Quality Compliance Senior Manager

Purpose

In this role, you will manage the Quality Compliance team to ensure that all processes, systems, and manufactured products comply with regulatory standards, GSK Quality Management System (QMS) and current Good Manufacturing Practices (cGMP).

Key responsibilities include leading and managing internal and external audits to assess compliance with GMP and other regulatory requirements, overseeing supplier management activities and managing third-party relationships to meet quality obligations, and managing the Periodic Product Review (PPR) and Periodic Validation Review (PVR) programs to ensure timely completion of required reviews.

Additionally, this role is responsible for maintaining regulatory conformance across all operations, with products being manufactured and delivered in full compliance with applicable regulations, licenses, and pharmacopeial guidelines, while maintaining the Jurong site's readiness for inspections at all times.

Responsibilities

• Lead the Quality Compliance team to provide services in the area of quality compliance, audit management, supplier management, third party relationship, regulatory conformance and sustainable GMP culture to ensure Jurong site is always inspection ready.
• Review and approve quality compliance related procedures to ensure they are in compliance with QMS requirements.
• Define and maintain a robust and effective audit management process to ensure sites are ready for internal corporate and external regulatory audits and customer audits, and all pre and post audit activities are managed and completed in well-coordinated and timely manner.
• Ensure quality related risks are identified and managed according to applicable corporate and external standards.
• Manage GxP service providers to ensure they are qualified and periodically re-qualified to meet GSK requirements. This includes the management of qualification, service provider complaints and quality agreements.
• Manage the Periodic Product Review (PPR) and Periodic Validation Review (PVR) programs to ensure reviews are completed accurately within required timelines.
• Manage and conduct audit programmes on site-managed key suppliers / service providers to ensure that they are operating in compliance with cGMP and regulatory requirements and support the performance review of these suppliers / service providers
• Lead and drive site Quality Council to ensure robust quality governance, fostering a culture of continuous improvement and quality excellence across all site operations. Facilitate monthly Quality Council meetings, set agendas and track action items.
• Manage the Regulatory Compliance team resources in support of site’s regulatory activities for strategic projects and questions or queries from health authorities for post approval changes and licenses renewal, product line extension, new product launches and frill activities.
• Manage the provision of regulatory service to internal and third-party customers such that the compliance of site business activities is maintained.
• Ensure adequate and competent resources are available to support the activities around quality compliance, audit management, supplier management, third party relationship and regulatory conformance.
• Manage, develop, and motivate staffs in the team to help realise their maximum potential to contribute towards achieving the objectives of the section and the department.
• Develop and manage the budget for the section to ensure achievement of operational targets.

Knowledge, Skills & Experience

• At least an honours degree in a relevant science or engineering discipline
• At least 10 years of relevant experience in quality environment in pharmaceutical industry
• At least 3 years in managerial position
• Good foundation of cGMP requirements
• Good audit management and regulatory understanding
• Experience in technical and quality operations
• Good interpersonal and stakeholder management skills
• Good oral and written communication skills
• Project management skills will be an advantage
• Good understand of business considerations and impact
• To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore  
• Good foundation of cGMP requirements
• Good audit management and regulatory understanding
• Experience in technical and quality operations
• Good interpersonal and stakeholder management skills
• Good oral and written communication skills
• Project management skills will be an advantage
• Good understand of business considerations and impact
• To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore  

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Why GSK?
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GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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