Director, Design Assurance

GSK; Stevenage; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A global biopharma company in the UK is seeking a Director of Design Assurance to ensure compliance in managing human biospecimens. Responsibilities include leading design assurance activities, translating regulatory requirements, and driving process improvements. Candidates should have significant experience in governance and oversight within regulated environments. This role offers hybrid work flexibility and contributes to improving healthcare for 2.5 billion people by the decade's end.

Qualifications

• 10+ years in governance and oversight of human biospecimens in a regulated industry.
• Strong knowledge of relevant regulatory standards.
• Experience in medical devices or pharmaceutical development.

Responsibilities

• Lead design assurance activities related to human biospecimens.
• Translate regulatory expectations into compliance requirements.
• Collaborate with R&D teams on compliance integration.

Skills

Regulatory compliance

Cross-functional leadership

Problem-solving

Communication skills

Process improvement

Education

Bachelor's degree in engineering, life sciences, or related field

Advanced degree (e.g., MSc, PhD)

Job description

Overview

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 manage 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

• 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.
• 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.

About the role & company

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. We foster a culture ambitious for patients, accountable for impact, and committed to doing the right thing, focusing 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. 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. We are 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 focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. 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 is ambitious for patients, accountable for impact, and doing the right thing, which guides how 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, 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.

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 with 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