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Senior Director, Global Quality Systems & Integration

Care Access
4 months ago
Full-time
On-site
Unknown

About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com. How This Role Makes a Difference The Senior Director of Global Quality Systems & Integration supports the design, governance, and advancement of the organisation’s global Quality Management System (QMS), ensuring it scales effectively with international growth. This role provides strategic and operational leadership across regions, promotes global quality consistency, and oversees the integration of newly acquired international businesses into a unified quality and operational model. This position enhances organisational maturity, mitigates quality and regulatory risks, and ensures compliance with applicable regulatory requirements across global jurisdictions. How You'll Make An Impact Strategy and Leadership Contribute to the development of the global quality strategy and translate strategic objectives into actionable regional and functional plans. Provide informed guidance to senior leadership on quality risks, organisational readiness, and integration considerations. Foster alignment across regions and functions by influencing stakeholders and driving adoption of quality priorities and initiatives. Lead cross-functional groups to ensure quality considerations are embedded in global programmes, operations, and expansion activities. Global Quality Management System (QMS) Lead the development, enhancement, and operational governance of the global QMS, ensuring it remains scalable and adaptable to organisational growth. Maintain alignment of QMS standards with international regulatory requirements (ICH GCP, ISO 9001, CFR, EU CTR, UK SI, and relevant local frameworks). Implement global quality policies, procedures, and documentation standards to ensure consistent practices across regions. Oversee regional adoption and effectiveness of QMS components, partnering with leaders to resolve systemic issues and drive harmonisation. International Integration Direct quality integration activities for acquired companies and new international sites, ensuring timely and structured alignment with global expectations. Assess inherited systems, processes, and documentation to determine integration needs and maturity gaps. Oversee transition plans that harmonise quality culture, processes, and compliance standards across the global footprint. Collaborate with Operations, Regulatory, HR, IT, and Change Management teams to support smooth integration and sustained adoption. Compliance and Regulatory Oversight Ensure organisational readiness for regulatory inspections, sponsor audits, and customer audits, coordinating regional and global teams. Maintain oversight of compliance performance across regions and ensure consistent application of global standards. Monitor regulatory updates and emerging requirements, advising on process or system adjustments needed to maintain compliance. Guide teams in implementing effective CAPAs, ensuring timely closure and verification of global compliance issues. Continuous Improvement Lead global continuous improvement initiatives aimed at enhancing process efficiency, reducing quality risks, and strengthening data integrity. Apply structured problem-solving methodologies (e.g., RCA, CAPA, Lean) to address systemic issues and drive operational excellence. Promote best practices across regions and facilitate cross-functional and cross-country learning. Support development of a culture that embraces accountability, quality ownership, and proactive improvement. Metrics, Reporting & Governance Define and report on global quality metrics that measure system performance, risk indicators, and improvement progress. Provide data-driven insights to senior leadership to inform risk mitigation, resource prioritisation, and strategic decision-making. Manage global quality governance forums to ensure consistent oversight, issue escalation, and cross-functional accountability. Ensure accurate and timely global reporting, enabling transparency and alignment across regions. The Expertise Required Expert business knowledge with a comprehensive understanding of the organization and functional areas. Comfortable developing and implementing company-wide policies and practices impacting multiple functions. Experience assessing, identifying, and providing strategic directions to support with complex situations impacting multiple departments often working cross-functionally. Establishes and develops short-term departmental strategy and translates into multi-functional objectives. Comfortable interacting with and advising internal and external executive level management. Certifications/Licenses, Education, and Experience Prior leadership experience managing multiple teams/functions. Strong preference for candidates with experience in healthcare and/or clinical trials industry. Typically requires 8 – 10 years of relevant experience. How We Work Together Location: Remote within the United Kingdom. This role requires 100% of work to be performed in a remote office environment. Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com