GCP QA Manager/Sr. Associate

Organization: 
Ardea Biosciences/AstraZeneca
Job Location: 
San Diego, CA
Job Description: 

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.

Requirements: 

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.

Contact Information: 

Interested parties please apply on-line at: www.ardeabio.com/careers

About Our Organization: 

Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego, CA is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases. Ardea is seeking a GCP QA Manager/Senior Associate to join its’ dynamic team.