Global Quality & Compliance Director - Clinical Operations

AstraZeneca GmbH; Wilmington (DE); On-site; USD 130,000 - 170,000; Full time

Job summary

AstraZeneca GmbH in the United States is seeking a senior quality and compliance leader to build strong relationships, embed quality frameworks, and drive global regulatory adherence across clinical operations.

You will lead a geographically diverse team, provide expert advice on ICH-GCP and local regulations, and partner with cross-functional stakeholders to deliver sustainable issue resolution and continuous improvement.

Qualifications

• 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), 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 help 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; escalates 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.

Skills

Regulatory knowledge

Leadership

Communication

Risk assessment

Global stakeholder management

Decision making

Problem solving

Negotiation

Education

Bachelor’s or advanced degree in science

Job description

AstraZeneca GmbH in the United States is seeking a senior quality and compliance leader to build strong relationships, embed quality frameworks, and drive global regulatory adherence across clinical operations.

You will lead a geographically diverse team, provide expert advice on ICH-GCP and local regulations, and partner with cross-functional stakeholders to deliver sustainable issue resolution and continuous improvement.