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

The Candidate:

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.

Primary Responsibilities

  • 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.

Required Experience:   

  • 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.
Job Category: Director
Job Type: Full Time

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