Associate Director, Clinical Quality Performance

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and _BlueSky Hub_ in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our commitment to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Our Position**

Reporting to the Senior Director, Clinical Quality Performance (CQP), the Senior Quality Lead supports the delivery of Quality Management activities related to clinical development within R&D, working across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Development Operations and other Clinical R&D functions.

**Accountabilities/Responsibilities**:

- Establish and maintain effective systems and processes to support key performance areas for Clinical Quality Compliance (CQC) to maintain Quality Management excellence
- Collaborate effectively with colleagues to support initiatives/activities and act as a quality champion advocating a culture of quality across R&D.
- Provide advice and standard process guidance on GCP or other relevant regulatory standards (such as GCP for labs, GAMP, 21 CFR Part 11, etc.) for quality events, initiatives and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes).
- Where necessary, empower clinical colleagues to conduct root cause analysis and defined CAPA plans and effectiveness check plans). Assist functional partners with CAPA effectiveness checks.
- Assist functional representatives as they prepare for regulatory inspections (where necessary)
- Coordination of defined GCP systems audits and advising where necessary on other audit outcomes (responses, CAPAs, lessons learned)
- Support identification and management of quality risks, including mitigation of risks and communication of significant risks to management
- Assist with CQC communications and issue resolution
- Assist with identifying and implementing continuous improvements by reporting new insights of quality related trends and metrics, highlighting areas of need where necessary, and tracking related activities.
- Actively participate in internal and external quality groups/operational committees, sharing relevant information, experience/knowledge, focused on improving the way of working.
- Support CQC Leadership in the strategic direction and priorities of the group. Contribute to CQC objectives and strategies that drive a culture of quality.
- Maintain current knowledge and awareness of regulations / guidance as well as any internal processes pertaining to clinical trials; provide interpretations of regulations and assessing impact on our systems and providing recommendations
- Review and scrutinize learning curriculum assignments and obtain senior CQC approval of final assignment to ensure appropriate and reasonable curricula are in place
- Assist in creation and maintenance of tools and processes to proactively address readiness for internal and regulatory GCP/GXP audits, inspections, and overall clinical quality work
- Conduct Quality Reviews for key validation documentation based on a risk-based approach

**Education and Experience**
- University degree, preferably in life science or equivalent. Higher degree in scientific or business specialization is desirable
- Solid understanding and experience in a clinical compliance or quality related position with a track record of success in managing quality and compliance activities
- Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.
- Highly developed problem solving skills and the ability to resolve issues
- Strong interpersonal and communication skills able to influence others through leadership skills
- Ability to multitask and to work efficiently and independently under pressure.

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