Senior Manager, Clinical Quality Compliance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $134k - $179k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• 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

• 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