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To ensure quality compliance in manufacturing and Quality operations, thereby assuring that products are produced and released in accordance with GSK and regulatory standards. Provide leadership to operational quality functions by ensuring quality oversight of production activities, managing batch documentation, and handling the release of finished products. Overseeing the QP team and associated processes to ensure that all products consistently meet cGMP standards and adhere to applicable license requirements. Driving consistency, continuous improvement, inspection readiness and promoting Quality culture across the site. The OQ Manager reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).
Job Responsibility:
Ensure compliant review of batch records, lab results, and release documentation
Oversee investigations for deviations, lab events, complaints, returned goods and product failures
Provide shift-based Quality oversight of facilities, equipment and operations
Ensure that quality-related systems, policies and procedures across the site are relevant and compliant
Support inspections and sustain acceptable audit status
Manage, develop and train staff
drive quality performance metrics and batch documentation lead time
Requirements:
Bachelor’s degree in life sciences, pharmacy, engineering or a related technical field
Minimum 7 years’ experience in pharmaceutical, biopharma or related regulated manufacturing in quality or operations roles
Practical experience with quality management systems and Good Manufacturing Practice (GMP) requirements
Demonstrated experience managing deviations, CAPA, change control and investigations
Strong written and verbal communication skills in English and ability to present clear, objective findings
This role is on-site in Singapore with regular presence at the manufacturing site
Nice to have:
Advanced degree in a relevant scientific or technical discipline
Auditor accreditation or progression through a recognized auditor development programme
Experience supporting regulatory inspections and responding to regulatory findings
Experience with supplier or third-party quality management and quality agreements
Knowledge of risk management, continuous improvement and project management methods
Familiarity with digital quality systems and data analytics for quality metrics