Enterprise QA Leader: ISO & Cleanroom Excellence

Prudential Overall Supply Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

401(k) with company match

Profit sharing

Medical, dental, and vision insurance

Paid time off

Tuition reimbursement available

Monday–Friday work schedule

Job summary

Prudential Overall Supply is seeking an experienced Quality Assurance Manager to lead and advance our enterprise QMS across all ISO-certified facilities nationwide. This role will uphold aseptic, sterile, and cleanroom-controlled environments and ensure audit readiness.

You will mentor plant QA teams, partner with Operations and Engineering, and drive CAPA processes. Travel nationwide ~30% is required; a Life Science background and 10+ years in QA are highly valued.

Qualifications

• Bachelor's degree in Life Science or related field required.
• Minimum of 10 years of Quality Assurance experience in pharma/biotech/medical device or cleanroom laundry operations.
• Experience supporting ISO-certified quality systems across multiple sites.
• Strong audit-facing experience with customers and certification bodies.
• Ability to travel approximately 30% nationwide.

Responsibilities

• Lead the enterprise QMS across ISO-certified facilities.
• Ensure compliance with ISO standards and customer requirements in aseptic environments.
• Represent quality in internal, ISO, and customer audits.
• Analyze quality data, trends and risks; implement CAPA.
• Develop and update QA programs, procedures, and practices.
• Partner with Operations, Engineering, and other teams to standardize quality practices.
• Mentor QA staff and plant-level leadership nationwide.
• Interface with vendors to support supply quality.
• Travel to plant locations nationwide to provide quality leadership and training.

Skills

Quality Assurance leadership

Audit management

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 and advance our enterprise QMS across all ISO-certified facilities nationwide. This role will uphold aseptic, sterile, and cleanroom-controlled environments and ensure audit readiness.

You will mentor plant QA teams, partner with Operations and Engineering, and drive CAPA processes. Travel nationwide ~30% is required; a Life Science background and 10+ years in QA are highly valued.