Site Validation Manager

Hertfordshire, United Kingdom

Job Description


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

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\xe2\x80\xa6
  • 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 , as this will not be available post closure of the advert.

When applying for this role, please use the \xe2\x80\x98cover letter\xe2\x80\x99 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 \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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\xe2\x80\x99s 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\xe2\x80\x99re 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 or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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 GSK\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting site.

GlaxoSmithKline

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Job Detail

  • Job Id
    JD2991717
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hertfordshire, United Kingdom
  • Education
    Not mentioned