HBS Compliance Excellence Lead

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 the collection, handling, and access to HBS are subject to strict regulations, principles, and ethical guidelines.

As the HBS Compliance Excellence Lead, you will be responsible for designing, implementing, and managing processes to ensure HBS compliance across AstraZeneca R&D. You will identify and lead the establishment of effective HBS compliance procedures. This role requires extensive specialist knowledge to advise on compliance requirements in a time-constrained environment. You will handle requirements related to the re-use of AZ samples, external sourcing of HBS, and related services and collaborations. Additionally, you will provide and implement procedures that might not be popular but are essential to protect AZ's license to operate.

You will also be accountable for the requirements of the HBS BPAL role and responsible for the training program to enable HBS Compliance across R&D. This includes developing and ensuring the delivery of HBS training and maintaining associated standards and processes. The BPAL role is a senior position with expertise across a wide process area, working strategically with the AZ R&D Process Governance Board to ensure streamlined compliance and successful Procedural Framework integration. This role also supports activities related to HBS for Divestments, Acquisitions, and Collaborations (DAC), including pre-deal due diligence and post-deal integration activities.

Accountabilities:

• Identify, develop, and lead the establishment of an effective and strategic HBS compliance program across R&D.

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

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

• Supervise the maintenance and documentation/SOPs associated with HBS due diligence activities (including conduct of monitoring activities, support for auditing, investigations, assurance reporting, etc.).

• Set operational compliance objectives (aligned with Global Compliance strategy and objectives) to ensure an embedded and streamlined approach to governance and assurance.

• Manage local/area oversight of all aspects of governance, including working with counterparts in other SET areas in areas of overlapping accountability.

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

• Support approval of HBS suppliers and orders and support activities to enable access to new HBS sources.

• Drive alignment of the strategies, governance, and processes for use of HBS across R&D.

• Ensure learning from HBS-related issues are identified and analyzed to enable continuous process improvement.

• Provide expert guidance and advice to ensure HBS usage, storage, and acquisition activities are compliant with global regulations.

• Act as a subject matter expert for HBS processes, making recommendations and carrying out audits to ensure compliant process and learning management are implemented to allow compliant use of HBS.

• Active member of HBS Governance and Compliance and other Process and Learning related forums, supporting activities related to HBS for Divestments, Acquisitions, and Collaborations (DAC), including pre-deal due diligence and post-deal integration activities including the dissemination of policy positions and decisions to key stakeholders.

• Support implementation of AZ risk framework and risk register.

• Oversight and monitoring of HBS incidents and process strategy for oversight in collaboration QA use of VQV area.

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

• Auditing of HBS activities in line with HTA and HBS requirements in collaboration with QA.

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 even when difficult or a senior leader

• Strong collaborative, partnering, and interpersonal skills

• Strong ability to work independently

• Willingness to take decisions

• Fluent in English as the AstraZeneca working language

• Specialist HBS regulatory knowledge

Desirable for the Role:

• Direct experience of working with HBS

• Knowledge of HBS regulations, laws, and standards

• Experience working with multiple stakeholders

• Previous experience as a process owner and process improvement

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.

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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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