Qualified Person (QP) – Pharmaceutical Manufacturing & Quality

Qualified Person (QP) – Pharmaceutical Manufacturing & Quality

Industry: Global Pharmaceuticals / Life Sciences

Location: London, United Kingdom (On-site / Manufacturing & Corporate Quality Office)

Type: Full-Time, Permanent

Salary Band: £90,000 – £110,000 + Benefits

Experience Level: Senior (8–15 Years)

The Role (Why This Exists):

We are supporting a global pharmaceutical organisation operating in highly regulated UK and EU markets, seeking a Qualified Person (QP) to take full legal and technical ownership of batch certification, GMP compliance, and regulatory alignment across UK and European operations.

This is a hands‑on, accountable QP role where you act as the final legal authority between manufacturing and patient release.

What You’ll Be Accountable For:

Batch Certification & Manufacturing Oversight:

• Legally certify pharmaceutical batches in line with UK law and EU Directives
• Ensure manufacturing and testing activities comply with GMP and Marketing Authorisations
• Oversee internal and third‑party manufacturing partners

Quality Systems & Compliance Leadership:

• Own and maintain the Quality Management System (QMS)
• Lead governance of:
• Deviations
• CAPAs
• Change Controls
• Annual Product Reviews (APR)
• Self‑Inspections & Audits

Regulatory & Authority Engagement:

• Act as a senior quality interface with MHRA and EU regulatory bodies
• Support inspections, manufacturing line approvals, and regulatory submissions

Cross‑Functional Leadership:

• Partner with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams
• Lead GMP training and SOP development across UK/EU operations

Quality Risk & Patient Safety:

• Own recall processes and escalation pathways
• Proactively identify and mitigate quality risks impacting patient safety

Must‑Haves (Non‑Negotiable):

• Eligible to act as a Qualified Person under UK law (Directive 2001/83/EC)
• 4–5+ years operating as a named QP in regulated pharmaceutical environments
• Degree in Pharmacy, Chemistry, Biology, or related life sciences
• Deep hands‑on experience with: GMP manufacturing operations; Batch certification and regulatory documentation; Pharmaceutical Quality Systems
• Experience within large or multi‑site pharmaceutical organisations

Nice‑to‑Haves:

• UK/EU multi‑site manufacturing oversight
• Third‑party manufacturer and Quality Agreement management
• Regulatory audit leadership
• On‑site role spanning manufacturing facilities and corporate quality office (London)
• Close collaboration with production, QA, regulatory, and leadership teams
• 2–3 stage interview process, including technical and compliance assessment

Compliance & Eligibility:

• UK Citizens / Permanent Right to Work required
• Notice Period: 30–45 days preferred
• This is a site‑based role (not remote / hybrid)

Application Process:

To apply, please submit your CV and a cover letter detailing your relevant experience and qualifications for the role. Applications will be reviewed on a rolling basis, so early submissions are encouraged.

Equal Opportunity Employer:

We value diversity and are committed to creating an inclusive work environment. We encourage applicants from all backgrounds to apply.