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, entrepreneurial 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.
Locations: Krakow, PL, Mississauga, CA, or Barcelona, ES
Reporting to the Senior Director, Clinical Quality and Compliance (CQC), this roles offers an exciting opportunity to develop and grow within a collaborative, centralized team of Clinical functional Partners, responsible for providing quality/ compliance related support and expertise to Development Operations and other Clinical Trial functions within R&D. Ensuring quality is built in and monitored for compliance issues, risks and improvements, embedding quality through standardized quality metrics / compliance measures and proactively driving inspection readiness within the organization.
As Associate Director, CQC , you will actively support the CFP team in the development and implementation of the core activities of CQC. Responsibilities will include establishing and maintaining effective systems and processes to support and maintain Quality Management excellence, to collaborate effectively with colleagues and partners in support of quality and compliance related initiatives/activities and to act as a quality champion; advocating a culture of quality across R&D.
The role will serve as functional partner to various clinical trial functions within R&D, and will offer a unique opportunity to grow in the area of quality and compliance.
You will contribute to the management of quality events, initiatives and improvement programs (quality issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes), helping to ensure quality performance metrics in all of the above activities remain on track, and providing compliance advice and guidance on GCP or other relevant regulatory standards - in line with your area of expertise.
If you are proactive, performance driven, solutions focused and with a quality mindset, and looking to become part of a high performing team passionate about maintaining compliance whilst improving our ways of working, this could be the perfect role for you to develop your career.
Essential requirements:
University degree in related subject area, preferably in life science or equivalent. Higher degree in a scientific or business field is desirable.
Demonstrable experience in a clinical compliance or quality related position or a role within study management.
Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.
Highly developed problem solving skills and the ability to resolve difficult conflicts.
Strong interpersonal and communication skills with the ability to influence others.
Ability to multitask and to work efficiently and independently under pressure.
Demonstrated project management skills.
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