job description
Are you an experienced Quality Assurance professional looking to make a significant impact in a world-leading biopharma environment? GSK is seeking a QA Validation Manager to join our site operations in Tuas. In this critical role, you will be the cornerstone of our quality oversight, ensuring that all validation and qualification activities adhere to global regulatory standards and internal GSK excellence frameworks.
You will lead cross-functional engagement, collaborating with Engineering, Production, and IT teams to ensure manufacturing systems, equipment, and processes are consistently validated. This position offers the opportunity to drive continuous improvement initiatives while maintaining the highest levels of compliance in a fast-paced, innovative manufacturing facility.
Responsibility
- Provide expert site-level quality oversight for validation and qualification activities across manufacturing and utility systems.
- Review and approve validation master plans, protocols, and reports to ensure compliance with cGMP and GSK global standards.
- Lead and facilitate risk assessments for validation activities, including Quality Risk Management (QRM) processes.
- Manage the lifecycle of validation documentation, ensuring all records are inspection-ready and maintain data integrity.
- Support regulatory inspections and internal audits by acting as a technical SME for validation-related inquiries.
- Drive continuous improvement in validation processes to enhance operational efficiency and reduce quality deviations.
- Collaborate with cross-functional stakeholders to oversee the validation of computerized systems (CSV) and analytical equipment.
Qualifications
- Bachelor’s degree in Engineering, Pharmacy, Chemistry, or a related scientific discipline.
- Minimum 5-8 years of experience in QA Validation within the pharmaceutical, biotech, or medical device industry.
- In-depth knowledge of international regulatory requirements (FDA, EMA, HSA, ICH guidelines).
- Proven experience in managing Equipment Qualification (IQ/OQ/PQ) and Process Validation.
- Strong understanding of Data Integrity principles and GAMP 5 methodologies.
- Excellent communication skills with the ability to influence stakeholders at all levels of the organization.
- Professional certification (e.g., CQA, Six Sigma) is considered a strong advantage.