Director of Quality Assurance jobs in United States
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Metric Bio · 6 hours ago

Director of Quality Assurance

Metric Bio is a PE-backed CDMO seeking a Director of Quality Assurance to oversee QA operations. The role involves guiding continuous improvement initiatives and ensuring the integrity of quality systems and documentation.

Staffing & Recruiting
Hiring Manager
Enrico Caterina
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Responsibilities

Lead and develop QA team, driving quality culture and continuous improvement
Maintain quality systems, documentation, and validation activities
Manage investigations, CAPAs, audits, change control, and document control
Ensure compliance with cGMP, FDA, and EU requirements
Support internal/external audits and inspections
Report quality metrics and collaborate cross-functionally
Manage QA resources and support wider company initiatives

Qualification

GMP expertiseFDA complianceEU complianceQuality systems managementAnalytical skillsStandard software toolsProblem-solving skillsLeadershipCommunication

Required

Candidates need to be based within the US for consideration
Lead and develop QA team, driving quality culture and continuous improvement
Maintain quality systems, documentation, and validation activities
Manage investigations, CAPAs, audits, change control, and document control
Ensure compliance with cGMP, FDA, and EU requirements
Support internal/external audits and inspections
Report quality metrics and collaborate cross-functionally
Manage QA resources and support wider company initiatives
Strong GMP/aseptic expertise with experience in FDA/EU inspections
Influential communicator with strong analytical and problem-solving skills
Proven leader able to manage multiple priorities and build strong relationships
Proficient with standard software tools
Bachelor's degree in a scientific discipline
10+ years of GMP Quality experience; 5+ years in QA leadership

Preferred

advanced degree preferred

Benefits

Relocation support is provided!

Company

Metric Bio

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Utilizing our expertise to provide recruitment solutions to some of the worlds most cutting-edge companies in MedTech and Life Science.

Funding

Current Stage
Growth Stage
Company data provided by crunchbase