Some responsibilities include:
• Represents QA and interfaces with multiple departments and external providers to provide GCP guidance in an effective, constructive and timely manner.
• Provides interpretation and consultation to project teams on regulations, guidelines, compliance status and policies and procedures.
• Trouble-shoots and takes the initiative on any QA-related issue for GCP compliance and monitors through resolution.
• Assists in GCP QA audit program management and infrastructure development. This includes administrative tasks such as set up and maintenance of audit database and files, and development of GCP QA working practice guidelines.
• Develops GCP QA trial-specific audit plans.
• Coordinates, oversees, and/or conducts external and internal GCP audits to ensure compliance with applicable regulations, guidelines, protocols, and Standard Operating Procedures (SOPs). This may include audits of investigational sites, clinical study reports, clinical databases, investigational product reconciliation, clinical development vendors (e.g., CRO’s, clinical laboratories, etc.), and internal audits of Clinical Operations, Regulatory, Biostatistics, and Data Management.
• Writes and reviews Audit Reports, and provides recommendations for corrective and preventative actions (CAPA) as necessary.
Some Requirements include:
• Bachelor’s (BS) in the Life Sciences or related discipline.
• At least six to eight years’ demonstrated experience in the GCP responsibilities listed above.
• Strong knowledge of GCP regulations and good documentation practices.
• Past experience working in clinical development is preferred.
• Extensive knowledge of biotechnology research and development processes and regulatory environments.