Head of Quality

JR United Kingdom; Newcastle upon Tyne; On-site; GBP 70,000 - 95,000; Full time

Job summary

A leading pharmaceutical organisation is seeking a Head of Quality in Newcastle. This senior role focuses on leading Quality Assurance and Compliance, ensuring regulatory adherence, and fostering a culture of quality excellence within a dynamic environment. The ideal candidate will have a strong background in QA/QC leadership, excellent stakeholder engagement skills, and be eligible for Qualified Person certification.

Qualifications

• Experience in a senior QA/QC role within the pharmaceutical industry or regulated environment.
• Knowledge of GMDP and regulatory compliance.
• Eligibility for nomination as a Qualified Person (QP).

Responsibilities

• Lead and manage Quality Assurance Systems and Quality Control teams.
• Drive site quality strategy and ensure compliance during audits.
• Oversee deviation investigations and champion staff development.

Skills

Leadership

Communication

Regulatory Compliance

Continuous Improvement

Education

Postgraduate qualification in a relevant scientific field

Job description

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Head of Quality, newcastle-upon-tyne, tyne and wear

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Client:

Darwin Recruitment

Location:

newcastle-upon-tyne, tyne and wear, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

06.06.2025

Expiry Date:

21.07.2025

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Job Description:

? Lead Quality Excellence - Head of Quality Opportunity in Pharma!?

Title: Head of Quality

Reporting To: Quality Director

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

• 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.
• Strategic thinker with the ability to manage competing priorities in a dynamic environment.
• Eligibility for nomination as a Qualified Person (QP).
• Postgraduate qualification in a relevant scientific field.
• Lean Six Sigma Green Belt or equivalent quality improvement certification

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.