Director Quality Management Late Development Oncology Clinical Operations (Americas)

AstraZeneca•Wilmington, DE

About The Position

Responsible for the analysis of company quality requirements and the establishment, implementation and control of quality assurance systems and procedures across multiple disciplines. Has extensive experience across a range of business areas. Will lead a team of quality professionals. Reports to the Senior Director, Quality Management. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you are our kind of person. At the heart of AstraZeneca, our team is committed and encouraged to follow the science. Driven by our curiosity, passion, and determination, we are paving the way to change the practice of medicine in Oncology. The Oncology Clinical Quality Director (O-CQD) will be responsible for the management and oversight of the LDO Quality Associate Directors.

Requirements

Bachelor’s or advanced degree required in a science related field.
Approximately 10 years demonstrating excellent 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 GxP activities, including successful clinical study delivery (e.g., ICH-GCP, study management).
Broad experience in the pharmaceutical industry within a GxP-regulated environment.
Proven leadership and line management skills that helps teams excel in a regulated environment.
Excellent communication skills with a proven track record of 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.

Responsibilities

Build strong relationships and strategic partnerships; collaborate proactively across functions and HUBs to drive adherence to compliance requirements while operating effectively 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 and LDO ClinOps teams on complex compliance matters, including risk identification and compliance improvement strategies, initiatives, and plans.
Support LDO ClinOps teams 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 lead compliance collaborations across LDO ClinOps, and other R&D Functions to deliver effective, sustainable issue resolution.
Identify and consolidate LDO clinops/country/regional and HUB risks; escalate as required; define, support, and lead (as appropriate) risk mitigation (compliance) activities end-to-end.
Advise on AZ 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 local and/or international clinical trial regulations; remain current on changes and ensure teams/processes are updated accordingly.
Share learnings from audits and inspections with LDO clinops employees; cascade global /regional learnings across local, regional, and global stakeholders.
Act as the interface with global stakeholders (e.g., legal advice, ethics, nominated signatory, GxP function) for quality-related topics.
Represent the function in external expert groups (regulatory or operational) as required.