Description:
GSK as an Associate Director, Quality Auditor, GVP within R&D Quality and Risk Management.
The purpose of this role is to provide independent Quality Assurance across GSK R&D by delivering comprehensive global audit programmes and influencing quality and compliance strategies. This position plays a key leadership role in ensuring compliance with international pharmacovigilance regulations, GSK policies and procedures, and industry best practices. The successful candidate will define audit scope and methodology, lead complex audits, identify emerging compliance trends, drive quality improvements across the organisation, and support regulatory inspections.
This is an influential position requiring strong leadership, expert knowledge of pharmacovigilance quality systems, and the ability to partner effectively across multiple functions and geographic regions.
Responsibilities
- Lead and deliver risk-based pharmacovigilance audits across processes, systems and third parties to assess compliance with global regulatory requirements and GSK standards.
- Develop and execute audit strategies and plans that align with organisational priorities and emerging compliance risks.
- Provide independent quality oversight by identifying compliance risks, evaluating quality systems, and recommending sustainable improvements.
- Lead discussions with senior stakeholders to communicate audit outcomes, drive effective corrective and preventive actions (CAPAs), and monitor their implementation and effectiveness.
- Analyse audit data, compliance trends, and quality metrics to identify systemic issues and opportunities for continuous improvement.
- Serve as a key quality partner during regulatory inspections and inspection readiness activities.
- Provide expert advice on pharmacovigilance regulatory expectations, quality risk management, and compliance practices.
- Influence and collaborate across global matrix teams to strengthen quality culture and compliance performance.
- Coach, mentor and develop auditors and business partners, sharing best practices and contributing to organisational capability building.
Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications:
- Bachelor's degree or equivalent in a scientific, pharmacy, life sciences, quality-related discipline, or equivalent combination of education, training and experience.
- Significant experience within the pharmaceutical industry, quality assurance and/or pharmacovigilance.
- Extensive knowledge of global pharmacovigilance regulations and quality management expectations.
- Demonstrated experience planning and leading complex quality audits.
- Experience developing corrective and preventive action strategies and evaluating effectiveness.
- Strong analytical, organisational, and planning skills.
- Proven ability to work effectively across global matrix organisations.
- Excellent verbal, written and presentation skills.
- Ability and willingness to travel domestically and internationally (approximately 25%).
Preferred Qualifications
If you have the following characteristics, it would be a plus:
- Experience leading or coordinating regulatory authority inspections.
- Broad knowledge across multiple GxP disciplines.
- Expertise in risk-based quality management, root cause analysis and quality-by-design methodologies.
- Experience using digital technologies, AI/ML solutions and data analytics to inform quality oversight activities.
- Experience auditing complex third-party and supplier relationships.
- Professional auditing certification or equivalent formal auditor training.
- Established external network within quality, compliance or regulatory organisations.
Location and Working Style
- Role based in United Kingdom or Poland.
- Home-working model.
- Regular travel to support audit execution, inspections, and stakeholder engagement activities.
- International travel expected (approximately 25%).