Job summary
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
About us
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"
Job description
Job responsibilities
The design, maintenance and effectiveness of the Stockton Quality Control Laboratorys 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.
Job description
Job responsibilities
The design, maintenance and effectiveness of the Stockton Quality Control Laboratorys 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
- degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering or a closely related discipline.
Desirable
- MSc in Microbiology or Quality Management (eg PTQA)
Knowledge
Essential
- 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
- 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
- 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
- Extensive experience in microbiological quality control
- Extensive experience in an MHRA inspected laboratory
- Experience of writing up scientific data for publication
Person Specification
Qualifications
Essential
- degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering or a closely related discipline.
Desirable
- MSc in Microbiology or Quality Management (eg PTQA)
Knowledge
Essential
- 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
- 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
- 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
- Extensive experience in microbiological quality control
- Extensive experience in an MHRA inspected laboratory
- Experience of writing up scientific data for publication
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
