Associate Director, Compliance Biosamples - Cell Therapy

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...

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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 in relation to programmes involving use of HBS in Cell Therapies. They identify and support establishment of effective HBS compliance procedures and advise the business on requirements. This includes requirements related to use of HBS in developing Cell Therapy strategies with respect to AZ HBS policies and standards, working with Biosamples Clinical Sampling on studies using such therapies.

The role may support clinical or pre-clinical activities as required by the buisness and is expected 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.

• Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied for use of HBS in development of Cell Therapies.

• Ensuring senior stakeholders are aware of changing legisation that impacts them

• Support the buisness 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 clincial 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 related to Cell therapy strategies.

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

Education, Qualifications, Skills and Experience:

Essential:

• Degree level education

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

• Excellent analytical, written and oral communications skills

• Knowledge of strategies for development of Cell Therapies and relevant regulations

• 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.

• Fluent in English as the AstraZeneca working language

• Knowledge of HBS regulations, laws and standards

Desirable:

• Direct experience of working with HBS

• Experienced of 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 and cell therapies

Locations:

- UK, Cambridge (Melbourn Science Park)

- USA, Gaithersburg

- Sweden, Gothenburg

- Canada, Toronto

Salary: Competitive + Excellent Benefits

Next steps, if the role looks suitable please apply with your cover letter.

Where can I find out more?

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Date Posted

Closing Date

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.