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Director of Quality Assurance
1 month ago
SAGA Diagnostics is a pioneering company in personalized cancer diagnostics and disease monitoring, leveraging molecular genetic analysis of circulating tumor DNA (ctDNA) to revolutionize cancer treatment.
We are seeking a highly motivated and experienced Director of Quality Assurance to join our global Quality Assurance team, ensuring compliance with regulatory requirements and driving quality excellence across our operations.
The ideal candidate will have a strong background in quality management, with extensive experience in the diagnostics industry and a proven track record of ensuring regulatory compliance.
Key Responsibilities:
- Audit Preparation and Management
- Stay up-to-date with changes in regulations and standards, and implement necessary updates to QA processes.
- Plan, conduct, and oversee internal and external audits to ensure compliance with regulatory standards.
- Manage audit findings, develop corrective action plans, and ensure timely resolution of any issues.
- Perform vendor audits, as needed.
- Quality Assurance Oversight
- Ensure compliance with relevant regulatory requirements, including CAP/CLIA, NYS, GCP/GCLP.
- Conduct company-wide trainings as necessary to ensure others are upholding necessary regulatory standards.
- Investigate instances of nonconformances and CAPAs.
- Departmental Performance and Growth
- Participate in the development of Quality strategic plans and programs aligned with the company's objectives to ensure quality and compliance performance.
- Monitor and report quality metrics and performance indicators to improve product quality and process efficiency.
- Prepare and present regular reports on QA activities, performance metrics, and improvement initiatives to management.
- Collaborate with cross-functional teams to integrate quality assurance into all phases of product development and production.
Requirements:
- Minimum Master's degree in a relevant scientific discipline or equivalent.
- Minimum of 10 years of experience in quality assurance in CLIA/CAP high-complexity laboratory.
- Regulatory compliance knowledge including CLIA, CAP, NYS, state requirements, GCP/GCLP, 21 CFR Compliance and ISO 13485.
- Extensive experience managing regulatory inspections.
- Strong interpersonal skills including ability to communicate effectively with people individually and in groups; ability to communicate with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers.
- Ability to multi-task, shift priorities, and work in a fast-paced environment.
- Detail oriented, well organized and ability to find the simple solutions.
Benefits:
- The opportunity to develop cutting-edge automation solutions for genomic diagnostics.
- Generous benefits package including medical, dental, vision, FSA, HRA, and paid parental leave.
- Membership to SAGA's Equity scheme.
Primary location: Morrisville, North Carolina
SAGA Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background.
