Come join a dynamic late-stage small pharmaceutical company in the Bay Area who are looking to expand the Quality group with the addition of a Clinical Quality Associate Director/Director. Based in either the San Bruno office, or Canada, my client is looking for a GCP compliance expert to join a tight- knit team oriented group to oversee all activities related to development and direction of the Global Clinical Quality strategy, objectives, policies and programs pertaining to development and marketing of drug products for a molecule. This company has multiple assets across Ps I- III and their lead product is due to start up Ph III in 2018.
This is a late-stage clinical pharmaceutical company based in San Bruno, California. This company is focused on developing therapeutic products that target anti-inflammatory diseases. A relatively new company to the Bay Area, this is role will have excellent potential for growth.
• Reporting to the Senior Director of Quality, serves as the lead on GCP compliance matters for the Company.
• Collaborates cross functionally to identify and implement GCP policy and procedures in compliance with GCP regulations/guidelines for managing clinical study programs.
• Provides Quality review and input to a variety of document types generated directly by internal Clinical staff and external CROs and other contract service providers.
• Acts as alternate in the absence of the Senior Director, Quality, on senior cross functional project teams.
• Partner with CROs and other contract service providers to assure risk-based GCP quality systems processes and procedures are deployed to the fullest extent possible.
• Assures clinical trials are conducted in accordance with study protocol requirements and in compliance with GCP and ICH guidelines and local requirements.
• Assures contracts with CROs and other clinical service providers activities are in compliance with applicable standards and regulatory requirements.
• Develops audit plans and conducts GCP compliance audits of investigator sites, CRO facilities, depots, and other clinical service providers for study-specific compliance as appropriate.
• Creates key quality metrics for tracking and trending data related to GCP activities, report metrics, and significant quality incidents to QA management.
• Conducts and coordinates GCP compliance training to internal and external customers as appropriate.
• Supports inspection readiness preparations (internal and external) and interactions with regulatory agencies during inspections on GCP related matters.
• Supports the continuous improvement and management of the Quality Systems.
• Minimum B.Sc. in a scientific discipline required.
• Must have 10 years of experience in GCP environment with at least 5+ years of experience in a Quality leadership role, preferably in late stage clinical research.
• Must have relevant auditing experience, both internal and external in the GCP environment.
• Experience in implementing and maintaining quality systems in a GXP environment.
• Experience with FDA and other health authority inspections.
• Extensive knowledge of US and EU GCP compliance regulations and industry practices, as well a working knowledge of ROW regulations
• This position will require a significant amount of travel (up to 35%) domestic and international.
Contact Mike Newman for an indepth discussion: +1 628 229 9022 or email firstname.lastname@example.org