Sr Manager, Clinical Quality Compliance
Biogen
July 01, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Senior Manager, Quality Operations and Compliance (QOC)
Responsibilities:
- Serve as quality lead for assigned clinical studies/programs, guiding GCP compliance and quality expectations.
- Lead/support the Study Risk Assessment (SRA) process and inspection readiness activities.
- Conduct/manage investigations, root cause analyses, and oversee CAPAs and Effectiveness Checks.
- Evaluate/escalate quality risks with stakeholders and support development of mitigation strategies.
- Partner with internal/external teams to ensure proper documentation, risk management, and audit/inspection response planning.
- Support audit planning and regulatory inspection preparation; contribute to inspection management strategies.
- Participate in cross-functional/process improvement initiatives to enhance quality system effectiveness across RD&M.
- Review/approve controlled documents, CAPAs, and SOPs per quality standards and regulatory requirements.
Required Skills/Qualifications:
- Bachelor’s degree.
- 5+ years’ experience in clinical research, clinical quality, or clinical compliance.
- Strong working knowledge of GCP and global clinical trial regulations (ICH, CFR, EU Clinical Trial Regulation).
- GCP Quality and GCP inspection experience.
- Hands-on experience supporting regulatory inspections and audits.
- Proven experience with investigations and CAPAs.
- Knowledge of clinical trial systems, quality metrics, and risk management.
- Excellent facilitation, communication, and decision-making; manage multiple priorities and influence stakeholders.
Preferred:
- Master’s/advanced degree in life sciences/quality/regulatory.
- CRA experience or direct experience with clinical investigator sites.
- Quality role experience supporting clinical/pharmaceutical operations.
- Experience working with CROs/external vendors.
Benefits (as listed): Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability; 15+ days paid vacation and year-end shutdown (Dec 26–31); paid holidays + personal days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation.
Responsibilities:
- Serve as quality lead for assigned clinical studies/programs, guiding GCP compliance and quality expectations.
- Lead/support the Study Risk Assessment (SRA) process and inspection readiness activities.
- Conduct/manage investigations, root cause analyses, and oversee CAPAs and Effectiveness Checks.
- Evaluate/escalate quality risks with stakeholders and support development of mitigation strategies.
- Partner with internal/external teams to ensure proper documentation, risk management, and audit/inspection response planning.
- Support audit planning and regulatory inspection preparation; contribute to inspection management strategies.
- Participate in cross-functional/process improvement initiatives to enhance quality system effectiveness across RD&M.
- Review/approve controlled documents, CAPAs, and SOPs per quality standards and regulatory requirements.
Required Skills/Qualifications:
- Bachelor’s degree.
- 5+ years’ experience in clinical research, clinical quality, or clinical compliance.
- Strong working knowledge of GCP and global clinical trial regulations (ICH, CFR, EU Clinical Trial Regulation).
- GCP Quality and GCP inspection experience.
- Hands-on experience supporting regulatory inspections and audits.
- Proven experience with investigations and CAPAs.
- Knowledge of clinical trial systems, quality metrics, and risk management.
- Excellent facilitation, communication, and decision-making; manage multiple priorities and influence stakeholders.
Preferred:
- Master’s/advanced degree in life sciences/quality/regulatory.
- CRA experience or direct experience with clinical investigator sites.
- Quality role experience supporting clinical/pharmaceutical operations.
- Experience working with CROs/external vendors.
Benefits (as listed): Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability; 15+ days paid vacation and year-end shutdown (Dec 26–31); paid holidays + personal days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation.