Senior Director, GMP Audit Asia Pacific and South Asia

Job Title: GMP Audit Director

Location: Singapore (Asia House) (can be based anywhere in the APSA region)

About Us:

GlaxoSmithKline (GSK) is a global healthcare company that is committed to helping people do more, feel better, and live longer. We focus on the research and development of innovative pharmaceutical medicines, vaccines, and consumer healthcare products. At GSK, we are dedicated to creating a healthier world by making a difference in the lives of patients and consumers.

Job Description:

We are seeking an experienced and highly motivated individual to join our team as a GMP (Good Manufacturing Practice) Audit Senior Director. In this crucial role, you will be responsible for leading and managing the Asia Pacific and South Asia GMP Audit team to ensure compliance with regulatory requirements and GSK standards. You will play a key role in maintaining the highest standards of quality and safety across our manufacturing operations.

Key Responsibilities:

• Lead the regional APSA GMP audit program, including planning, scheduling, and executing internal and external audits.
• Develop and implement regional audit strategies and methodologies to assess compliance with GMP regulations and GSK policies of GSK Medicines and Vaccines manufacturing sites, Third Party Contractors supplying Medicines and Vaccines products, R&D GMP Contractors for GSC products, Logistics Service Providers (LSPs), and Multi-Market Warehouses and Distribution Centers.
• Accountability for the regional team’s preparation and presentation of clear, concise audit reports, highlighting findings and risks identified during audits.
• Manage the interface with senior stakeholders accountable for addressing identified audit findings and risks.
• Monitor and track the status of audit findings and drive continuous improvement for percentage of auditee CAPAs that are right first time.
• Stay current with industry trends, regulatory changes, and best practices in GMP compliance.
• Ensure team members remain current on GMP standards and auditing techniques.
• Actively support team members’ pursuit of their individual development plans.
• Drive continuous improvement of audit processes and systems.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology or Engineering
• Minimum of 10 years of experience in GMP auditing, quality assurance within the pharmaceutical or healthcare industry.
• Experience in GMP regulations (e.g., FDA, EMA) and industry standards.
• Proven track record in leading and managing audit programs and teams.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Certification in auditing (e.g., CQA, CQE) is preferred.

What We Offer:

• Competitive salary and benefits package.
• Opportunity to work with a leading global healthcare company.
• Professional development and career growth opportunities.
• Collaborative and inclusive work environment.
• Commitment to work-life balance and employee well-being.

Join GSK and make a difference in the world of healthcare. We look forward to welcoming you to our team!

GSK is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.