QA Strategy Lead – Biotech & Medical Devices

Vetted Solutions; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Vetted Solutions is seeking a Quality Assurance Manager III to lead QA operations for biotechnology and pharmaceutical products. You will oversee quality systems, mentor the QA team, and drive CAPA investigations to ensure regulatory readiness.

The role demands strong leadership, robust knowledge of FDA/GMP/ISO, and collaboration with manufacturing, R&D, and regulatory teams to deliver safe, high-quality healthcare solutions.

Qualifications

• Proven leadership and team mentoring abilities.
• Strong knowledge of FDA, GMP, and ISO standards.
• Experience leading investigations and CAPA programs.
• Excellent cross-functional collaboration and communication.

Responsibilities

• Oversee quality systems to ensure FDA, GMP, ISO compliance.
• Manage and mentor a high-performing QA team.
• Drive investigations, CAPAs, and continuous improvement initiatives.
• Partner with manufacturing, R&D, and regulatory teams to ensure quality and compliance.
• Support audits and inspections to maintain regulatory readiness.
• Contribute to delivering safe, high-quality healthcare solutions.

Skills

Leadership

Regulatory compliance

CAPA investigations

Process improvement

Job description

Vetted Solutions is seeking a Quality Assurance Manager III to lead QA operations for biotechnology and pharmaceutical products. You will oversee quality systems, mentor the QA team, and drive CAPA investigations to ensure regulatory readiness.

The role demands strong leadership, robust knowledge of FDA/GMP/ISO, and collaboration with manufacturing, R&D, and regulatory teams to deliver safe, high-quality healthcare solutions.