Join a cutting-edge pharmaceutical team where your precision and passion for quality assurance will help shape the future of life-saving medicines!
Proclinical is recruiting for an experienced leader with expertise in Pharmacovigilance and Regulatory Affairs to lead global quality oversight activities within a regulated healthcare environment. The successful candidate will establish and maintain effective quality systems, monitor compliance with international regulatory expectations, and partner with cross-functional teams to strengthen operational excellence. Key responsibilities include leading quality assessments, supporting health authority inspections, managing CAPA activities, and driving ongoing improvements to quality and compliance.
Responsibilities:
- Lead and evolve the global quality oversight framework for pharmacovigilance and regulatory activities, partnering with both central and regional teams to promote a consistent and compliant approach.
- Design and maintain a forward-looking, risk-based quality review programme, incorporating assessments of internal processes, external service providers, business partners, and affiliate operations.
- Coordinate and support regulatory inspections, quality assessments, and due diligence activities, ensuring effective preparation, execution, response management, and follow-up actions.
- Drive ongoing monitoring of quality and compliance performance through issue management, corrective action programmes, quality metrics, and governance processes.
- Act as a trusted adviser on pharmacovigilance and broader regulated quality requirements, providing guidance to stakeholders across research, development, medical, and commercial functions.
- Oversee quality system documentation, governance procedures, safety-related technologies, and outsourced partner relationships to ensure operational effectiveness and regulatory compliance.
- Manage departmental planning activities, including budget oversight, resource forecasting, and engagement of specialist contractors or consultants where required.
- Track emerging regulatory expectations, industry developments, and best practices, translating insights into practical enhancements that strengthen quality systems and operational excellence.
- Foster a culture of continuous improvement, accountability, and quality awareness across the organisation through proactive leadership and stakeholder engagement.
Key Skills and Requirements:
- Bachelor's degree in a scientific or life sciences discipline; an advanced degree is preferred.
- Strong background in Quality Assurance within the pharmaceutical industry.
- Expertise in GVP and GCP regulations, as well as international pharmacovigilance guidelines.
- Comprehensive understanding of pharmacovigilance processes, including deviation and CAPA management.
- Experience leading global cross-functional teams and managing complex regulatory interactions.
- Excellent strategic thinking, decision-making, and problem-solving skills.
- Strong communication, negotiation, and influencing abilities across all organizational levels.
- Proven ability to manage budgets, resources, and operational plans effectively.
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Head, PV and Regulatory QA in Thatcham employer: Proclinical Group
Join a globally recognised biopharmaceutical organisation that is at the forefront of innovative therapies, where your passion for protein science and biologic drug development can truly make a difference. With a strong commitment to employee growth, you will thrive in a collaborative work culture that values scientific excellence and offers opportunities to contribute to life-changing therapies. Located in a dynamic environment, this role not only provides hands-on laboratory experience but also fosters professional development through cross-functional teamwork and cutting-edge research.
