 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.