Operational Quality Director

TN United Kingdom; Ware; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Operational Quality Director to lead quality functions at their Ware site. This pivotal role involves driving best practices, ensuring compliance with regulatory standards, and fostering a culture of quality across the organization. The ideal candidate will have extensive experience in managing technical teams, a strong understanding of Good Manufacturing Practices, and the ability to influence at multiple management levels. Join a forward-thinking company dedicated to innovation and quality in the biopharma sector, where your leadership will make a significant impact on product excellence and safety.

Benefits

Annual bonus based on company performance

Healthcare and wellbeing programmes

Pension plan membership

Shares and savings programme

Qualifications

• Proven experience in leading and managing technical teams effectively.
• Strong knowledge of regulatory interfaces and quality management systems.

Responsibilities

• Lead Operational Quality functions and ensure compliance with GMP.
• Manage quality investigations and establish measurable improvement metrics.

Skills

Leadership of technical teams

Regulatory compliance

Quality Management Systems (QMS)

Good Manufacturing Practice (GMP)

Change management

Communication skills

Education

Graduate level qualification in a scientific discipline

QP Qualification

Job description

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Job description
Site Name: UK - Hertfordshire - Ware
Posted Date: May 6 2025

Operational Quality Director

Location: Ware, United Kingdom (Site based role)

To lead the Operational Quality functions on the Ware PSC site, driving consistency and best-practice 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 0-24 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 in-office 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 advert.When 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.

#LI-OnSite

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, it’s 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 [emailprotected] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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