Germer International - Pharmaceutical Recruiting · 9 hours ago
Senior Quality Auditor/ Specialist- GCP
Connecticut, United States
Full-time
Onsite
Senior Level, Lead/Staff
$120K/yr - $140K/yr
8+ years expGermer International is seeking a Senior Quality Specialist with GCP experience to join a growing organization that values teamwork and positive impact. The role involves leading audits, ensuring compliance, and collaborating with management on corrective actions resulting from audits and inspections.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
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
Qualification
Required
BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries
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
Preferred
MS preferred
PhD with 3-6 plus years' experience
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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