Compliance Specialist Lead
Core
Lead Regulatory and Quality Compliance Initiatives and oversee the GMP Internal Audit program to ensure compliance with regulatory agency requirements, internal standards, client requirements, and cGMPs.
Role type
Senior IC compliance specialist lead (GMP/Regulatory)
Builds
Internal audit programs, corrective action tracking, site governance, and SOPs for a biologic manufacturing facility
Domain
Biotechnology / Pharmaceutical manufacturing (cGMP)
Required skills
GMP compliance, internal audit planning and execution, corrective action tracking, regulatory agency interaction, quality system management, SOP development, risk management, cross-functional partnership
Preferred skills
ASQ-CQA certification, project or program management
Technologies
None stated
Responsibilities
Own the Internal Audit process (planning, execution, verification), support Regulatory Compliance/Quality Representatives, track corrective actions, update Site Governance and SOPs, support Management Review and KPI monitoring, partner with internal departments for end-to-end compliance
Seniority
Senior, hands-on IC
