Associate Director Quality Management (Late Development Oncology - Clinical Operations)

AstraZeneca • Mississauga, ON

57d

About The Position

The Associate Director, Quality Management (ADQM) identifies, develops, tracks, and analyzes quality metrics and their impact on Late Development Oncology Clinical Operations. The ADQM provides guidance on using business processes and existing systems to help Clinical Operations teams deliver drug and non-drug projects to agreed quality standards, maintaining an ‘always inspection-ready’ state.
The ADQM leverages global SOPs, processes, procedures, technology, and training frameworks to provide compliance guidance to Late Development Oncology Clinical Operations staff, and to identify and communicate improvement opportunities to process and system owners.

Requirements

• Undergraduate degree in life sciences or an equivalent related field.
• In-depth knowledge and broad experience in the pharmaceutical/biopharma industry within a GxP-regulated environment.
• Excellent communication, influencing, and networking skills, with a proven ability to work effectively cross-functionally and globally.
• Strong critical thinking and sound judgment, with the ability to communicate clearly on complex compliance topics.
• Demonstrated stakeholder management skills and the ability to operate effectively at all organizational levels.
• Strong risk-based decision-making skills.
• Excellent understanding of the drug development process and related GxP activities.
• Strong understanding of the skills and knowledge required for successful clinical study delivery (e.g., ICH-GCP, study management).
• Excellent knowledge of international regulations and guidelines, as well as the AZ Procedural Framework.
• Ability to collaborate proactively, navigate ambiguity, and build strong working relationships across multiple domains to enable process and system harmonization and standardization.

Nice To Haves

• Advanced degree in life sciences or an equivalent related field
• Experience working with global and remote cross functional teams
• Ability to work in an environment of remote collaborators
• Experienced reputation within the business and industry
• Good cultural awareness

Responsibilities

• Review, assess, and communicate the status of the Quality Management System (QMS) framework for Late Development Oncology Clinical Operations, partnering with stakeholders and business process owners to recommend continuous improvements.
• Support execution of the Late Development Oncology Clinical Operations Quality Framework as first-line quality support to enable high-quality delivery of clinical trials.
• Drive strategic quality focus across the Late Development Oncology portfolio in partnership with supporting functions.
• Support adherence to ICH-GCP and Late Development Oncology Clinical Operations objectives.
• Provide first-line quality and compliance advice to Late Development Oncology Clinical Operations to facilitate timely resolution of compliance issues and sharing of good practices and learnings.
• Champion an engaging quality culture within Late Development Oncology Clinical Operations, promoting an ‘always inspection-ready’ mindset; define compliance improvement recommendations and initiatives; and provide study/program/site-level support during RIST (Regulatory Inspection Support Team) activities.
• Translate quality metrics into actionable insights for Late Development Oncology Clinical Operations to support performance improvement.
• Lead and support quality review meetings with Late Development Oncology Clinical Operations leadership.
• Collaborate with quality functions and partners through the Late Development Oncology Clinical Operations Quality Network to drive sustainable issue resolution.
• Proactively seek improvement opportunities and feedback from Late Development Oncology Clinical Operations teams, supporting knowledge sharing and learning (e.g., audit and inspection learnings).
• Identify, calibrate, and track risks; escalate as needed; and define or support risk mitigation activities.

Benefits

• annual Variable Pay Bonus/Short Term Incentive opportunity
• eligibility to participate in our equity-based long-term incentive program (if applicable to role)
• competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• annual Personal Days

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees