Associate Director, Quality Management Systems

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact.

SUMMARY

The Associate Director, Quality Management Systems provides enterprise leadership for regulatory intelligence, quality management document governance, and electronic Quality Management System processes. The role sets strategic direction, establishes governance and risk-based oversight, and drives organisation-wide implementation of evolving regulatory requirements across the GxP landscape. As a senior advisor to Quality Assurance leadership and cross-functional stakeholders, the role translates regulatory change into business priorities, sponsors complex transformation programmes, escalates material risks to senior forums, and ensures the organisation maintains compliant, inspection-ready, and sustainable quality systems.

RESPONSIBILITIES

• RIC Governance Leadership and Oversight: Provides strategic leadership and co-chairs the Regulatory Intelligence Committee (RIC), setting committee priorities, governance standards, decision pathways, meeting cadence, and performance expectations. Advises the Senior Quality Review forum and Senior Leadership Team on regulatory developments, enterprise risks, implementation readiness, and recommended strategic responses. Directs horizon scanning of the global regulatory landscape, integrating internal and external intelligence to anticipate emerging requirements, risks, and business opportunities.
• Regulatory Intelligence Programme Delivery: Directs enterprise assessment and response planning for emerging global and local regulatory requirements, including ICH E6(R3) Principles and Annexes 1 and 2, the Declaration of Helsinki, MHRA Clinical Trial Regulations, FDA artificial intelligence guidance, EMA computerised systems requirements, medical device and IVDR requirements, and other relevant guidance.
• Regulatory Impact Assessment, Governance and Implementation: Provides senior sponsorship and governance for the organisation’s regulatory implementation portfolio, establishing clear decision rights, governance structures, milestones, and success measures.
• Process and Governance Improvements: Owns the strategic development and ongoing evolution of the RIC Portal as the authoritative enterprise source for impact assessments, governance records, meeting materials, dashboards, decisions, and regulatory intelligence.
• Non-GCP Compliance Readiness Initiatives: Sponsors RIC-led programmes addressing regulatory coverage gaps beyond core GCP requirements, including medical device and other requirements relevant to Worldwide’s business model.
• QMD and eQMS Management: Acts as the senior champion for Worldwide’s Regulatory Intelligence, QMS, and eQMS strategy, influencing adoption, investment priorities, and continuous improvement.
• People Leadership and General Responsibilities: Leads the QMD Deviation and QMS Continuous Improvement team, setting direction, allocating resources, building capability, and creating a culture of accountability, collaboration, and high performance.

OTHER SKILLS AND ABILITIES

Demonstrates senior-level communication and the ability to translate complex regulatory and quality matters into clear business implications, options, and recommendations. Applies enterprise-wide strategic thinking, sound judgement, and a risk-based approach to ambiguous, complex, and high-impact issues. Influences senior leaders and cross-functional stakeholders without direct authority, building alignment around quality, compliance, and transformation priorities.

REQUIREMENTS

• Advanced written and verbal English communication skills, including the ability to engage effectively with senior and external stakeholders.
• Substantial leadership experience in GxP quality systems, regulatory intelligence, controlled-document governance, or related quality disciplines within a complex global organisation.
• Demonstrated experience supporting and providing leadership during regulatory inspections, audits, and significant compliance-readiness activities.
• Deep working knowledge of ICH guidelines, FDA regulations, European requirements, MHRA statutory instruments, and the evolving global GxP regulatory landscape.
• Strong understanding of the drug-development lifecycle and the business impact of regulatory and quality-system change.
• Master’s degree in a scientific or allied health field with at least eight years of relevant GxP experience, or a bachelor’s degree in a biological, physical, health, pharmacy, or related field with at least ten years of progressive GCP, GLP, GVP, quality-system, or regulatory experience.

ABOUT US

Discover the Difference We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.