Quality Project Manager

Irvine, CA (100% Onsite)

Pay Rate: $68.00 - $98.00/hour

Duration: 8 Months (Potential Extension or Conversion)

The Fountain Group is hiring a Manager, Quality Systems for a prominent pharmaceutical/medical device client in Irvine, CA. This is an excellent opportunity for a hands-on Supplier Quality professional with experience developing supplier scorecards, managing supplier quality agreements, and monitoring supplier performance within a regulated manufacturing environment.

Please Note: This is not a strategic or executive-level leadership role. The hiring manager is seeking a mid-level, hands-on quality professional who enjoys working directly with supplier quality systems and compliance activities.

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.
• Support supplier controls across pharmaceutical products, medical devices, biologics, cosmetics, and combination products.
• 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.

Required Qualifications

• 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.

Preferred Qualifications

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

What the Hiring Manager Is Looking For

• Hands-on Supplier Quality experience—not strategic program leadership.
• Experience building supplier scorecards from the ground up.
• Strong understanding of supplier quality metrics and performance management.
• Mid-level professionals with approximately 5-8 years of relevant Supplier Quality experience are ideal.
• Candidates with more experience are welcome if they have remained technically hands-on.
• Director-level or highly strategic leadership backgrounds are generally overqualified for this role.

Work 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.

If you're a Supplier Quality professional who enjoys working directly with supplier performance, quality agreements, and scorecard development in a regulated manufacturing environment, we'd love to hear from you.

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