The successful 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.
Primary Duties and Responsibilities
Bachelor’s (BS) in the Life Sciences or related discipline.
- 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.
- Assesses internal and external CAPA plans to resolution.
- Assists in the development and processing of consultant auditor contracts and budgets, and reviews/approves contracted deliverables and invoices.
- Writes and reviews SOPs and other procedural documents, and provides guidance and training to ensure company-sponsored clinical trials and internal processes comply with applicable regulatory requirements.
- Reviews study plans and other documents related to phase 1 through phase 4 clinical trials, as needed, and provides QA guidance in the development of functional area processes.
- Reviews inspection findings (such as FDA 483s) for sites being considered for, or participating in, Ardea-sponsored clinical trials, and provides Clinical Operations with feedback from the reviews, for consideration in site selection and/or monitoring activities.
- Supports regulatory inspection readiness and follow-up activities, both external (ie, for sites participating in Ardea-sponsored clinical trials that are inspected by a regulatory authority) and internal (ie, for regulatory inspections of Ardea). Addresses, resolves and mediates corrective actions for inspection findings directed to Ardea, and prepares written reports as necessary; ensures training of internal staff as appropriate.
- Assists with developing, administering, and/or coordinating annual or ad hoc GCP training.
- Assists with Computer Systems validation projects by reviewing protocols, tests scripts and reports, if needed.
- Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
- Other duties as may be necessary.
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.
Strong writing skills in protocols, SOPs and QA reports.
Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail.
Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs.
The ability to work in a fast-paced and team environment.
This job may necessitate working outside “regular” work hours.
Some travel is required.
Ardea Biosciences - 17 months ago