Quality Manager Medical Device jobs

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Job title: RCI & CAPA Senior Manager
Location: GSK HQ, London
Contract Type: Inside IR35

Overview

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Role Overview

The RCI & CAPA Senior Manager will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development and related functions. This person will work closely with quality, safety, clinical and regulatory to resolve complex issues and reduce future risk. We value clear thinkers who listen, influence with empathy, and drive practical, data-led solutions. This role offers visible impact, real career growth and the chance to shape processes that help us unite science, technology and talent to get ahead of disease together.

Key Responsibilities

• Lead end-to-end root cause investigations for cross-functional and high-risk issues, using structured methods to reach evidence-based conclusions.
• Coach and support colleagues on investigation tools, risk assessment and SMART CAPA design.
• Oversees the CAPA closure and effectiveness implementation.
• Partner with process owners and stakeholders to simplify workflows, reduce recurrence and improve issue management practices.
• Facilitate the management review and oversight by proactively monitoring signals and business performance.
• Assess Issues for criticality.

Required Skills & Qualifications

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

• Degree in a life science, engineering, quality, or related field, or equivalent experience.
• Significant experience in issue investigation, CAPA management, quality or risk roles within pharmaceutical, vaccines, or life sciences settings. With experience in GCP, GVP and/or GLP.
• Demonstrated experience leading root cause analyses and implementing CAPAs in a regulated environment.
• Strong knowledge of quality management systems and applicable regulatory expectations.
• Proven ability to influence across a matrix organisation and lead cross-functional teams.
• Comfortable working in a hybrid model, with an expectation to be on-site regularly.

Essential Skills & Qualifications

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced degree (MSc, PhD or equivalent) in a relevant discipline.
• Formal training or certification in root cause analysis, Six Sigma, Lean or similar methodologies.
• Experience supporting regulatory inspections or preparing for audits.
• Experience of assessing Issues for criticality and Serious Breaches.
• Track record of process improvement and measurable impact through CAPA effectiveness.
• Experience working with digital tools for quality management, analytics or workflow tracking.
• Familiarity with global regulatory frameworks and guidance relevant to clinical and quality activities.

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.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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