Lead Quality Excellence – Head of Quality Opportunity in Pharma!
Title: Head of Quality
Reporting To: Quality Director
Industry: Life Sciences – Pharmaceuticals
Location: Essex, UK
Company Overview
My client is a well-established and rapidly evolving pharmaceutical organisation with a strong commitment to quality, compliance, and continuous improvement. Operating within a highly regulated and fast-paced environment, the company focuses on developing and delivering high-quality products to global markets. With a collaborative culture and strong leadership team, they are dedicated to excellence in everything they do.
Role Overview
This is a senior leadership opportunity for an experienced Quality professional to join a progressive pharmaceutical business as Head of Quality. In this role, you will lead the Quality and Compliance function, overseeing Quality Assurance systems and ensuring ongoing GMDP compliance across the site. You’ll work closely with cross-functional teams and senior stakeholders to align quality strategy with wider business goals, while also driving operational performance and team development. This is a highly visible role that requires both strategic leadership and hands-on operational oversight.
Responsibilities
- Lead and manage the Quality Assurance Systems, Quality Operations, Technical, and Quality Control teams.
- Drive the site’s quality strategy and lead the Quality Management Review process.
- Ensure inspection readiness for regulatory bodies and customer audits.
- Act as a senior quality representative during audits and ensure timely closure of any findings.
- Support Qualified Person (QP) certification activities in line with UK legislation.
- Champion staff development through mentoring and on-the-job training.
- Oversee deviation investigations, complaints, CAPAs, and root cause analysis.
- Own and maintain the Quality Risk Register, ensuring appropriate risk management.
- Ensure compliance with post-marketing commitments and data integrity standards.
- Collaborate cross-functionally with Regulatory, Product Development, Operations, and Supply Chain teams.
- Ensure effective documentation, SOP management, and ongoing procedural improvements.
- Promote a culture of continuous improvement and quality excellence across the organisation.
Skills / Experience
Essential:
- Proven experience in a senior QA/QC leadership role within the pharmaceutical industry or a similar regulated environment (e.g., FMCG, medical devices, aviation).
- In-depth knowledge of GMDP and regulatory compliance.
- Strong leadership, coaching, and mentoring skills.
- Track record of managing inspections and driving continuous improvement.
- Excellent communication and stakeholder engagement abilities.
- A degree in a Life Science discipline (Chemistry, Biology, Pharmacy, etc.).
- Strategic thinker with the ability to manage competing priorities in a dynamic environment.
Desirable:
- Eligibility for nomination as a Qualified Person (QP).
- Postgraduate qualification in a relevant scientific field.
- IRCA Lead Auditor certification.
- Lean Six Sigma Green Belt or equivalent quality improvement certification
Please apply or email james.allen@darwinrecruitment.com for more information.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
James Allen