GSK
Overview
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’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
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. About 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. We are committed to creating an environment where our people can thrive and deliver for patients, shareholders and our communities. GSK is an Equal Opportunity Employer. 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. If you require adjustments to our process, contact us for accommodations. Important notice to Employment businesses/Agencies: GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site unless prior written authorization is obtained.
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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’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
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. About 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. We are committed to creating an environment where our people can thrive and deliver for patients, shareholders and our communities. GSK is an Equal Opportunity Employer. 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. If you require adjustments to our process, contact us for accommodations. Important notice to Employment businesses/Agencies: GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site unless prior written authorization is obtained.
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