HBS Compliance Associate Director

WHY JOIN US?

At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.

Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives.

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 is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

About the Opportunity:

Human Biological Samples (HBS) are fundamental to medical research in the discovery, development, and implementation of new treatments and diagnostics. HBS are ethically sensitive materials, and their collection, handling, and access are subject to strict regulations, principles, and ethical guidelines.

The HBS Compliance Associate Director is responsible for defining and managing processes to deliver HBS compliance across AstraZeneca R&D. They identify and support the establishment of effective HBS compliance procedures and advise the business on requirements. This includes requirements related to the re-use of AZ samples, external sourcing of HBS, and related services and collaborations. The role may support clinical or pre-clinical activities as required by the business and is expected to ensure senior leaders are aware of changing regulations and the impact of these changes.

Accountabilities:

• Lead the identification and establishment of effective HBS compliance procedures across R&D.

• Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied.

• Ensure senior stakeholders are aware of changing legislation that impacts them.

• Support the business with compliant use of HBS through expert advice and decision-making.

• Ensure risks arising from HBS due diligence activities are identified and recorded.

• Maintain the documentation/SOPs associated with HBS due diligence activities.

• Monitor the effectiveness of HBS due diligence processes and identify opportunities for improvement.

• Support approval of HBS suppliers and orders to deliver timely and effective decisions.

• Perform HBS due diligence reviews for AZ clinical sample use and re-use requests for HBS in the biobank to support delivery of timely and effective decisions.

• Support activities to enable access to new HBS sources ensuring AZ compliance with regulation.

• Act as subject matter expert, reviewing informed consents and making recommendations on HBS use and carrying out audits to ensure compliant use of clinical HBS.

• Active member of HBS Governance and Compliance related forums, including the dissemination of policy positions and decisions to key stakeholders.

Essential for the Role:

• Degree level education

• Experience in pharmaceuticals, a healthcare-related industry, or academia/hospital environment related to HBS

• Excellent analytical, written, and oral communications skills

• High ethical standards, willingness to challenge inappropriate proposals/actions of senior leaders

• Strong collaborative, partnering, and interpersonal skills

• Strong ability to work independently

• Fluent in English as the AstraZeneca working language

• Knowledge of HBS regulations, laws, and standards

Desirable for the Role:

• Direct experience of working with HBS

• Experience working with multiple stakeholders

• Previous experience as a process owner and process improvement

• Experience in collection and use of HBS as part of ongoing clinical trials

• Expert in relevant global regulations relating to HBS

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
 

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel
   

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.