Operational Quality Director
Operational Quality Director
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Job Description
Operational Quality Director
Location: Ware United Kingdom (Site based role)
To lead the Operational Quality functions on the Ware PSC site driving consistency and bestpractice across the value streams and promoting a culture of quality across the site.
Key Responsibilities include but are not limited to:
To provide strategic leadership of value stream Operational Quality leads including retention development and training.
To provide assurance that products released for sale have been manufactured and packaged according to the regulatory dossier GMP and business requirements through effective governance by OQ teams and implementation of appropriate quality processes.
To review batch documentation test results and all other documentation associated with certification and/or release of finished product.
Product certification and /or release of finished product.
Distribution Risk Assessments
To manage staff and other resources to ensure compliance and efficient performance and provide budgetary control of function. Shift based oversight of GMP/GDP activities including data integrity.
To act as the prime link of the relevant Operational Quality and Project teams to the QLT and SLT and to build collaborative relationships with both internal and 3rd party customers (where appropriate).
To ensure significant quality investigations are managed appropriately and effectively. Assess and approve deviation records associated corrective and preventative actions (CAPA) effectiveness and deviation trending.
Establish and track a series of stretching measurable improvement processes and metrics to manage performance and drive improvement. Drive quality improvement initiatives in conjunction with stakeholders on the site.
To promote quality and compliance through monitoring of quality related systems effective process design and implementation of improvements.
Ensure resource management processes are in place to deliver all required activities and process in place to review expected workload versus resource on a 024 month timeline.
To build relationships with MHRA and FDA and other regulatory authorities as appropriate. To influence the sites response to regulatory changes. To have detailed knowledge of cGMP within the major markets
Lead and support level 2/3/4 audits across the site.
Why you
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Experience of effectively leading and managing technical professional teams
Ability to deliver communication with clarity impact and tailored to audience.
Experienced in handling regulatory interfaces such as inspections
Knowledge and application of the principles of a Quality Management System (QMS)
Knowledge of current Good Manufacturing Practice requirements within major pharmaceutical markets
Knowledge of change management processes
Sees issues through the eyes of others even when views conflict with own
Able to raise levels of performance by establishing an improvement process or setting specific measurable targets and goals linked to GSK business needs.
Preferred Qualifications:
If you have the following characteristics it would be a plus:
Graduate level (or equivalent) qualification in a scientific discipline
Preferably a QP Qualification
Proven ability to communicate and influence at multiple levels of management
Closing Date for Applications: 20th May 2025 (COB)
We create a place where people can grow be their best be safe and feel welcome valued and included. We offer a competitive salary an annual bonus based on company performance healthcare and wellbeing programmes pension plan membership and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model empowering you to find the optimal balance between remote and inoffice work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK
Please take a copy of the Job Description as this will not be available post closure of the applying for this role please use the cover letter of the online application or your CV to describe how you meet the competencies for this role as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
#LIOnSite
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive
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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
Employment Type
Full-Time
Key Skills
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