The Senior Manager, Quality GCP & PV is responsible for performing domestic and international inspections that ensure compliance with the FDA and other worldwide health authority regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. The senior manager provides recommendations for corrective and preventive action and tracks corrective action commitments until closure.
Essential Duties and Responsibilities include the following:
Plans and conducts document, internal and external audits:
o GCP audits of clinical research activities to assess compliance with FDA and ICH GCP, and local regulations, as well as with protocol and company SOPs. Routine reviews of documentation include, but are not limited to protocols, case report forms, tables and listings, investigator brochures, informed consent forms and clinical study reports.
o GPvP audits to assess compliance with FDA and applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations, as applicable. Routine reviews of documentation include, but are not limited to PV-plans, individual case processing, aggregate reports (e.g. PADER), REMS related documents, safety database files and clinical trial adverse event reports.
Audits and evaluates service providers (e.g. clinical investigational sites, CROs, Drug Safety service providers, licensing partners, Specialty Pharmacy), as appropriate, to assess capabilities and compliance with applicable regulations as well as with company policies and procedures.
Works closely with the internal staff and Service Providers to identify, evaluate, and recommend solutions to issues identified in the performance of GCP and GPvP audits (i.e. work with Clinical Operations for GCP, and with Drug Safety and Risk Management staff for GPvP audits).
Prepares clear and concise written reports of audit observations, including an assessment of compliance.
Evaluates responses and corrective and preventive action plans to audit findings for adequacy and timeliness and manage the closeout of all corrective and preventive actions.
Maintains Quality documentation files, databases and logs. Tracks metrics and trends as well as compliance issues and their resolution.
Assists with GCP and GPvP training internally, and where required externally of investigators, service providers, licensing partners, etc.
Works with the Head of Quality to assure alignment and compliance with their Quality Management System, support assessment of compliance and define metrics to determine performance objectives.
Reviews internal and external SOPs. Participates in the development of departmental SOPs, as appropriate.
Participates in Process Improvement teams.
Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures related to GCP, GPvP and Quality to associates.
Provides support during compliance inspections conducted by external sources (i.e. health authorities)
Plans and conducts domestic inspections.
Participates in the planning and conducting process of international inspections.