Qualified Person (QP) – QA Operations Manager

Qualified Person (QP) – QA Operations Manager

Qualified Person (QP) – QA Operations Manager

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QA Operations Manager & Qualified Person (QP)

Location: United Kingdom (Hybrid – 3 days on-site)

Industry: Pharmaceutical Manufacturing

Employment Type: Full-time

About the Role

We are partnering with a well-established pharmaceutical manufacturing company to hire a QA Operations Manager & Qualified Person (QP) to join their UK-based team. This is a key position supporting GMP compliance and sterile manufacturing operations, with direct responsibility for batch release and leadership of the site’s quality operations.

You’ll lead day-to-day QA activities, manage a small quality team, and ensure ongoing compliance with regulatory requirements. This hybrid role offers both strategic and hands-on responsibilities in a high-impact environment.

Key Responsibilities

• Act as Qualified Person (QP) for batch release of sterile pharmaceutical products
• Lead and mentor two QA Associates to ensure efficient and compliant operations
• Oversee QA processes, including deviation handling, CAPA, change control, and QMS updates
• Ensure site-wide GMP compliance and support audit readiness activities
• Represent QA during external inspections and audits (approximately 4–5 per year)
• Collaborate cross-functionally with manufacturing, supply chain, and regulatory teams

Required Qualifications

• Current eligibility to act as a Qualified Person (QP) in the UK
• 3–4 years of active QP experience
• Strong background in quality assurance within a GMP-regulated environment
• Experience in sterile manufacturing is essential
• Solid understanding of QMS, batch documentation, and regulatory requirements
• Prior experience managing or mentoring junior QA team members
• Ability to work on-site three days per week as part of a hybrid model

Preferred Qualifications

• Familiarity with MHRA and EMA regulatory expectations
• Experience representing QA during external audits or inspections
• Exposure to sterile fill/finish operations or aseptic processes
• Strong communication, leadership, and problem-solving skills

Additional Information

• Hybrid working model: minimum 3 days per week on-site
• Start date: ASAP (ideally within the next couple of months)

This is an excellent opportunity to lead quality operations in a dynamic and fast-paced sterile manufacturing environment. If you’re a Qualified Person ready for the next step in your career, apply today!

Seniority level

• Seniority level
• Mid-Senior level

Employment type

• Employment type
• Full-time

Job function

• Job function
• Quality Assurance and Manufacturing
• Industries
• Pharmaceutical Manufacturing and Biotechnology Research

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