Job Title:QA Consultant (GCP Compliance)
Location:Remote with potential travel to company sites as needed.
Hours/Schedule: 20hrs/wk for first few months, then transitioning to 40hours/wk as time goes on
Compensation: Open to discuss, depending on experience
Contract Length:3-6 months, with potential for extension based on project needs.
Overview:
We are seeking an experienced QA Consultant to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical Practice (GCP) compliance. The ideal candidate will have a deep understanding of GCP regulations and extensive experience guiding companies through FDA submission readiness, ensuring documentation, processes, and practices meet all regulatory requirements.
Key Responsibilities:
- Reviewing GCP operations and documentation to support regulatory filing (NDA submission)
- Supporting inspection readiness by assessing compliance with site, sponsor and provider (eclinical companies, biorepositories, clinical labs)
- Assess current QA processes and documentation for GCP compliance.
- Identify gaps and provide actionable recommendations to align with FDA requirements.
- Develop and implement SOPs, training programs, and corrective actions as needed.
- Conduct mock audits and prepare teams for potential audit scenarios.
- Review clinical trial data, monitoring processes, and vendor qualifications for adherence to GCP.
- Support the company in compiling and organizing audit documentation for FDA submission.
- Provide guidance during the audit process and help address any findings or concerns.
Qualifications:
- Bachelor's degree in Life Sciences or related field; advanced degree preferred.
- Minimum of 5 years of experience in QA with a focus on GCP and FDA audits.
- Proven track record of preparing small biotech or pharma companies for successful FDA inspections.
- Proven examples of gap assessments performed and remediated in advance of filing and inspection
- Strong understanding of FDA regulations, ICH guidelines, and GCP principles.
- Excellent communication skills and the ability to work effectively with cross-functional teams.
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