Director, GCP Quality Risk Management & Process Improvement

Agenus Lexington , MA 02421

Posted 4 weeks ago

Agenus is clinical stage, Immuno-Oncology (I/O) development company seeking a Sr. Director/Director of GCP Quality Risk Management (QRM) and Process Improvement (PI). The ideal candidate will have a broad management experience (10+ years) in Clinical Quality Assurance (CQA) supporting regulated drug/biologic research & development with a proven track record developing, implementing, assessing and improving clinical quality systems. This role will report to the VP, Quality Systems and have responsiblity for regulated Process Improvement initiatives, development and oversight of the Clinical Quality Issue Management process, further establishing and enhancing clinical quality systems and analytics, and lead GCP Inspection Readiness.

Roles And Responsibilities

  • As a member of Senior Quality leadership at Agenus, define strategic Quality objectives and provide leadership to the Global Agenus Quality Unit

  • Further develop and oversee GCP Quality Risk Management (QRM), emphasizing clinical quality issue management and quality data analytics (e.g., internal/external audit observations) enabling continuous process improvement of the Agenus Quality Management System (QMS).

  • Work closely with department heads and clinical trial functional leads to identify and mitigate quality system risks at the Organizational (i.e., QMS) and study/program-level (i.e., application of QRM to protocol) to ensure and facilitate consistent application of quality risk management.

  • Support and oversee continued development and enhancement to the Agenus clinical quality system (i.e., Policy, SOP, guidance) to enable consistent implementation of operational processes, systems and standards across trials

  • Administer Clinical Audit program

  • Lead GCP inspection readiness activities and coordinate overall inspection readiness with Agenus quality leadership and subject matter experts in regulated functional areas.

  • Participate in the development and execution of GCP, SOP, or Policy related training in collaboration with Agenus Training & Development.

Education and Background:

  • BS degree, scientific degree preferred

  • A minimum of 10 years experience working in drug/biologics development clinical QA or other GCP related discipline to include Quality Issue Management (CAPA), Quality Risk Management (QRM), Quality data analytics and/or regulated process improvement

  • Knowledge of global GCP regulations and guidance, and overall QMS requirements to enable quality, risk and compliance oversight

  • Knowledge and understanding of audit concepts enabling risk-based clinical auditing program

  • Six Sigma Black Belt, PMP certified, RQAP-GCP, ASQ certification desirable

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Director, GCP Quality Risk Management & Process Improvement