The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing, and Controls
(CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
Syner-G Pharma Consulting is seeking a talented Associate Director of Clinical Quality Assurance in Quality Compliance with 10+ years of experience working in Clinical Quality Assurance in a Biotech or Pharmaceutical FDA regulated industry. The Clinical QA Associate Director is responsible for conducting audits to assess compliance with applicable regulations, company policy, and standard operating procedures, and project-specific requirements. The Quality Assurance Associate Director is a seasoned professional who has significant expertise in GCP requirements and extensive experience in conducting the various types of GCP and Pharmacovigilance audits.
- Plans, schedules, conducts, and closes assigned audits.
- Develops audit plans and applies a risk-based approach to auditing while audit planning
- Writes and issues audit reports, ensuring clear communication of audit findings to the auditee and management.
- Reviews responses to audit findings for appropriateness and completeness.
- Serves as Lead Auditor on team-based audits.
- Provides consultation to customers and monitors in the interpretation of audit observations, and formulation of the corrective action plan.
- Reviews root cause analysis, CAPA, and effectiveness check plans.
- Requires minimal instructions on day-to-day work and new assignments.
- May provide training to Syner-G personnel on quality-related matters.
- Performs other work-related duties as assigned.
- Moderate travel may be required to conduct audits.
- Bachelors or master’s degree in life sciences or a technical discipline and expertise in various aspects of GCP auditing.
- Pharmacovigilance auditing experience is preferred
- Previous experience in conducting multiple audit types (e.g., Vendor, investigator sites, trial master files, data management, safety reporting, and laboratories) is essential.
- Excellent knowledge of GCP and GPV regulatory requirements.
- Knowledge of medical and technical terminology related to audit types to be conducted.
- Able to handle multiple tasks to meet timelines in a dynamic environment.
- Good communication skills and ability to write concise accurate reports and other necessary documents.