Enterprise QA Manager — ISO, Cleanroom & Life-Science

RXinsider LTD.; Irvine, Northern (CA, KY); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Prudential Overall Supply is seeking an experienced Quality Assurance Manager to lead the enterprise QMS across all ISO-certified facilities nationwide. The role focuses on aseptic, sterile, and cleanroom environments, ensuring compliance and readiness for audits and certifications.

The candidate will drive CAPA programs, develop QA procedures, and partner with Operations and Engineering to standardize quality practices while mentoring QA teams and supporting supplier quality across multiple

Qualifications

• Bachelor’s degree in a Life Science discipline.
• 10+ years in Quality Assurance in pharma/biotech/medical device or cleanroom laundry.
• Experience leading ISO-certified QMS across multiple sites.
• Strong audit experience with customers and certification bodies.
• Willingness to travel ~30% nationwide.

Responsibilities

• Lead, implement, and improve the enterprise QMS across ISO facilities.
• Ensure ISO compliance and audit readiness; manage CAPA.
• Develop QA programs and operating procedures.
• Collaborate cross-functionally with Operations and Engineering.
• Mentor plant QA leadership and quality teams.
• Provide travel to plant locations for coaching and audits.

Skills

Quality leadership

Auditing

CAPA

ISO compliance

Cross-functional collaboration

Education

Bachelor’s degree in Life Science or related field

Job description

Prudential Overall Supply is seeking an experienced Quality Assurance Manager to lead the enterprise QMS across all ISO-certified facilities nationwide. The role focuses on aseptic, sterile, and cleanroom environments, ensuring compliance and readiness for audits and certifications.

The candidate will drive CAPA programs, develop QA procedures, and partner with Operations and Engineering to standardize quality practices while mentoring QA teams and supporting supplier quality across multiple