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.
As discussed, Asia House can be listed as the primary location but the role can be based anywhere in the APSA region
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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