Quality Project Manager

The Fountain Group; Greer, San Francisco (SC, CA); On-site; USD 93,676 - 135,004; Full time

Job summary

The Fountain Group is seeking a hands-on Manager, Quality Systems in Irvine, CA to lead supplier quality activities in a regulated manufacturing environment. You will develop supplier scorecards, support SQAs, track performance, and ensure compliance with FDA/GMP requirements.

This 8-month, 100% onsite role is not strategic leadership; it targets mid-level professionals who remain technically hands-on while collaborating with Quality, Regulatory, and Supply Chain teams.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 8+ years of Quality experience within the pharmaceutical and/or medical device industry.
• 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.

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.

Skills

Supplier Quality

Quality Metrics

Vendor Management

Documentation

Education

Bachelor's degree in Life Sciences

Tools

SAP

SolTraqs

OneTrack

Veeva Vault

Job description

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.