At a Glance
- Tasks: Lead quality compliance initiatives and ensure adherence to regulatory standards in a dynamic pharmaceutical environment.
- Company: Join GSK, a global leader in healthcare committed to improving patient health.
- Benefits: Competitive salary, career development opportunities, and a supportive work culture.
- Other info: On-site role in Hertfordshire with a focus on teamwork and leadership.
- Why this job: Make a real impact on global health while driving quality excellence.
- Qualifications: Bachelor's degree in a scientific field and significant experience in quality compliance.
The predicted salary is between 80000 - 100000 £ per year.
GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.
The Quality Compliance Director is accountable for leading and overseeing the site Quality Compliance function, ensuring sustained adherence to regulatory requirements, GxP standards, and the Quality Management System (QMS). The role drives proactive compliance strategies and continuous improvement initiatives to maintain a high state of inspection readiness, including for Pre‑Approval Inspections (PAIs). The position provides quality governance across the product lifecycle, including Quality Council leadership, oversight of suppliers and third parties, complaints management, documentation control, and Periodic Product Reviews. Acting as a key interface with internal and external stakeholders — including regulatory authorities — the Quality Compliance Director plays a critical role in safeguarding and strengthening GSK's reputation for excellence in quality and compliance. The Quality Compliance Director reports to the Site Quality Director and is a core member of the site Quality Leadership Team (QLT).
Key Responsibilities
- Act as the primary interface for regulatory inspections (Pre‑Approval Inspections (PAI) and routine inspections) and audits, ensuring inspection readiness.
- Manage and host the regulatory inspections, including preparation, execution, and follow‑up on corrective and preventive actions (CAPAs).
- Ensure compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) across all areas.
- Monitor evolving regulatory requirements (e.g., FDA, EMA, MHRA, WHO) and ensure timely updates to quality systems and processes.
- Accountable for working with Senior Leadership Team (SLT) to grow capability in understanding regulatory changes, associated risks and identifying appropriate CAPA.
- Lead and perform internal and external audit programs, including vendors and suppliers' audits, to assess compliance with GSK standards and regulatory expectations.
- Accountable to develop and maintain the Supplier Management Process.
- Accountable for document system management and oversight.
- Accountable for the Quality Council process.
- Ensure the Quality Council process effectively drives improvements and compliance on site.
- Responsible for managing site Quality governance processes and compliance activities including Periodic Product Reviews, Internal Quality Audits (IQA) / Data Review Assessments (DRAs), compliance metrics, Quality Regulatory Intelligence, Stability, Supplier Quality management and Complaints oversight.
- Manage Quality Risk Model (QRM), review trends for all risk elements and identify improvement actions.
- Drive continuous improvement initiatives across quality systems, processes, and culture to enhance compliance and operational efficiency.
- The role ensures Quality product life cycle management and medical device compliance.
Basic Qualifications
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Physical Sciences, or a related scientific discipline; advanced degree preferred.
- Significant experience within commercial pharmaceutical manufacturing environments, with strong exposure to GMP‑regulated operations and quality systems.
- Demonstrated expertise in Product Lifecycle Compliance Management, including oversight of compliance strategies across product development, commercialization, and post‑market activities.
- Proven experience leading Quality Compliance programs, including deviation management, CAPA effectiveness, audit readiness, inspection support, risk management, and continuous improvement initiatives.
- Deep working knowledge of global regulatory and compliance requirements, including current Good Manufacturing Practices (cGMP), U.S. FDA regulations, ICH Guidelines (Q8, Q9, Q10, Q11), WHO standards, EudraLex, EEU regulations, and other international/Rest‑of‑World requirements.
- Strong leadership experience managing and developing high‑performing quality or compliance teams (approximately 68 direct reports), with a demonstrated ability to set clear priorities, drive accountability, develop talent, and lead through change and ambiguity.
Preferred Qualifications
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence across multidisciplinary functions including Operations, Engineering, Validation, Supply Chain, Production, QC, Finance, and EHS.
- Strong decision‑making and prioritization skills, with the ability to perform effectively under pressure and manage competing business‑critical priorities.
- Proven success leading change management initiatives within complex pharmaceutical or highly regulated environments.
- Strong analytical and strategic problem‑solving capabilities, with the ability to leverage data and metrics to support risk‑based decisions and continuous improvement.
- Highly adaptable and collaborative leadership style, with demonstrated success working across global, diverse, and cross‑functional teams.
Work Arrangements
This role offers an on‑site (weekly 5 days) working model at Ware, Hertfordshire, UK. Remote or fully home‑working arrangements are not available for this role.
Closing Date for Applications
24th May 2026 EOD
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. If you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at UKRecruitment.Adjustments@gsk.com.
Quality Compliance Director in Ware employer: WISE Campaign
GSK is an exceptional employer, offering a dynamic work environment in Ware, Hertfordshire, where the Quality Compliance Director will play a pivotal role in ensuring regulatory excellence and driving continuous improvement. With a strong commitment to employee development, GSK provides ample opportunities for growth within a collaborative culture that values diversity and innovation. Employees benefit from a robust support system, competitive compensation, and the chance to contribute to meaningful healthcare advancements that impact millions globally.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance Director in Ware
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you stand out and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice common interview questions and have your own questions ready. This shows you're engaged and gives you a chance to assess if the role is right for you too. Remember, it’s a two-way street!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Quality Compliance Director in Ware
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in quality compliance and regulatory standards. We want to see how your background aligns with the role of Quality Compliance Director, so don’t hold back on showcasing your relevant skills!
Showcase Your Achievements:When detailing your past roles, focus on specific achievements that demonstrate your expertise in managing compliance and quality systems. Use metrics where possible to illustrate your impact – numbers speak volumes!
Be Clear and Concise:Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly grasp your qualifications and fit for the role.
Apply Through Our Website:We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and allows us to process it efficiently. Plus, you’ll find all the details you need there!
How to prepare for a job interview at WISE Campaign
✨Know Your Regulations
Make sure you brush up on the latest regulatory requirements like cGMP and GLP. Being able to discuss how these impact quality compliance will show that you're not just familiar with the standards, but that you can apply them effectively in a real-world setting.
✨Showcase Your Leadership Skills
As a Quality Compliance Director, you'll be leading teams and driving initiatives. Prepare examples of how you've successfully managed high-performing teams and led change in previous roles. This will demonstrate your capability to handle the responsibilities of the position.
✨Prepare for Inspection Scenarios
Think about potential inspection scenarios and how you would manage them. Be ready to discuss your experience with audits and inspections, including how you prepared for them and followed up on corrective actions. This will highlight your proactive approach to compliance.
✨Engage with Stakeholders
Since this role involves interfacing with various stakeholders, practice articulating how you would communicate and influence across different functions. Share specific instances where you've successfully collaborated with multidisciplinary teams to achieve compliance goals.
