Associate Director, Compliance Human Biological Samples

Human Biological Samples (HBS)

Hays Life Sciences is now looking to recruit an Associate Director, Compliance Human Biological Samples for a 1-year contract assignment at AstraZeneca in Gothenburg.

Reason for the role:
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.

Day-to-Day Duties

* 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

Required Skills/ Experience/ Education/ Qualifications

* 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

Desirable Skills/ Experience/ Education/ Qualifications

* 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