GLP Preclinical Quality & Compliance Manager
Posted 1 day ago by 1756882613
Negotiable
Outside
Remote
USA
Summary: The GLP Preclinical Quality & Compliance Manager is responsible for overseeing GLP-related processes and preclinical activities, ensuring compliance with FDA GLPs and global standards. This role involves collaboration with R&D and Quality teams, supporting vendor audits and inspection readiness. The ideal candidate should possess extensive experience in GLP quality and demonstrate strong problem-solving and collaboration skills.
Key Responsibilities:
- Provide quality oversight of GLP-related processes and preclinical activities.
- Partner with R&D and Quality teams to ensure compliance with FDA GLPs and global equivalents.
- Support vendor audits, inspection readiness, and quality governance.
Key Skills:
- 10+ years of experience with a M.S. or 13+ years with a B.S. in GLP quality.
- Strong problem-solving skills.
- Proven ability to foster collaboration and a culture of quality.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
- Note: This position requires up to 15% travel
- We are seeking a Manager, GLP Operational Quality to provide quality oversight of GLP-related processes and preclinical activities.
- This role will partner with R&D and Quality teams to ensure compliance with FDA GLPs (21 CFR Part 58) and global equivalents, support vendor audits, inspection readiness, and quality governance.
- The ideal candidate has 10+ years of experience (M.S.) or 13+ years (B.S.) in GLP quality, strong problem-solving skills, and proven ability to foster collaboration and a culture of quality.