Head, PV and Regulatory QA

Proclinical Group; Thatcham; On-site; GBP 110,000 - 150,000; Full time

Job summary

Proclinical Group in the United Kingdom is seeking an experienced leader to guide global quality oversight for pharmacovigilance and regulatory affairs within a regulated healthcare environment. You will establish and maintain quality systems, monitor compliance with international expectations, and collaborate with cross-functional teams to drive operational excellence.

You will lead quality assessments, support health authority inspections, manage CAPA activities, and push continuous

Qualifications

• Bachelor's degree in a scientific or life sciences field; advanced degree preferred.
• Extensive QA experience in the pharmaceutical industry.
• Expertise in GVP, GCP and international pharmacovigilance guidelines.
• Experience leading global cross-functional teams and regulatory interactions.

Responsibilities

• Lead global quality oversight framework for pharmacovigilance and regulatory activities with central and regional teams.
• Design and maintain a risk-based quality review programme covering internal processes, partners, and affiliates.
• Coordinate regulatory inspections, quality assessments, and due diligence with preparation and follow-up actions.
• Monitor quality performance through issue management, CAPA programs, metrics, and governance.
• Advise stakeholders on PV and regulated quality requirements across research, development, medical, and commercial.
• Oversee quality system documentation, governance procedures, safety tech, and outsourced relationships.
• Lead departmental planning, including budget oversight and resource forecasting.
• Track regulatory developments and translate insights into practical quality improvements.
• Foster culture of continuous improvement, accountability, and quality awareness through leadership.

Skills

GVP & GCP expertise

Quality Assurance in pharma

Cross-functional leadership

Regulatory inspections experience

Budget and resource management

Strong communication

Education

Bachelor's degree in a scientific or life sciences field

Advanced degree preferred

Job description

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.