Biogen
About This Role
The 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 Are
You 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.
Why Biogen?
Our mission to discover, develop, and deliver therapies for neurological and rare diseases unites us in purpose. We are driven by science and compassion, working collaboratively to overcome obstacles and make a meaningful impact on patients’ lives. At Biogen, we pioneer together. We thrive together.
Job Level: Management
Additional Information
The 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:
Why 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 Biogen.
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.