GCP Compliance Manager

About the role

Manages and conducts GCP-related audit activities to support sponsors' Development portfolio and priorities. Analyzes and provides audit trending information for process improvement initiatives. Provides GCP advice and support to Clinical Development teams, as appropriate. Uses extensive experience to provide a high level of expertise in GCP requirements, with the ability to interpret regulations and guidance and apply them in the context of compliant execution of the most complex GCP-related activities and ad hoc advice servicing.

Responsibilities

• Develops, maintains and implements CQA Audit Plans to support Sponsor's most complex development projects and priorities
• Performs and/or manages GCP audits of Clinical Investigator sites, Clinical vendors, databases, documentation and associated GCP systems, as appropriate
• Ensures continuous improvement efforts are implemented
• Leads provision of GCP support during GCP-related 3rd party audits and inspections (e.g. Regulatory Authority Inspections, Business Partner audits, ‘due diligence’ support activities, etc.)
• Represents CQA on Sponsor's Clinical Project Teams, as appropriate, to provide GCP-related expertise and advice
• Uses experience to provide expertise in GCP requirements, with the ability to interpret regulations and guidance and apply them in the context of compliant execution of the most complex GCP-related activities and ad hoc advice servicing

Qualifications

• BS + 5 years as a GCP QA Auditor for a pharmaceutical company or CRO
• Previous experience in planning, conducting and reporting GCP audits of clinical investigator sites, clinical vendors and GCP related processes and documents from Phase I through Phase III