Associate Director, Compliance Biosamples

Would you like to use your experience in Biosamples Regulations to make a positive impact to millions of patients' lives across the world? If you would, this could be the role for you... At AstraZeneca be empowered to be innovative and creative where difference is valued. Join a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve 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. The HBS Compliance Associate Director is responsible for defining and managing processes to deliver HBS compliance across AstraZeneca R&D. They identify and support establishment of effective HBS compliance procedures and advise the business on requirements. This includes requirements related to 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 encouraged to ensure senior leaders are aware of changing regulations and the impact to AZ of these changes. Typical Accountabilities, what you will be doing: Lead the Identification and establishment of effective HBS compliance procedures across R&D. Lead HBS processes to ensure standards are adhered to and compliance requirements are consistently applied Ensuring senior collaborators 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 Supervise the efficiency of HBS due diligence processes and find 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 partners Minimum Requirements: Bachelor’s degree in a scientific or related field Minimum of 5 years of experience 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 Willingness to take decisions. Proficient in English as the AstraZeneca working language Desirable: Direct experience of working with HBS Experienced of working with multiple collaborators 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 Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods, and bringing unexpected teams together. Interested? Come and join our journey. So, what’s next! Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=e Date Posted 20-Oct-2023 Closing Date 25-Feb-2024 When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.