Deskripsi Pekerjaan
Join GSK as a QA Validation Manager and drive excellence in quality assurance across our manufacturing operations. This pivotal role requires you to provide comprehensive site-level oversight of validation and qualification activities, ensuring compliance with stringent regulatory standards and GMP requirements. You will lead critical initiatives that safeguard product quality while optimizing operational efficiency in a dynamic pharmaceutical environment.
As a key member of our quality leadership team, you'll develop and implement robust validation strategies, coordinate cross-functional projects, and mentor validation professionals. Your expertise in risk assessment and protocol execution will directly impact our manufacturing processes and product lifecycle management. This position offers the opportunity to shape quality standards while contributing to GSK's mission of improving global health outcomes.
GSK offers a collaborative culture that values innovation, integrity, and patient-centricity. We provide competitive compensation, professional development opportunities, and a supportive environment where quality leaders can thrive. If you're passionate about elevating quality standards and making a tangible impact in pharmaceutical manufacturing, we encourage you to apply.
Tanggung Jawab
- Provide comprehensive oversight of validation and qualification activities across manufacturing processes
- Lead and mentor validation teams, ensuring execution of validation strategies and protocols
- Ensure compliance with GMP regulations, FDA requirements, and international quality standards
- Develop and implement risk-based validation approaches for complex manufacturing systems
- Coordinate cross-functional validation projects with engineering, production, and quality teams
- Review and approve validation documentation, including protocols, reports, and change controls
- Drive continuous improvement initiatives in validation processes and quality systems
- Represent QA in regulatory inspections and internal quality audits
Kualifikasi
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related technical field
- Minimum 8 years of experience in quality assurance with 3+ years in validation leadership
- Deep expertise in GMP regulations, validation principles, and pharmaceutical quality systems
- Proven track record in managing validation projects across manufacturing operations
- Certification in quality management (e.g., CQA, RAC) or validation methodologies preferred
- Strong analytical skills with ability to interpret complex technical data and regulatory requirements
- Excellent leadership abilities with experience managing cross-functional teams
- Experience with regulatory inspections and compliance documentation