About the Role
WuXi Biologics is seeking a high-caliber Senior Quality Assurance Manager to join our expanding Singapore team. In this critical role, you will act as the primary Quality Assurance partner for our Quality Control (QC) operations. You will ensure that our testing, laboratory systems, and data integrity standards meet global regulatory expectations as we deliver life-saving biologics to patients worldwide.
Location: Tuas Biomedical Park, Company shuttle bus is provided island
Responsibilities:
- Perform quality monitoring of QC testing to ensure all operations align with SOPs and comply with GMP requirements.
- Review batch analytical records for drug substances and drug products to ensure data accuracy and compliance.
- Manage QC equipment and area release, including assessing alarms, overseeing handling processes, and approving release requests for facilities, instruments, and computerized systems.
- Verify completion of Data Integrity (DI) checks before system release and maintain updated inventories of all QC computerized systems.
- Review and approve specifications, sampling procedures, test methods, CoAs, and stability protocols/reports for raw materials, excipients, intermediates, drug substances, and drug products.
- Execute electronic data reviews prior to routine batch release and as part of the periodic review program, including the assessment of abnormal findings.
- Review Quality Risk Management (QRM) documents, quality statements, SOPs, URS, and validation or qualification protocols/reports for the QC department.
- Review and approve laboratory investigation reports and excursion investigation records.
- Oversee QC-related change controls and deviations, ensuring timely initiation, closure of minor changes, and completion of CAPA effectiveness checks.
- Conduct routine internal QC laboratory audits with a specific focus on data integrity aspects.
- Provide technical support for external client audits and health authority inspections.
Requirement:
- Bachelor's degree or higher in Pharmacy, Microbiology, Biotechnology, Biomedical Medicine, or a related scientific discipline.
- Min 8 -10 years of proven professional experience in pharmaceutical production or quality management with specific expertise in QA oversight for biologics or sterile dosage manufacturing
- In-depth knowledge of global regulatory standards, including US 21 CFR, EU GMP, and PIC/S GMP guidelines.
- Comprehensive understanding of pharmaceutical quality systems and QC operations, including instrument qualification and test method validation/verification.
- Demonstrated ability to collaborate effectively in cross-functional team environments.
- Experience in people leadership or management is highly advantageous.
- Highly organized with the ability to plan, prioritize, and manage complex activities independently.
- Strong analytical and problem-solving skills, with the ability to troubleshoot and manage corrective actions.
- Committed to quality risk management and the continuous optimization of processes.
