Associate Director, Compliance Human Biological Samples

Responsibilities:

• Excellent employment opportunity for an Associate Director, Compliance Human Biological Samples in the Gaithersburg, MD area.
• 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
  

Experience:

• B.S. Degreed 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
• 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