Senior Manager, Clinical Quality Compliance

Biogen

Senior Manager, Quality Operations and Compliance at Biogen focusing on GCP and inspection readiness. Leading quality management processes and ensuring compliance across clinical studies and programs.

Posted 7/1/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $134,000 - $179,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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

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Hard Skills & Tools

GCP KnowledgeClinical Trial RegulationsInvestigation ManagementQuality MetricsSOP Review and Approval

Soft Skills

Excellent CommunicationDecision-MakingFacilitationInfluencing StakeholdersManaging Multiple Priorities