Prudential Overall Supply is seeking an experienced Quality Assurance Manager to lead and advance our enterprise Quality Management System (QMS) across all facilities nationwide. This role plays a critical part in supporting our cleanroom and life-science service offerings and will have broad responsibility for ISO compliance, audit readiness, and quality leadership across all laundry plants.

Key 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 strong focus on aseptic, sterile, and cleanroom-controlled environments.

· Serve as a primary quality representative for internal audits, ISO certification audits, and customer audits, including preparation, participation, and timely closure of findings.

· Analyze quality performance data, trends, and risks; develop and implement corrective and preventive actions (CAPA).

· Develop, implement, and update quality assurance programs, procedures, and operating practices aligned with business objectives.

· Partner cross-functionally with Operations, Engineering, and other teams to standardize quality practices and drive continuous improvement.

· Lead, mentor, and support Quality team members and plant-level QA leadership nationwide.

· Interface with vendors and suppliers, as needed, to support supply quality and adherence to quality standards.

· Travel to plant locations nationwide to provide quality leadership, coaching, training, and audit support.

Requirements

Qualifications

  • Bachelor’s degree in a Life Science discipline (e.g., Biology, Chemistry, Microbiology, Engineering, or related field) required.
  • Minimum of 10 years of Quality Assurance experience in one of the following:
  • Pharmaceutical, biotechnology, or medical device manufacturing in critical aseptic (sterile) environments, or
  • Quality Assurance leadership within cleanroom laundry operations.
  • Demonstrated experience supporting and leading ISO-certified quality systems in a multi-site or enterprise environment.
  • Strong audit-facing experience with customers and certification bodies.
  • Ability to travel approximately 30% nationwide.

Location

Address
Irvine
California
92606
United States

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