Associate Director, Compliance Biosamples
Location: Cambridgeshire, Gaithersburg, Maryland
Job Type: Full time
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 welcomed 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 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
Ensuring 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
Education, Qualifications, Skills and Experience:
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
Willingness to take decisions.
Fluent in English as the AstraZeneca working language
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
- UK, Cambridge (Melbourn Science Park)
- USA, Gaithersburg
- Sweden, Gothenburg
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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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.