Compliance Specialist

GSK; Irvine; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading biopharma company in Irvine seeks a Compliance Specialist to ensure compliance with regulatory and quality standards. Responsibilities include managing audits, supporting continuous improvement initiatives, and promoting a compliance-focused culture. The ideal candidate should have a degree in a relevant field and experience in audits and GMP. Competitive compensation and the chance to impact patient care are offered.

Qualifications

• Experience in internal or external audits.
• Strong knowledge of GMP and Quality Management Systems.
• Demonstrated ability to influence stakeholders.

Responsibilities

• Ensure site compliance with Good Manufacturing Practices (GMP).
• Manage internal audit programs for inspection readiness.
• Lead QMS updates and provide training.

Skills

Attention to detail

Proactive problem solving

Excellent communication

Organizational skills

Education

Bachelor’s degree in a relevant science or engineering field

Job description

Overview

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

This role is an exciting opportunity to make a meaningful impact on GSK’s compliance culture. As a Compliance Specialist, you will ensure the site meets regulatory, licensing, and quality standards. You’ll collaborate across teams to drive audit readiness, manage quality processes, and support continuous improvement. We value candidates who are detail-oriented, proactive, and passionate about fostering a culture of compliance and excellence.

Responsibilities

• Ensure the site complies with Good Manufacturing Practices (GMP), GSK Quality Management Systems, and regulatory requirements.
• Manage internal Level 1 audit programs ensuring inspection readiness.
• Facilitate and chair local inspection readiness forum
• Verify corrective and preventive actions (CAPA) to ensure they are effective and sustainable.
• Lead the implementation of Quality Management System (QMS) updates, providing training and coaching to site personnel.
• Own and manage the site change control process for quality-impacting changes, tracking performance and communicating progress.
• Promote a compliance-focused culture through mentoring, training, and continuous improvement initiatives.
• Chair the GMP change management meetings.

Qualifications/Skills

Basic Qualifications:

• Bachelor’s degree in a relevant science or engineering field, or equivalent experience in pharmaceutical manufacturing.
• Experience in internal or external audits and resolving compliance issues.
• Strong knowledge of GMP and Quality Management Systems.
• Excellent communication, organizational, and coaching skills.
• Proven ability to influence stakeholders and drive results across cross-functional teams.
• Demonstrated experience in managing tasks and projects effectively to meet tight deadlines.

Preferred Qualifications:

• Experience as a trained auditor at Level 1 or Level 2.
• Familiarity with Quality Documentation systems.
• Proven ability to influence and lead teams in a matrix environment.
• Knowledge of regulatory requirements across global markets.

Closing Date

Closing Date for Applications – 8th October 2025 (COB).

Join us in shaping a culture of compliance and innovation at GSK. Together, we’ll make a difference.

Why GSK?

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

We are committed to providing an environment where our people can thrive and focus on what matters most. Our culture is built on being ambitious for patients, accountable for impact and doing the right thing as the foundation for delivering for patients, shareholders and our people.

Equal Opportunity

GSK is an Equal Opportunity Employer. This means 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 opportunities with our hiring team.

Adjustments

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday; hours may vary on bank holidays.

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.

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