Lead Qualified Person (QP) – Multi-Site Pharmaceutical Organisation (UK-Wide)
We are seeking an experienced Lead Qualified Person to join a leading pharmaceutical organisation, overseeing a team of QPs across multiple UK sites. This is a senior leadership role, ensuring the highest standards of GMP compliance, product release, and regulatory alignment across the organisation’s operations.
Key Responsibilities:
- Strategic QP Leadership: Oversee and provide guidance to a team of Qualified Persons across multiple UK sites, ensuring consistent quality and regulatory compliance.
- Batch Certification & Product Release: Lead the QP function in certifying and releasing medicinal products in accordance with EU GMP and MHRA requirements.
- Regulatory & Compliance Oversight: Ensure all sites maintain full compliance with MHRA, EU GMP, and GDP regulations, supporting regulatory inspections and audits.
- Process Improvement & Risk Management: Identify and mitigate quality risks, implement Corrective and Preventive Actions (CAPAs), and drive continuous improvement across the QP function.
- Training & Development: Mentor and develop the QP team, ensuring ongoing training, competency, and professional development.
- Stakeholder Collaboration: Work closely with senior management, manufacturing, quality, and regulatory teams to align QA and QP activities with business objectives.
What We’re Looking For:
- Eligibility to act as a Qualified Person.
- Proven experience in a senior QP role, ideally leading QPs.
- Strong knowledge of GMp, MHRA regulations, and pharmaceutical quality systems.
- Must have exposure to releasing sterile/aseptic dosage forms.
- Demonstrated leadership skills with the ability to manage, mentor, and develop a high-performing team.
- Experience in audits, inspections, and batch release for a variety of pharmaceutical products.
This is a unique opportunity to take on a senior QP leadership role within a well-established pharmaceutical organisation. If you are a strategic leader with a passion for quality excellence and compliance, we would love to hear from you!
