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Job summary

Main area
QC Lab
Grade
NHS AfC: Band 7
Contract
Permanent
Hours
Full time - 37.5 hours per week (Monday to Friday)
Job ref
345-PHA7311839
Employer
North Tees and Hartlepool NHS Foundation Trust
Employer type
NHS
Site
North Tees
Town
Stockton on Tees
Salary
£46,148 - £52,809 pro rata per annum
Salary period
Yearly
Closing
03/08/2025 23:59

Employer heading

North Tees and Hartlepool NHS Foundation Trust logo

Head of Quality Management & Validation (SQCL)

NHS AfC: Band 7

At North Tees & Hartlepool NHS Foundation Trust, our main priority is, and always will be, providing safe and high quality care to our patients every day; the kind of care we would want for ourselves and our loved ones.

If you share our passion then apply for this opportunity and help us make our patients’ experience the best it can possibly be.

North Tees and Hartlepool NHS Foundation Trust provides hospital-based services to the population of Hartlepool, Stockton on Tees and parts of East Durham and Sedgefield as well as community, therapeutic and screening to a wider population across Durham and Teesside.

Job overview

Advert may close once sufficient number of applications is reached

At University Hospital Tees we have high ambitions and as a Group we are committed to delivering more together for the populations we serve. This is an exciting opportunity for an experienced Quality leader to take ownership of our Stockton QC Laboratory’s Quality Management System (QMS) and Validation function. As Head of Quality Management & Validation you will shape and drive our pharmaceutical quality strategy, ensuring full compliance with UK & EU GMP and other regulatory requirements. You’ll build and sustain a robust QMS—designing, maintaining and continually improving processes, KPI frameworks and audit programmes—while overseeing the Validation Master Plan across facilities, equipment and processes. In this pivotal role, you’ll report quality performance to senior management, coordinate internal and external audits, and steer targeted R&D initiatives in partnership with our lead pharmacist for Quality. You will also inspire, mentor and develop a high-calibre team of QA and Validation professionals, and work closely with cross-functional stakeholders to weave quality into every aspect of the business.

Main duties of the job

 The Head of Quality Management & Validation leads and owns the design, implementation and continual improvement of the organisation’s Quality Management System (QMS) and Validation Governance to ensure full compliance with UK MHRA and EU GMP requirements 

Working for our organisation

At North Tees & Hartlepool NHS Foundation Trust our main priority is, and always will be, to provide safe and high quality care to our patients every day; the kind of care we would want for ourselves and our loved ones. We want our organisation to be the best place to work with the right staff, in the right roles, at the right time, to ensure we deliver exceptional patient care and experience.

We are an Active Hospital and strongly encourage participation of all staff and patients.  We expect MECC for all our people interactions.

We will support staff through providing an inclusive and supportive workplace with health and well-being initiatives, staff benefits and opportunities for personal and professional development.  Staff recognition is very important to us; as well as performance reviews and appraisals, we recognise staff through Star and Team of the month, colleague recognition – a note of thanks, Managers Awards, Shining Stars and Service Awards.

We recruit for values and “Together we are North Tees & Hartlepool”

Detailed job description and main responsibilities

The design, maintenance and effectiveness of the Stockton Quality Control  Laboratory’s pharmaceutical quality management system (QMS),  in compliance with UK & EU Good Manufacturing Practice

Developing and monitoring quality performance indicators (KPIs) and prepare regular reports for senior management. 

Designing and implementing an appropriate internal audit programme and coordinate external audits to assess QMS effectiveness 

Leading on specific research and development activities of the laboratory as directed by the lead pharmacist for Quality.

The design, maintenance and effectiveness of the Validation Master Plan in accordance with GMP and other regulatory requirements. 

 Coordinating, reviewing and approving validation activities related to facility, equipment and processes with EU GMP, MHRA, and other applicable regulatory standards. 

Leading, mentoring, and developing a team of quality assurance and validation professionals.

Participating in cross-functional meetings to integrate quality strategies with business objectives.

Person specification

Qualifications

Essential criteria
  • degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering or a closely related discipline.
Desirable criteria
  • MSc in Microbiology or Quality Management (eg PTQA)

Knowledge

Essential criteria
  • In depth knowledge of GMP and Validation
  • Experience in designing, implementing and maintaining pharmaceutical Quality Management Systems in a QC or manufacturing environment
  • Proven track record owning a Validation Master Plan, including equipment/facility/process qualification and re-qualification
  • Demonstrable experience planning and executing internal audit programmes, plus coordinating MHRA or other external inspections.

leadership and communication

Essential criteria
  • History of building, mentoring and leading a high-performing QA/Validation team.
  • Ability to communicate effectively to a range of professionals with conflicting priorities
  • Ability to influence and train others

Experience

Essential criteria
  • Apply personal effectiveness skills in terms of time management, prioritisation, resource management, self-motivation and team work
  • Experience of working in a GMP regulated environment
  • Experience of developing cost effective methods and validating methods
Desirable criteria
  • Extensive experience in microbiological quality control
  • Extensive experience in an MHRA inspected laboratory
  • Experience of writing up scientific data for publication

Employer certification / accreditation badges

Veteran AwareApprenticeships logoNo smoking policyPositive about disabled peopleAge positiveDisability confident leaderDefence Employer Recognition Scheme (ERS) - SilverMindful employer.  Being positive about mental health.Dying to Work CharterStep into healthArmed Forces Covenant

Documents to download

Apply online now

Further details / informal visits contact

Name
Marco Picone
Job title
Lead Aseptic Pharmacist & SQCL Quality Assurance
Email address
[email protected]
Telephone number
01642624358
Additional information

For further info contact Marco Picone on 01642 624358

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