Associate Director, Pharmacovigilance QA

We are looking for an Associate Director, Pharmacovigilance QA to join our R&D Quality and Risk Management team on a fixed term contract basis until Summer 2027.

In this role you will be the Pharmacovigilance quality advocate. You will provide strategic, expert advice and consultation on R&D quality with impact across the regulatory and quality area of responsibility. Educating aligned groups on Quality by Design, regulatory compliance risk minimization and mitigation. You will help the business and third parties understand the potential impact of Quality risks and offer alternatives to best address the risk.

In addition, you will help R&D implement strategies for quality and getting it right first time as well as oversight according to the GSK ICF.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

• Act as the Quality Business Partner for assigned R&D functions, programmes and third parties, offering expert quality advice and supporting continuous improvement.
• Collaborate with audit and risk management teams on audits, inspections, risk assessments and CAPA activities, including readiness and regulatory support.
• Oversee quality consultation, defining and monitoring quality strategies, narratives, and critical risks for assigned areas.
• Review procedures, support due diligence and M&A, and utilise data analytics to define and report quality metrics.
• Lead investigations of serious breaches or critical issues, participate in special projects, and share learnings to promote best practice and simplification.

• BSc or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
• Experience in drug development, regulatory compliance, or quality management.
• Experience in clinical, medical, pharmacovigilance or regulatory quality.
• Expert knowledge of (one of) GCP / GVP and the post-marketing regulatory environment.

• Broad working knowledge/expertise in principles and concepts of quality by design and risk management
• Expert working knowledge in continuous improvement with a background in the appropriate tools.
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
• Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
• Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments.
• Effective communication/negotiation skills and customer management skills.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

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