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Site Validation Manager

As Site Validation Manager you will have the ability to influence guidance that will shape future approaches for GSK. This involve driving strategies, embedding solutions and CI framework for all validation activities. You will have exposure to work with all functions across the Ware site, whilst managing your own small team.

Job Purpose

To provide SME advice for, set direction and manage all Validation activities across the site.

To manage the team responsible for maintaining qualification and validation status on site, as per regulatory guidance, of manufacturing premises, utilities, equipment, computerised systems and processes.

To provide overall management of quality validation activities, supporting business goals by:

• Defining standards and procedures for validation activities.
• Ensuring consistent and cost-effective standards are applied.
• Ensuring adequate management of resources to meet business needs and site goals.
• Providing guidance and expert advice.

Ensuring qualification and validation processes are continuously revisited in light of regulations and through cycles of continuous improvement.

In this role you will…

• Liaise with Manufacturing, Technical and Quality Assurance Directors in order to agree best practices, policies and procedures for the company and site.
• Set the Validation standards for the site, including authorship and/or review and approval of Site Validation Master Plan. Approval of validation plans and reports relating to site projects (or delegated to appropriately trained staff).
• Maintain a programme that ensures validation status is regularly reviewed and updated as required in line with changes in business and regulatory requirements.
• Manage a team of specialists and other direct reports that co-ordinate Validation activities on site in order to maintain a high standard of compliance with regulatory and company standards for Validation.

• Promote Validation and all aspects of Quality Assurance on the site to bring compliance and business benefits whilst ensuring alignment with site and departmental goals.
• Support validation activities for a new OSD facility and transfer of new products into the manufacturing value streams whilst promoting continuous improvements to processes requiring validation input.

Closing Date for Applications: Monday 4th September 2023

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.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Significant pharmaceutical experience, preferably across quality and technical/engineering functions.
• Excellent planning, organisational and time management skills along with an ability to make decisions, solve problems, negotiate, influence, and communicate with others as required.
• Ability to clearly communicate best practices with peer group in order to provide improvement and integration.

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Pharmaceutical Engineering experience
• Product Lifecycle, Control of Change and Quality Risk Management experience

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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 [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

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