Senior Manager, Clinical Quality
The Opportunity
A growing bio-pharmaceutical company is seeking a Senior Manager, Clinical Quality to provide quality oversight across clinical studies and vendor programs.
This role will partner closely with clinical teams, CROs, and vendors to ensure GCP compliance, support inspection readiness, and drive quality throughout the clinical development life cycle. The ideal candidate will bring strong auditing experience, a risk-based mindset, and deep knowledge of global clinical regulations.
What You'll Do
- Provide GCP quality oversight for clinical studies, CROs, and vendors.
- Partner with study teams to identify quality risks and implement mitigation strategies.
- Conduct and manage GCP audits, including CRO, vendor, investigator site, and TMF audits.
- Support regulatory inspections, CAPAs, and inspection readiness activities.
- Review clinical processes and documentation to ensure compliance with global regulations.
- Serve as a quality advisor to cross-functional teams on GCP and compliance matters.
What You'll Bring
- Bachelor's degree in Life Sciences or a related field.
- 5+ years of GCP QA, Clinical Quality, or Compliance experience.
- Strong knowledge of ICH-GCP, FDA, EMA, and global clinical regulations.
- Experience performing GCP audits and vendor oversight activities.
- Proven ability to manage CAPAs, compliance risks, and inspection readiness efforts.
- Strong communication, collaboration, and problem-solving skills.
FAQs
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