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. 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 information, and senior decision-making.

- Establishes enterprise standards for tracking, assessing, approving, and communicating regulatory intelligence and associated implementation activity.

- Defines governance performance measures, interprets trends, and provides senior leadership with assurance on committee effectiveness, assessment quality, action completion, and organisational readiness.

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.

- Establishes governance, senior sponsorship, subject-matter expert engagement, and risk-based gap assessments for non-GCP requirements, including medical device and IVDR obligations.

- Provides senior governance oversight of the EMA computerised systems compliance programme, challenging delivery, risk positioning, action closure, and vendor-related initiatives.

- Ensures inspection readiness by requiring complete, reliable, and auditable evidence of regulatory assessments, decisions, risk acceptances, actions, communications, and implementation status.

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.

- Owns the governance framework for the QMD lifecycle and ensures controlled-document processes remain compliant, efficient, scalable, and aligned with record-retention requirements.

- Co-chairs the QMD Governance Committee, setting its strategic agenda and ensuring effective execution of its Charter, decisions, and accountabilities.

- Serves as the senior Process Management subject-matter expert and trusted advisor to functional leaders on QMS compliance, QMD governance, and QMD deviation management.

- Provides oversight of external QMD dissemination and the QMD deviation process, using trend analysis to identify systemic risk and drive preventive improvement.

- Defines and monitors Key Quality Indicators and Quality Tolerance Limits for Regulatory Intelligence and QMD deviations, escalating adverse trends and ensuring corrective action.

- Provides strategic QMS and process-governance expertise to Worldwide’s Audit and Inspection Programme and supports senior leadership during regulatory inspections.

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.

- Translates enterprise Quality and QMS strategy into clear functional objectives, priorities, delivery plans, and measurable outcomes.

- Represents RIC Quality Management Systems in senior, departmental, and cross-functional governance forums and influences decisions affecting quality, compliance, and business operations.

- Builds succession and organisational capability through coaching, mentoring, performance leadership, and targeted development of team members and subject-matter experts.

- Leads complex cross-functional initiatives requiring significant organisational alignment, change leadership, and senior stakeholder engagement.

- Performs other leadership responsibilities aligned with the scope and level of the role.

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.

- Leads organisational change, resolves competing priorities, and negotiates effective outcomes across functions and geographies.

- Uses data, management information, and trend analysis to challenge performance, support investment decisions, and drive sustainable improvement.

- Directs complex programmes and governance activities involving multiple stakeholders, dependencies, and regulatory commitments.

- Anticipates risk, makes timely decisions, and escalates material concerns with clear recommendations and proposed mitigations.

- Builds high-performing teams and organisational capability through visible leadership, coaching, delegation, and accountability.

- Operates with a high degree of autonomy, integrity, discretion, and ownership.

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.

- Strong knowledge of 21 CFR Part 11 and international requirements governing electronic records, electronic signatures, and validated quality systems.

- Proven ability to lead enterprise governance forums, sponsor cross-functional programmes, influence senior stakeholders, and translate regulatory requirements into sustainable operating models.

- Proficiency with Microsoft Excel, Word, PowerPoint, and SharePoint; experience with TrackWise or comparable eQMS platforms is desirable.

- 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.

- Experience leading teams, developing talent, managing complex portfolios, and operating across global and matrixed environments.

- Ability to undertake domestic and international travel of approximately 10%.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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 .