QC Manager

About the role

West Pharmaceutical Services is looking for a QC Manager in Jurong to lead the Quality Control team and oversee end-to-end quality control, from mold monitoring and incoming material control to inspection of in-process, semi-finished and finished goods and batch release. The role works closely with Production, Engineering, Supply Chain, Technology Transfer and Quality Assurance to drive investigations, technical support and continuous improvement.

Key responsibilities

• Manage the QC team (Associate Managers, Engineers, Team Leads and Technicians) so that mold monitoring, incoming material sampling and testing, and IPC, SFG and FG visual and dimensional inspections run on time and meet cGMP requirements.
• Oversee incoming material and batch release so only conforming products are released according to approved specifications, inspection plans and records.
• Review and approve inspection and testing results, product disposition decisions and quality records for raw materials, in-process, semi-finished and finished goods.
• Own raw material inquiries on inspection plans and RMTS, and create, review and revise inspection plans in SAP.
• Support technology transfer, including risk assessment, equivalency studies, part number setup and validation support.
• Review gamma irradiation certificates and Certificates of Analysis, prepare COAs for customer requests, and manage low-yield and rheology deviations with root cause analysis and CAPA.
• Handle deviations, OOS and non-conforming products, apply containment and segregation decisions, and trend data to drive continuous improvement.
• Run regular process audits and Gemba walks, maintain compliance with ISO 15378, ISO 9001 and other standards, and develop, coach and qualify team members.

Required profile

• Minimum Bachelor's degree or equivalent in Science, Engineering, Life Sciences or a related discipline.
• Minimum 8 years in quality control and/or quality assurance in a cGMP manufacturing environment.
• Minimum 5 years of people management or supervisory experience.
• Pharmaceutical or medical device manufacturing experience preferred.

Required skills

• Strong knowledge of cGMP, GDP and Data Integrity (ALCOA+).
• Good working knowledge of ISO 15378, ISO 9001 and customer/specification requirements.
• Root cause analysis, CAPA and tools such as A3 or Six Sigma.
• Experience with SAP or other quality/ERP systems is advantageous.