Associate Director, Compliance Human Biological Samples

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.
AstraZeneca is searching for a candidate that has several years of experience working with HBS and is ready for a new role!

Responsibilities
• 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

Your profile
Required Skills
• 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
• 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

About the organisation
This position is a consultant assignment for one year at AstraZeneca in Göteborg. During this time you will be employed by QRIOS Life Science & Engineering.

QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER.