Quality Project Manager

Responsibilities

• Develop, maintain, and analyze supplier quality scorecards and performance metrics.
• Create, review, and support Supplier Quality Agreements (SQAs).
• Track, trend, and report supplier quality performance and compliance metrics.
• Monitor supplier performance and partner with suppliers to drive quality improvements.
• Ensure supplier quality activities comply with FDA, GMP, and corporate quality requirements.
• Maintain supplier quality documentation and quality system records.
• Utilize quality systems including SAP and other quality management platforms.
• Collaborate with Quality, Manufacturing, Regulatory, and Supply Chain teams to support supplier compliance initiatives.

Requirements

• Bachelor's degree in Life Sciences or a related scientific field.
• 8+ years of Quality experience within the pharmaceutical and/or medical device industry.
• Strong experience in Supplier Controls.
• Experience developing supplier scorecards.
• Experience tracking and trending supplier quality metrics.
• Experience creating or managing Supplier Quality Agreements.
• SAP experience.
• Excellent written and verbal communication skills.

Qualifications

• Hands-on Supplier Quality experience.
• Experience building supplier scorecards from the ground up.
• Strong understanding of supplier quality metrics and performance management.

Skills

• Experience with SolTraqs (strongly preferred).
• Experience with OneTrack.
• Experience with Veeva Vault.
• ASQ Certification.
• Experience supporting FDA-regulated manufacturing environments.

Pay

$68.00 - $98.00/hour

Schedule

Monday-Friday, 40 hours per week
100% onsite in Irvine, CA
Potential opportunity to transition to a hybrid schedule after demonstrating strong performance.
No travel required.

Additional Information

Local Southern California candidates are strongly preferred.
Relocation candidates will generally not be considered.
Experience within pharmaceutical and/or medical device manufacturing is required.