PQS Associate Director
Core
Establish and sustain a proactive regulatory compliance culture, manage quality systems, and coordinate oversight of functional quality & compliance for a pharmaceutical manufacturing site.
Role type
Associate Director, Quality & Compliance
Builds
Pharmaceutical manufacturing site operations compliant with global and local regulations
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP and quality system management, Quality risk management, Process control methodology and statistics (Ppk, FMEA), Regulatory intelligence and compliance, Change control, Validation, Document management, Lean tools for continuous improvement, Cross-functional coordination, Training and coaching
Preferred skills
Experience with 3PS and CMO affairs, Global QCM localization, SAP or similar systems
Technologies
SAP, Microsoft applications
Responsibilities
Lead and coordinate key quality systems (GMP training, document management, QAA, change control, risk management, self-inspection, complaints, management review), Support non-PET business units (QC, E&SHE) with quality oversight, Lead intelligence of external regulations and provide compliance advice, Coordinate internal/external GMP inspections, Coordinate site registration in China and support CMCRA/China RA for global and local product registration, Maintain and improve PQS procedures and electronic systems, Provide quality system training and develop QA function capabilities, Coordinate communication with local health authorities.
Seniority
Senior, hands-on IC with leadership responsibilities
