Associate Director, Quality Management Systems

Worldwide Clinical Trials

. Provides enterprise leadership for regulatory intelligence, quality management document governance, and electronic Quality Management System processes .

Posted 10/27/2026full-timeSydney • AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP quality systems, regulatory intelligence, and quality management processes, with a strong focus on compliance, governance, and strategic leadership. Proven ability to influence stakeholders and lead cross-functional initiatives while ensuring inspection readiness and adherence to regulatory standards.

Highest-signal resume keywords

GxP Quality Systems LeadershipRegulatory Intelligence ExpertiseQMS Compliance KnowledgeStakeholder EngagementChange Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceQuality Management SystemsControlled Document GovernanceICH GuidelinesFDA Regulations21 CFR Part 11Quality Tolerance LimitsKey Quality IndicatorsDrug-Development LifecycleRegulatory Inspection Leadership

Soft Skills

Advanced English CommunicationLeadership ExperienceCoaching and MentoringInfluencing SkillsPerformance Leadership

Tools & Technologies

Microsoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft SharePointTrackWise

Industry Keywords

GCPGLPGVPRegulatory LandscapeCompliance-ReadinessCross-Functional ProgrammesGovernance StandardsInspection ReadinessQMD GovernanceEMA Compliance

About the role

Key responsibilities & impact

Provides enterprise leadership for regulatory intelligence, quality management document governance, and electronic Quality Management System processes
Sets strategic direction and establishes governance and risk-based oversight across the GxP landscape
Co-chairs the Regulatory Intelligence Committee and sets priorities, governance standards, decision pathways, meeting cadence, and performance expectations
Advises senior quality and leadership forums on regulatory developments, enterprise risks, implementation readiness, and strategic responses
Directs horizon scanning and enterprise assessment of global and local regulatory requirements
Sponsors cross-functional regulatory intelligence and implementation programmes, resolves barriers, aligns senior stakeholders, and holds programme owners accountable
Directs review and revision of QMS processes and controlled documents affected by regulatory changes
Leads cross-functional change and stakeholder engagement across functions, systems, and study teams
Owns the RIC Portal and leads governance transformation initiatives
Establishes standards and performance measures for regulatory intelligence and implementation activities
Sponsors non-GCP compliance readiness initiatives and oversees EMA computerised systems compliance
Ensures inspection readiness through complete, reliable, and auditable evidence
Acts as senior champion for Regulatory Intelligence, QMS, and eQMS strategy
Owns the QMD lifecycle governance framework and co-chairs the QMD Governance Committee
Provides expertise on QMS compliance, QMD governance, and QMD deviation management
Defines and monitors Key Quality Indicators and Quality Tolerance Limits
Leads the QMD Deviation and QMS Continuous Improvement team
Translates enterprise Quality and QMS strategy into functional objectives, priorities, delivery plans, and measurable outcomes
Represents Quality Management Systems in senior and cross-functional governance forums
Builds succession and organisational capability through coaching, mentoring, and performance leadership
Leads complex cross-functional initiatives and performs other leadership responsibilities aligned with the role

Requirements

What you’ll need

Advanced written and verbal English communication skills
Substantial leadership experience in GxP quality systems, regulatory intelligence, controlled-document governance, or related quality disciplines within a complex global organisation
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
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; evaluation is based on proven competency, level of responsibility, and ability to work independently

Benefits

Comp & perks

Collaborative and inclusive work environment
Growth and career development opportunities
Coaching, mentoring, and targeted development opportunities
Opportunity to learn, grow, and help shape the future of clinical research