Senior Quality Auditor​/Specialist- GCP

Our client is seeking a Senior Quality Specialist, who has GCP experience, to join a growing organization that values teamwork and positive impact. If you’re someone who wants to be part of making a difference, this could be the perfect opportunity for you!

Responsibilities

• Lead/manage the defined audits utilizing internal/external resources in a cost efficient and effective manner. Ensure post-audit activities entail timely follow-up and resolutions.
• Serve as GCP subject matter expert on teams
• Ensure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
• Review plans and materials for compliance, and contracts/proposals to ensure they adequately capture outsourced QA requirements.
• Collaborate with senior management and relevant stakeholders on corrective actions resulting from audits and regulatory inspections.
• Ensure pharmacovigilance activities including safety information processing and reporting follow regulations.
• Lead multiple key host roles for regulatory inspections and post inspection follow up and corrective action implementation.
• Lead / manage the quality support role for all post marketing studies
• Remain current on regulatory expectations and best practices

Education/Experience Requirements

• BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years’ experience or PhD with 3-6 plus years’ experience.
• Five years of Safety/GCP experience.
• Proficiency in understanding regulatory documents and the drug submission process.
• Proficiency in assessing data to ensure compliance with applicable GxP regulations and internal SOPs.