Director, Design Assurance
Director, Design Assurance
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Job 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 peoples 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. Were 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. Youll collaborate with cross-functional teams to ensure our processes meet regulatory requirements. Were 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:
- - Bachelors 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 well 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 were 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 or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
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 UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
Employment Type
Full-Time
Key Skills
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