Head, PV and Regulatory QA

Proclinical Staffing; England; On-site; GBP 90,000 - 120,000; Full time

Job summary

Proclinical Staffing is seeking an experienced leader to head global quality oversight in pharmacovigilance and regulatory affairs. You will establish and maintain quality systems, monitor compliance with international standards, and partner with cross-functional teams to drive operational excellence.

The role requires leading quality assessments, supporting health authority inspections, managing CAPAs, and implementing continuous improvements across research, development, medical and commercial

Qualifications

• Bachelor's degree in a scientific or life sciences discipline is required or preferred.
• Strong background in QA within the pharmaceutical industry.
• Expertise in GVP and GCP regulations and international pharmacovigilance guidelines.
• Experience leading global cross-functional teams and managing regulatory interactions.

Responsibilities

• Lead global quality oversight framework for pharmacovigilance and regulatory activities.
• Design and maintain a risk-based quality review programme across processes and partners.
• Coordinate regulatory inspections and due diligence activities from preparation to follow-up.
• Drive monitoring of quality performance through CAPA, metrics and governance processes.
• Advise stakeholders on pharmacovigilance and regulated quality requirements across functions.
• Oversee quality system documentation, governance procedures, and outsourced relationships.
• Manage departmental planning, budgets, and resourcing, including contractor engagement.
• Track regulatory expectations and translate insights into practical quality improvements.

Skills

Quality Assurance

GVP & GCP expertise

Regulatory affairs

Cross-functional leadership

Budget & resource planning

Education

Bachelor's degree in a scientific or life sciences discipline

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.