Sr Specialist QA - Compliance
Core
Coordinate site logistics and readiness for regulatory inspections, corporate audits, and customer audits across multi-product GMP manufacturing facilities.
Role type
Senior Specialist QA - Compliance (Site Coordinator)
Builds
Inspection readiness programs, governance processes, and audit support tools for pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
client delivery
Required skills
Regulatory compliance experience, cross-functional coordination, inspection readiness planning, document management, risk identification, gap assessment, action plan tracking, stakeholder alignment
Preferred skills
Life Sciences or Engineering degree, Health Authority inspection leadership, auditing and defending processes, pharmaceutical industry manufacturing experience, team management, cGMP knowledge, quality management systems expertise, bulk drug substance manufacturing exposure
Technologies
None explicitly stated
Responsibilities
Coordinate logistics for regulatory, corporate, internal, and customer audits; develop and maintain inspection readiness programs and tools; facilitate cross-functional alignment on inspection narratives and responses; monitor readiness of quality systems and operational processes; identify gaps and drive remediation; support site self-assessments; track regulatory commitments and follow-up actions.
Seniority
Senior, hands-on IC with leadership responsibilities
