At a Glance
- Tasks: Lead a team ensuring quality and compliance in manufacturing processes.
- Company: Join GSK, a global biopharma leader dedicated to improving health.
- Benefits: Enjoy competitive salary, bonuses, training opportunities, and healthcare support.
- Other info: Dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact on patient safety and product quality.
- Qualifications: Degree in Science or Engineering and leadership experience required.
The predicted salary is between 60000 - 75000 £ per year.
At the GSK Barnard Castle Manufacturing Site, the Quality function ensures quality and regulatory compliance across the entire product lifecycle within manufacturing and production operations. Quality is central to guaranteeing our medicines meet the highest standards of safety and efficacy. As a member of this team you will help uphold our commitment to delivering safe, effective and compliant products to patients and consumers worldwide.
About Barnard Castle: GSK Barnard Castle is a key secondary manufacturing site. We have invested heavily in industry 4.0 state of the art bespoke equipment to support sustained new product introductions and volume increases. As a key supplier of some of GSK’s blockbuster products the site contributes revenues of ~$2Bn annually.
Job Purpose: As Quality Validation and CSV Manager you will manage a team responsible for quality and validation activities, including process and cleaning validation, equipment qualification, facility validation, and Computer Systems Validation (CSV). This role ensures all validation operations comply with regulatory requirements, GSK quality standards (Quality Management System - QMS), and industry best practice.
Direct Reports – The role manages approximately 9 to 12 direct reports.
Key Responsibilities (include):
- Manage the planning, execution, and maintenance of validation activities (including process, cleaning, facility, and Computer Systems Validation, and equipment qualification).
- Ensure validation activities comply with regulatory expectations, GSK quality standards (QMS), and industry best practices (maintaining audit readiness at all times).
- Provide technical expertise for validation and CSV processes.
- Collaborate with cross-functional teams (including Engineering, Manufacturing, IT, and Quality teams) to ensure validation activities align with project timelines and business objectives.
- Develop, review, and approve validation protocols, reports, and associated documentation, ensuring accuracy, compliance, and adherence to validation requirements.
- Manage the validation lifecycle for computer systems (including planning, testing, installation qualification, operational qualification, and performance qualification - IQ/OQ/PQ).
- Represent validation activities for internal and external audits, presenting validation strategies and documentation to regulators and auditors (to ensure successful outcomes).
- Support the adoption of new technologies, methods, and equipment by ensuring validation requirements are integrated seamlessly into development and implementation plans.
- Provide training, development, mentoring, and coaching to team members and stakeholders to build site-wide understanding and capability in validation and CSV practices.
About You: As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self‑motivated person who has strong experience of managing a team in a complex, highly‑regulated manufacturing site. People management skills / experience is a pre-requisite for delivery in the role. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset and apply agile thinking and ways of working—iterative problem solving, adaptive planning and prioritisation—to accelerate improvements across cross‑functional teams, whilst maintaining regulatory and quality compliance. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.
Basic Qualifications:
- Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a manufacturing facility within a highly-regulated industry).
- Relevant knowledge/experience within Validation and CSV.
- Leadership experience.
- Knowledge of current Good Manufacturing Practice (cGMP) requirements.
- Knowledge and application of Quality Management Systems (QMS).
- Knowledge of internal and external audit processes (eg; inspection readiness).
Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to:
- Competitive base Salary
- Annual bonus based on company performance
- Opportunities to partake in on the job training courses
- Opportunities to attend and partake in industry conferences
- Opportunities for support for professional development and chartership
- Access to healthcare and wellbeing programmes
- Employee recognition programmes
Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
Quality Validation and CSV Manager in Barnard Castle employer: GlaxoSmithKline
GSK Barnard Castle is an exceptional employer, offering a dynamic work environment where innovation meets quality in the biopharmaceutical industry. With a strong commitment to employee development, competitive benefits, and a culture that prioritises patient impact, GSK fosters a collaborative atmosphere that empowers team members to thrive and contribute meaningfully to global health. The site’s investment in state-of-the-art technology and its role in producing blockbuster products further enhance the unique advantages of working here, making it an ideal place for professionals seeking growth and purpose in their careers.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Validation and CSV Manager in Barnard Castle
✨Tip Number 1
Network like a pro! Reach out to current or former employees at GSK, especially those in quality roles. A friendly chat can give you insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of validation processes and regulatory compliance. We want to see you shine with your expertise, so practice explaining complex concepts in simple terms.
✨Tip Number 3
Show off your leadership skills! Be ready to discuss how you've managed teams in the past, especially in high-pressure situations. We love candidates who can inspire and guide others.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the GSK family.
We think you need these skills to ace Quality Validation and CSV Manager in Barnard Castle
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Quality Validation and CSV Manager role. Highlight your relevant experience in validation and compliance, and show us how your skills align with our needs at GSK.
Showcase Your Leadership Skills:Since this role involves managing a team, don’t forget to emphasise your leadership experience. Share examples of how you've successfully led teams in a regulated environment and how you’ve driven performance improvements.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon where possible. We want to see your qualifications and experiences without having to sift through unnecessary fluff!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to the right people. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at GlaxoSmithKline
✨Know Your Stuff
Make sure you brush up on your knowledge of Quality Management Systems (QMS) and current Good Manufacturing Practice (cGMP). Be ready to discuss how these apply to validation activities, as well as any relevant experience you have in a highly-regulated manufacturing environment.
✨Showcase Your Leadership Skills
As a Quality Validation and CSV Manager, you'll be managing a team. Prepare examples of how you've successfully led teams in the past, focusing on your people management skills and how you've influenced others to achieve objectives. This will demonstrate your capability to handle the responsibilities of the role.
✨Be Audit-Ready
Familiarise yourself with internal and external audit processes. Be prepared to discuss how you've maintained audit readiness in previous roles and what strategies you would implement to ensure compliance with regulatory expectations at GSK.
✨Communicate Effectively
Strong written and verbal communication skills are essential for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex validation processes. Consider preparing a few key points about how you would present validation strategies to regulators and auditors.
