Director, Clinical Quality Assurance

This position supports Agenus Clinical Quality Assurance (CQA) by providing independent Good Clinical Practice (GCP) oversight , guidance, and support to cross-functional clinical teams to help ensure compliance with regulatory requirements, GCP guidelines and Agenus Standard Operating Procedures (SOP) for the conduct of clinical trials.
Full Time Remote in United States Quality
Annually: USD 0 - 0
(UTC-05:00) Eastern Time (US and Canada)
Clinical Quality Director
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We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

This position supports Agenus Clinical Quality Assurance (CQA) by providing independent Good Clinical Practice (GCP) oversight , guidance, and support to cross-functional clinical teams to help ensure compliance with regulatory requirements, GCP guidelines and Agenus Standard Operating Procedures (SOP) for the conduct of clinical trials.

This position will report to the Sr. Director, Clinical Compliance and Inspection Management.

Key responsibilities in this role include, but are not limited to:

  • Participates and collaborates as a team member on assigned clinical trials providing clinical quality assurance oversight , GCP consultation , and ongoing risk assessment of clinical trial activities .
  • Supports the development, implementation, and continuous improvement of processes and tools with functional area leadership, applicable partners, and Clinical Research Organizations (CRO) ensuring GCP compliance and consistent protocol execution.
  • Supports internal teams and investigator sites requiring risk mitigations (including site quality management and training) and identifies potential investigator site audit s through risk-based criteria for the Agenus audit program.
  • Identifies and escalates significant compliance issues to Clinical Quality Assurance leadership and relevant functional area leadership.
  • Supports and/or leads cross-functional teams with quality issue/event escalation, criticality assessment, investigation, root cause analysis, corrective/preventive actions and trending analysis .
  • Provides support and guidance before, during and following internal audits, partner audits and regulatory inspections.
  • Maintains a high level of expertise in GCP drug development regulations, ICH guidelines and internal policies and procedures that may impact drug development.
  • Supports and/or leads key strategic organizational quality and compliance process improvement initiatives.

Education

  • Bachelor of Science, health sciences or quality-related field
  • Professional Skills, Qualifications and Experience
  • A minimum of 10 years in a pharmaceutical drug development, biotech (or equivalent) in a GCP and/or Safety/Pharmacovigilance discipline with a minimum of five years of experience in Clinical Quality Assurance.
  • Expert knowledge and interpretation of GCP regulations and standards, with understanding of phase appropriate application of GCP expectations.
  • Direct experience with FDA, EMA, MHRA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
  • Excellent teamwork skills with the ability to develop and maintain positive, collaborative relationships with colleagues at all levels across the organization.
  • Strong verbal and written communication with the ability to effectively communicate to multiple levels in the organization.
  • Ability to influence people at different levels and negotiate cross-functionally in a matrix organization.
  • Strong analytical skills, problem solving techniques, and understanding of ensuring level of effort to address observations/quality issues is commensurate with risk .
  • Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
  • Travel Requirements
  • Willing to travel domestically and internationally approximately 20% of the time, per business needs.
  • Physical Requirements
  • Required to operate computers and other standard office equipment which may require sitting for extended periods of time.  

Posted 6 months ago

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