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 setting where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

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. Maintains oversight of the regulatory intelligence portfolio, ensuring timely impact assessment, clear accountability, effective risk mitigation, and escalation of high-impact topics into formally governed programmes. Owns the RIC operating model, including the Charter, position‑statement framework, governance documentation, decision records, and Worldwide‑SOP‑QA-048. Ensures RIC governance remains aligned with enterprise quality governance, portfolio priorities, and broader committee cycles.

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. Sets the risk‑based approach for regulatory impact assessments and ensures material topics are translated into approved strategies, resourced programmes, accountable action plans, and measurable implementation outcomes.



Sponsors cross‑functional regulatory intelligence programmes, resolves barriers, aligns senior stakeholders, and holds programme owners accountable for delivery. Shapes the organisation’s regulatory intelligence communication strategy through senior‑level updates, governance forums, newsletters, training, and digital knowledge resources. Ensures regulatory awareness and capability‑building programmes support timely adoption, sustained compliance, and organisational readiness.

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. Directs enterprise review and revision of QMS processes and controlled documents affected by new or revised regulatory requirements, ensuring changes are prioritised, resourced, implemented, and sustained. Oversees development of implementation strategies and enabling resources, including leadership briefings, study‑team information sessions, training materials, FAQs, communications, knowledge‑base content, and guidance repositories. Leads cross‑functional change and stakeholder engagement to embed revised regulatory frameworks across relevant functions, systems, and study teams.

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. Leads governance transformation initiatives that improve transparency, traceability, accountability, management

📌 Associate Director, Quality Management Systems (Australia)
🏢 Worldwide Clinical Trials Holdings
📍 Australia