Senior Risk Management Engineer

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 120,000 - 170,000; Full time

Job summary

GlaxoSmithKline is seeking a Senior Risk Management Engineer to lead device risk across PDDS, ensuring RMF ownership and regulatory readiness. Hybrid work with US on-site presence at Upper Providence.

The role requires strong experience in ISO14971 methodologies (FMEA/FTA), cross-functional teamwork, and risk-based decision making across medical devices and drug-device combos.

Qualifications

• Bachelor's degree or equivalent in Engineering, Science or Risk Management.
• Experience in risk management within regulated manufacturing or life sciences.
• FMEA/FTA or ISO14971 risk methodologies experience.

Responsibilities

• Serve as PDDS risk owner for device programmes, owning RMF.
• Design and maintain risk frameworks, tools and documentation.
• Run failure mode analysis, hazard assessments and root cause investigations.
• Lead cross-functional risk assessment workshops with multiple stakeholders.
• Support regulatory readiness with risk rationales and evidence.
• Coach teams in risk thinking and best practices.

Skills

FMEA

FTA

ISO14971

Communication

Regulatory awareness

Risk management

Education

Degree in Engineering

IRCA CQE

Job description

Senior Risk Management Engineer

Closing Date: 25th September 2026 (COB)

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Position Summary

The Device Risk Management Lead is accountable for establishing, executing, and continuously improving risk management for medical devices and drug-device combination products across PDDS, in accordance with ISO 14971 and applicable global regulations (e.g. EU MDR 2017/745, FDA 21 CFR 820). The role provides subject-matter expertise in device risk management, owns key risk files and processes, and ensures that risk controls are appropriately identified, implemented, and verified to support safe and effective products throughout the lifecycle.

Responsibilities

• Serve as PDDS risk owner for designated device and combination product programmes, owning the Risk Management File (RMF) and leading risk assessments (e.g. Design Risk Assessment, Use Risk Assessment, Process/Manufacturing risk assessments).
• Design and maintain risk frameworks, tools and documentation to support consistent decision making.
• Run failure mode analysis, hazard assessments and root cause investigations with cross-functional teams.
• Lead cross-functional risk assessment workshops with Human Factors, Device Engineering, Formulation, Primary Packaging, Clinical, Safety, Regulatory, Quality and Manufacturing stakeholders to identify hazards, hazardous situations, foreseeable misuse and associated harms.
• Support regulatory and audit readiness by preparing risk rationales and evidence for inspections.
• Coach and uplift site and project teams in risk thinking, tools and best practice.

Why You?

Basic Qualification

• Degree in Engineering, Science, Risk Management, or a related discipline, or equivalent experience.
• Strong experience in risk management or reliability roles within regulated manufacturing or life sciences.
• Practical experience with ISO14971 risk methodologies such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) or similar.
• Strong collaborator with experience working alongside engineering, quality, operations and procurement teams.
• Clear written and verbal communication skills, able to present complex issues simply to different audiences.

Preferred Qualification

• Experience in pharmaceutical or medical device environments with good understanding of GMP expectations.
• Formal risk or quality qualifications (for example IRCA, CQE, or equivalent training).
• Familiarity with regulatory risk expectations and inspection interactions.
• Comfortable using digital tools for data analysis, risk tracking and reporting.
• Experience coaching teams and embedding risk-led cultures across sites.
• Strong analytical and structured problem-solving skills with the ability to synthesise technical and clinical information into clear risk assessments.

Working Arrangement

This role is hybrid, with regular on-site presence required in the United Kingdom at our Ware RD site or in the US at our Upper Providence site.

What we offer

You will join a team that cares about safety, quality and the people who deliver them. You will have access to learning, mentorship and stretch opportunities. You will be part of meaningful work that connects science and technology to improve health.

Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call.

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 Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/