About This RoleThe Senior Manager, Quality Operations and Compliance (QOC), serves as a Functional Quality Representative (FQR) and plays a key role in advancing quality oversight and compliance across Research, Development & Medical (RD&M). This role supports the implementation of Biogen's Quality Management System (QMS), focusing on Good Clinical Practice (GCP) and inspection readiness. The incumbent partners closely with clinical study teams, functional leaders, and vendor quality teams to manage quality issues, lead risk assessments, and ensure audit and inspection preparedness. This position also supports the identification and resolution of quality issues and the implementation of Corrective and Preventive Actions (CAPAs) to drive continuous improvement.
What You'll Do- Serve as the quality lead for assigned clinical studies and programs, providing guidance on GCP compliance and quality expectations.
- Lead and support the Study Risk Assessment (SRA) process and proactively engage in inspection readiness activities.
- Conduct and manage investigations, root cause analyses, and the development and oversight of CAPAs and Effectiveness Checks.
- Collaborate with stakeholders to evaluate and escalate quality risks, and contribute to the development of mitigation strategies.
- Partner with internal and external teams to ensure appropriate documentation, risk management, and audit/inspection response planning.
- Support audit planning and regulatory inspection preparation, contributing to inspection management strategies and coordination.
- Participate in cross-functional and process improvement initiatives to enhance quality system effectiveness across RD&M.
- Review and approve controlled documents, CAPAs, and SOPs in alignment with quality standards and regulatory requirements.
Who You AreYou are a quality-minded professional with hands-on GCP experience and a deep understanding of clinical operations and regulatory expectations. You are confident in leading risk-based quality assessments, managing CAPAs, and supporting inspections. You're a team player with excellent communication skills, and you thrive in a cross-functional, fast-paced environment.
Required Skills- Bachelor's degree required.
- Minimum 5 years' experience in clinical research, clinical quality, or clinical compliance required.
- Strong working knowledge of GCP and global clinical trial regulations (e.g., ICH, CFR, EU Clinical Trial Regulation).
- GCP Quality experience required.
- GCP inspection experience required.
- Hands-on experience supporting regulatory inspections and audits.
- Proven experience conducting investigations and managing CAPAs.
- Knowledge of clinical trial systems, quality metrics, and risk management.
- Excellent facilitation, communication, and decision-making skills.
- Ability to manage multiple priorities and influence cross-functional stakeholders.
Preferred Skills- Master's degree or advanced degree in a life sciences, quality, or regulatory field.
- Clinical Research Associate (CRA) experience or direct experience with clinical investigator sites.
- Experience in a Quality role supporting clinical or pharmaceutical operations
- Experience working with CROs or external vendors.
Job Level: ManagementAdditional InformationThe base compensation range for this role is: $134,000.00-$179,000.00
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
