We’re supporting a leading global pharmaceutical organisation in appointing a senior Quality leader to oversee GCP and GVP compliance across Clinical Development, Safety, and Regulatory Affairs.
This position offers a unique opportunity for an experienced Quality professional to define global compliance strategy, strengthen inspection readiness, and embed a culture of operational excellence across diverse international teams.
You will ensure clinical trials and pharmacovigilance activities meet the highest regulatory standards (ICH, EMA, FDA), safeguarding patient safety and data integrity through proactive Quality leadership.
Key Responsibilities
* Strategic Leadership: Design and implement a global GCP and GVP Quality strategy aligned with corporate objectives and global Quality systems.
* Governance & Oversight: Establish strong governance frameworks for compliance oversight, risk management, and CAPA tracking across R&D and Safety.
* Inspection Readiness: Partner with global teams to ensure inspection readiness and manage regulatory interactions across multiple regions.
* Training & Education: Promote Quality awareness and compliance through targeted GCP/GVP training and continuous improvement initiatives.
* Team Development: Lead, mentor, and develop a high-performing Quality team that embodies integrity, accountability, and a patient-focused mindset.
Experience & Qualifications
* 10+ years of experience in GCP and/or GVP Quality Assurance within the pharmaceutical or biotechnology industry.
* Proven leadership experience managing global Quality or Compliance teams.
* Deep understanding of ICH GCP, EU PV legislation, and international regulatory expectations.
* Strong communication, stakeholder engagement, and risk management skills.
* Advanced degree in Life Sciences, Pharmacy, or a related field.