Description

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 
Are you passionate about ensuring the highest standards in pharmaceutical development? As Director, Design Assurance, you will play a key role in driving operational compliance, standardization, and process improvement across our design processes, with primary focus on management of human biospecimens. You'll collaborate with cross-functional teams to ensure our processes meet regulatory requirements. We're looking for someone who thrives in a dynamic environment, values teamwork, and is committed to delivering excellence.

Responsibilities

• Lead design assurance activities related to management of human biospecimens to ensure compliance with regulatory standards and internal policies.
• Translate regulatory expectations of the Executive Order into actionable compliance requirements and managing audits from a Platform Science perspective.
• Define, document, and maintain processes for compliance with national security and data protection requirements.
• Collaborate with cross-functional R&D teams to integrate Executive Order-related controls into HBSM Written Standards, third-party contracts, and study protocols.
• Establish and conduct Management Monitoring assessments for new processes and maintain documentation and traceability to support external audit readiness, regulatory inquiries, and internal risk reviews.
• Drive continuous improvement initiatives to enhance design quality and efficiency.
• Provide leadership and guidance on design assurance best practices across the organization.
• Represent the department during audits and regulatory inspections related to management of human biospecimens.
• Support the Global Process Owner (GPO) to ensure appropriate governance and oversight is in place for management of human biospecimens

Qualifications/Skills

Basic Qualifications:

• - Bachelor's degree in engineering, life sciences, or a related field.
• - Significant experience (10+ years) in the governance, oversight, and compliance of human biospecimens within a regulated industry.
• - Strong knowledge of regulatory requirements and standards for HBSM (HTA, GCP, Biobanking, etc.).
• - Proven ability to lead cross-functional teams and manage complex projects.
• - Excellent communication and problem-solving skills.

Preferred Qualifications:

• - Advanced degree (e.g., MSc, PhD) in engineering, life sciences, or a related field.
• - Experience in medical devices or pharmaceutical product development.
• - Familiarity with risk management tools and methodologies 
• - Demonstrated success in driving process improvements and innovation.
• - Experience working in a global, matrixed organization.

Work Location:
This role is based in the United Kingdom and will require on-site presence with flexibility for hybrid working arrangements.

Join us in shaping the future of healthcare by ensuring the highest standards in design assurance. Together, we'll get ahead of disease and improve lives.

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 on [email protected] or 0808 234 4391.  The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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