Enterprise Quality Assurance Leader - ISO & Audits

Prudential Overall Supply Inc.; Irvine (CA); On-site; USD 125,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

401(k) match

Comprehensive benefits

Paid time off

Tuition reimbursement

Weekday schedule

Career development

Job summary

Prudential Overall Supply is seeking an experienced Corporate Quality Assurance Manager to lead and advance our enterprise Quality Management System (QMS) across all facilities nationwide, with emphasis on ISO compliance, audits, and quality leadership in cleanroom and life-science services.

This role requires a life-science-related degree and 10+ years of QA leadership, plus strong audit-facing experience. Travel up to 30% nationwide to support sites and drive continuous improvement.

Qualifications

• Bachelor’s degree in Life Science or related field is required.
• 10+ years of Quality Assurance experience in relevant settings (pharma/biotech/medical devices or cleanroom laundry operations).
• Experience leading ISO-certified QMS across multiple sites and auditing with customers/certification bodies.
• Ability to travel approximately 30% nationwide.

Responsibilities

• Lead the execution, implementation, maintenance, and continuous improvement of the enterprise Quality Management System (QMS) across all ISO-certified facilities.
• Ensure compliance with ISO standards, internal quality policies, and customer requirements, with a focus on aseptic, sterile, and cleanroom-controlled environments.
• Serve as primary quality representative for internal audits, ISO certification audits, and customer audits, including preparation and closure of findings.
• Analyze quality data, trends, and risks; implement CAPA.
• Develop and update QA programs, procedures, and operating practices aligned with business objectives.
• Partner with Operations, Engineering, and other teams to standardize quality practices and drive improvement.
• Lead, mentor, and support Quality team members and plant-level QA leadership nationwide.
• Interface with vendors to support supply quality and adherence to standards.
• Travel to plant locations nationwide to provide quality leadership, coaching, and audit support.

Skills

Quality Assurance

ISO Standards

Audits

CAPA

Leadership

Travel 30%

Education

Bachelor’s degree in Life Science or related field

Job description

Prudential Overall Supply is seeking an experienced Corporate Quality Assurance Manager to lead and advance our enterprise Quality Management System (QMS) across all facilities nationwide, with emphasis on ISO compliance, audits, and quality leadership in cleanroom and life-science services.

This role requires a life-science-related degree and 10+ years of QA leadership, plus strong audit-facing experience. Travel up to 30% nationwide to support sites and drive continuous improvement.