Head of Quality - RPi – Pharmaceuticals
Location: Central London | Hybrid/On-Site | Full-Time
We are looking for a Quality Assurance Lead to oversee compliance, risk management, and continuous improvement within our pharmaceutical operations. This role ensures that all GMP, GDP, and GPvP regulations are met while maintaining the highest standards of product quality and safety.
Key Responsibilities
Leadership & Compliance
* Lead and develop the Quality Assurance team, fostering a culture of accountability and excellence.
* Maintain compliance as a Manufacturing Authorisation Holder (MAH), ensuring adherence to all GxPstandards.
* Oversee regulatory inspections, audits, and quality risk assessments, ensuring timely implementation of corrective and preventive actions (CAPAs).
* Act as the primary liaison with regulatory agencies and external stakeholders on quality matters.
Quality Management & Continuous Improvement
* Manage and enhance the Quality Management System (QMS), including the maintenance of SOPs, documentation, and eQMS improvements.
* Implement risk assessments and mitigation strategies throughout the product lifecycle.
* Drive compliance initiatives through internal training, education, and process improvement programs.
* Monitor and report on quality metrics (KPIs), including deviation rates, CAPAs, and customer complaints.
Operational Oversight
* Ensure adherence to standard operating procedures in line with GMP, GDP, and GPvP practices.
* Manage product quality complaints, supplier qualifications, and technical agreements with third-party service providers.
* Support cross-functional teams, including supply chain, pharmacovigilance, regulatory affairs, and manufacturing, to align quality objectives.
* Ensure compliance with change controls, deviations, non-conformances, and internal audit observations.
About You
* Strong knowledge of GDP, GMP, and GPvP in the pharmaceutical industry.
* Experience in leading quality teams with a proven track record in compliance and regulatory affairs.
* Eligible or experienced Responsible Person (RP) and Responsible Person for Import (RPi).
* Familiarity with eQMS, risk management, CAPAs, and supplier oversight.
* Strong analytical, communication, and leadership skills with the ability to influence at all levels.
* Degree in Life Sciences or equivalent.
If you are a results-driven quality leader ready to take on a high-impact role in a fast-paced, compliance-drivenenvironment, we would love to hear from you.
Apply now or reach out for a confidential discussion