Senior Manager, Clinical Quality Compliance
Location
United States
Posted
8 days ago
Salary
$134K - $179K / year
Seniority
Senior
Job Description
Senior Manager, Clinical Quality Compliance
Biogen
• 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.
Job Requirements
- 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
- 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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