Senior Manager, Clinical Quality — GCP Compliance & Audits

EPM Scientific; Florham Park (NJ); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

EPM Scientific partners with a growing bio-pharmaceutical company to recruit a Senior Manager, Clinical Quality. This role provides quality oversight across clinical studies and vendor programs, ensuring GCP compliance and inspection readiness throughout the clinical development lifecycle.

The ideal candidate brings 5+ years in GCP QA/Clinical Quality, with deep knowledge of ICH-GCP, FDA, EMA, and global regulations, plus strong auditing and CAPA management capabilities.

Qualifikationen

• Bachelor's degree in Life Sciences or related field is required.
• 5+ years of GCP QA, Clinical Quality, or Compliance experience preferred.
• Strong knowledge of ICH-GCP, FDA, EMA, and global clinical regulations is essential.

Aufgaben

• 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.

Kenntnisse

GCP QA

Clinical Quality

Compliance

GCP audits

CAPAs

Inspection readiness

ICH-GCP

FDA/EMA regs

Regulatory knowledge

Communication

Collaboration

Problem-solving

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

EPM Scientific partners with a growing bio-pharmaceutical company to recruit a Senior Manager, Clinical Quality. This role provides quality oversight across clinical studies and vendor programs, ensuring GCP compliance and inspection readiness throughout the clinical development lifecycle.

The ideal candidate brings 5+ years in GCP QA/Clinical Quality, with deep knowledge of ICH-GCP, FDA, EMA, and global regulations, plus strong auditing and CAPA management capabilities.