Associate Director/Director, GCP QA 10/8/2017
Intarcia Therapeutics, Inc.
JOB DESCRIPTIONAPPLY As a key member of the Quality Assurance department, the Associate Director/Director, GCP QA is responsible for developing and implementing GCP procedures for managing Intarcia s clinical studies program. This individual will be the subject matter expert in GCP, develop standards and partner with Clinical Research, Contract Research Organization (CRO) and other clinical vendors to establish risk-based GCP quality systems processes and procedures. This position will serve as the key point of contact representing Intarcia GCP QA in various projects, liaising with CROs, Partners and various regulatory agencies on GCP related matters.
Duties and Responsibilities:
Develop quality systems SOPs for GCP to manage clinical studies program for US and ROW, including oversight of GCP activities managed by Intarcia CRO s and contracted vendors.
Ensure clinical trials are conducted in accordance with applicable study protocols, and in compliance with GCP and ICH guidelines.
Partner with Supply Chain, Clinical Research, Product Development, and CRO subject matter experts to identify and implement GCP procedures in compliance with GCP regulations/guidelines.
Establish quality agreements with clinical CRO and other vendors managing Intarcia s clinical study activities.
Manage clinical product complaints, quality incidents and CAPA associated with GCP and clinical trial material (CTM).
Partner with the Supply Chain to manage processes at the clinical packaging vendors, responsibilities include review and approval of master packaging records, executed batch records, specifications, investigations, CAPA, issuance of CoA for final release of the CTM and drug shipment.
Manage GLP/GCP Audit Program for the Clinical Studies
Develop audit plans and conduct GLP and GCP compliance audits, for e.g., Investigator sites, CRO facilities, Depots and other clinical vendors for study-specific compliance (as required).
Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management.
Conduct and coordinate GCP compliance training to internal and external customers (as required).
Lead inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP related matters.
Manage other QA responsibilities in GLP and GMP functions, as assigned by the Supervisor.