Validation and Engineering Services QA Lead

Site Name: UK - Hertfordshire - Ware RD, UK - Hertfordshire - Stevenage
Posted Date: Mar 3 2025

Are you a Quality Assurance or Validation Professional seeking an opportunity to leverage and/or build upon your expertise in Quality Assurance and/or Validation (inclusive of equipment, utilities, facilities, computer systems, vendor management) working with internal and external business partners for R&D?

Do you enjoy a varied day dealing with challenges and answering the call for advice on different scenarios? If yes, the Validation and Engineering Services QA Lead role in Quality R&D Operations may be the right opportunity for you to explore.

This is a great opportunity where you will deal with various situations, which you will need to provide solutions for. Within QA you will be presented with issues and business proposals which you will be asked your advice to ensure quality and the patient is not affected while allowing us to grow and develop as a competitive business.

You will work cross functionally with different teams, gaining experience of providing key project management direction, pilot plant systems, medical devices, utilities and facilities.

This role can either be Validation focus or Engineering Services focus based on candidate's experience.

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

In this role you will perform the quality assurance activities and quality oversight of GMP Engineering Services activities (calibration, PM, Capital Project management, third party assessments etc.) and Scientific Services (Calibration, PM of Analytical Equipment) performed within UK Pharma R&D sites globally.

• Lead or support continuous improvement initiatives to align validation activities across Vx/Rx R&D Sites.
• Provide advice and consultancy to validation strategy for Capital Projects to ensure compliance with GSK GQP requirement, regulatory requirements and industry standards.
• Support gap assessments for new Global Quality Policy (GQP) or GQP revisions relating to System Qualification, Facility Design, Facility Operation, Compressed Gases, or Water/Steam.
• Provide quality oversight of R&D Engineering Services (RDES) and Scientific Services (SS) at multiple R&D GMP Sites, including:
• Review and approval GMP operational procedures (SOP or Work Instruction), Review and approval new equipment/instrument setup or change forms
  • Review and approval engineering change control
  • Support quality deviation investigation associated with service failures.
  • Support internal and external audits/assessments
  • Manage third party supplier assessment and vendor complaints for RDES external service providers.

Why you?
Essential Qualifications & Skills:

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

• Bachelor's degree in a science, engineering, or life sciences from an accredited university.
• Experiences in the pharmaceutical industry working to cGMP standards in Quality or Validation.
• Validation Experience with one of the three validation focuses: Facility/Utilities/Equipment, Computer System Validations, or Cleaning Validation.
• Experience in third party supplier assessment for engineering services.
• Experience with key Quality activities (i.e. Deviations, Customer complaints and Change Control, vendor complaints, vendor assessments)
• Strong interpersonal skills plus strong written and verbal communication skills.
• A good team player and able to work independently.

Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:

• Master's Degree in Pharmacy, Science, or an engineering discipline
• Good understanding of instrument calibration and equipment preventative maintenance programs
• Subject Matter Expert in the design and qualification of GMP utilities (HVAC, WFI, Clean Steam), Computer System or Cleaning Validation
• Familiarisation with Data Integrity principles (ALCOA+).
• Good analytical and problem-solving skills
• Experience of working with multi-functional teams with excellent organizational skills
• Strong interpersonal skills plus strong written and verbal communication skills.
• A good team player and able to work independently.

Closing Date for Applications - 17/03/2025 (COB)

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.

During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

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.

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 Ukdiversity.recruitment@gsk.com 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.

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 .

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.

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