Director Quality Management Late Development Oncology Clinical Operations (Americas

Typical Accountabilities

• Build strong relationships and strategic partnerships; collaborate proactively across functions and HUBsto drive adherence 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 and employees.

• 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 by consolidating and strategically communicating key compliance-relevant insights on country/regional and functional performance to enable continuous improvement.

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

• IdentifyandconsolidateLDOclinops/country/regional and H UBrisks; escalates as required; define, support, and lead(as appropriate) 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).

• Provide senior-level advice on localand/or international clinical trial regulations; remain current on changes and ensure teams/processes are updated accordingly.

• Share learnings from auditsandinspections withLDOclinopsemployees; cascade global/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) as required.

• Bachelor’sor 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 related
  
  GxPactivities, including successful clinical study delivery (e.g., ICH-GCP, study management).

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

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

• Excellent communication skills with a proven track 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,operate effectively in ambiguity, and build strong customer relationships/strategic partnerships to enable process and system harmonization/standardization.

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