Responsible for the analysis of company quality requirements and the establishment,implementation and control of quality assurance systems and procedures across multipledisciplines. Has extensive experience across a range of business areas. Will lead a team ofqualityprofessionals. Reports to the Senior Director, Quality Management.

The Oncology Clinical Quality Director (O-CQD) willbe responsible forthe managementand oversight of theLDO Quality AssociateDirectors.

Typical Accountabilities

• Build strong relationships and strategic partnerships; collaborate proactivelyacross functionsand HUBsto driveadherence to compliance requirementswhileoperatingeffectively in ambiguity.

• Lead, develop, and coach a geographically and culturally diverse team of quality professionals.

• Embed quality frameworks, risk management approaches, and compliance strategy with senior leadership andemployees.

• Interpret complex data to assess quality performance and recommend compliance improvements and risk mitigations across LDO Clinical Operations.

• Provide expert quality advice and coaching to direct reports andLDOClinOpsteams on complexcompliancematters, including risk identification and compliance improvement strategies, initiatives, and plans.

• SupportLDOClinOpsteams in driving a quality mindset and culture, including resolution of sophisticated quality matters (e.g., serious breaches, fraud,poor quality).

• Lead Quality Management Reviews byconsolidatingand strategically communicating key compliance-relevant insights on country/regionaland functionalperformance to enable continuous improvement.

• Seek, engage, and leadcompliancecollaborationsacross LDOClinOps, and otherR&D Functionsto deliver effective, sustainable issue resolution.

• IdentifyandconsolidateLDOclinops/country/regionaland HUBrisks; escalate asrequired; define, support, and lead(asappropriate)risk mitigation(compliance)activities end-to-end.

• AdviseonAZ procedural framework (global clinical processes, procedural documents, Quality & Compliance manual) and applicable guidelines/standards and local regulations (including ICH-GCP).

• Providesenior-level advice on localand/or internationalclinical trial regulations; remain current on changes and ensure teams/processes are updated accordingly.

• Share learnings from auditsandinspections withLDOclinopsemployees; cascadeglobal/regional learnings across local, regional, and global stakeholders.

• Act as the interface withglobalstakeholders (e.g., legal advice,ethics,nominated signatory,GxPfunction) for quality-related topics.

• Represent the function in external expert groups (regulatory or operational) asrequired.

Minimum Requirements

• Bachelorsor advanceddegreerequiredin a science related field.

• Approximately 10 yearsdemonstratingexcellent knowledge of international regulations and guidelines; deep experience engaging global regulators (FDA, PMDA, EMEA, Health Canada), including inspection conduct in the clinical research industry.

• Significant clinical research quality and compliance experience; deep knowledge of ICH-GCP and applicability to clinical operations at both sponsor and site levels.

• Strong understanding of the drug development process and relatedGxPactivities, including successful clinical study delivery (e.g., ICH-GCP, study management).

• Broad experience in the pharmaceutical industry within aGxP-regulated environment.

• Proven leadershipand line management skills thathelpsteams excel in a regulated environment.

• Excellent communication skills with a proventrack recordof effective cross-functional and global networking.

• Strong critical thinking and risk-based decision-making skills.

• Effective analytical, problem-solving, negotiation, and conflict resolution skills.

• Demonstrated ability to set and manage priorities, performance targets, and project initiatives in a global environment.

• Ability to collaborate proactively,operateeffectively in ambiguity, and build strong customer relationships/strategic partnerships to enable process and system harmonization/standardization.