PQS Associate Director
Core
Establish and sustain a proactive regulatory compliance culture and manage the Quality Management System (QMS) for a pharmaceutical manufacturing site in China.
Role type
Associate Director, Quality & Compliance (Pharmaceutical Manufacturing)
Builds
Pharmaceutical manufacturing site operations compliant with global and local regulations
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Systems & Compliance)
Required skills
GMP compliance, Quality Management System (QMS) design and maintenance, Quality Risk Management, Change Control, Validation, Complaint Management, Self-inspection, Lean tools, Regulatory intelligence, Cross-functional coordination, Statistical process control (Ppk, FMEA), SAP/Microsoft applications
Preferred skills
Experience with 3PS and CMO affairs, Global QCM localization, China market registration coordination, International regulatory affairs support
Technologies
SAP, Microsoft applications, Electronic Quality Management Systems
Responsibilities
Lead and coordinate key quality systems including GMP training, document management, and change control; Provide quality oversight for non-PET business units (QC, Engineering); Coordinate internal and external GMP inspections; Lead localization of global quality management systems; Coordinate communication with local health authorities and site registration in China; Support product registration in global and China markets; Coach and develop QA function employees.
Seniority
Senior, hands-on IC with strategic oversight