Head of Quality Assurance
3 weeks ago
Job Summary
This position is responsible for leading the Quality team to ensure compliant processes, team management, and oversight of Quality compliance and operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO compliance requirements.
Key Responsibilities:
- Manage personnel and compliance for assay validation, clinical study development, and testing, IVD manufacturing, and overall Quality Systems.
- Implement and maintain quality metrics, systems, and documentation associated with clinical trials.
- Develop and conduct GxP, CLIA, IVD Manufacturing, and GCLP training across all lab areas.
- Manage, create, and ensure appropriateness of procedures related to Clinical Trials and IVDs.
- Serve as quality liaison with regulatory agencies and sponsors.
- Maintain state licenses for a CLIA medical laboratory and CAP and ISO accreditations.
- Manage staff to ensure timely delivery of assigned responsibilities.
- Provide quality assessment for assay/product validations.
- Establish and maintain Quality Systems to meet regulatory requirements.
- Oversee, host, and/or lead regulatory, sponsor, external vendor, and/or partner lab inspections/audits.
Requirements:
- Minimum of 12 years of progressively responsible experience in a related Quality Assurance role in a regulated environment.
- Minimum of 7 years of experience with clinical trials supporting GCLP.
- Minimum of 5 years of leadership and direct supervisory experience.
- CLS license desired.
- IVD experience desired (Companion Diagnostics).
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