The successful GCP QA Manager/Senior Associate candidate will provide consultation in interpretation of GCP regulations, guidelines, policies, and procedures; plan and conduct independent Good Clinical Practice (GCP) quality assurance (QA) audits to assess compliance with regulations, training programs, documentation review, guidelines, and operating procedures; evaluate non-conformities and report findings; support GCP QA infrastructure development activities; support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
For more Information on Job Responsibilities and Requirements - Interested parties apply today at: www.ardeabio.com/careers
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.