Director Quality Management Late Development Oncology Clinical Operations (Americas)

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 fraudpoor 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 as; 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 adviceethicsnominated signatoryGxPfunction) for quality-related topics.

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

Minimum Requirements

• Bachelorsor advanceddegreein 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 proactivelyoperateeffectively in ambiguity and build strong customer relationships/strategic partnerships to enable process and system harmonization/standardization.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you!