Manager, Quality Systems

Job Title: Quality Systems Manager

Location: Waukegan, IL 60085 or Irvine, CA 92612 (100% On-site initial expectation
- Relocation: No (Local candidates only))

On-site Expectation: The role requires being 100% on-site initially to establish workflow and performance. Hybrid flexibility may be evaluated and earned over time based on performance.

Duration: 9 Months (Extension based on performance and business needs)

Work Schedule: Monday - Friday, 40 hours/week

Travel: None

This role is not intended for director-level or highly strategic professionals. The hiring manager views this as a mid-level position rather than a senior leadership role.

Experience Level: Candidates with more than 20 years of experience will be considered, provided they remain hands‑on and have not primarily worked in highly strategic, executive-level, or leadership‑focused roles. The key consideration is alignment with the operational, execution‑focused nature of this position, not the total years of experience.

The Manager, Quality Systems is a mid-level, hands‑on operational role responsible for providing quality assurance support and ensuring regulatory compliance across pharmaceutical products, medical devices, combination products, and biologics. This is an evolving role within a team introducing new activities. The primary focus is to drive supplier quality performance management, manage quality agreements, and handle supplier metrics verification. The ideal candidate will translate quality strategy into tactical objectives, ensuring all processes from raw material inspection through final shipment comply with corporate and governmental regulations.

• Collect, organize, and analyze supplier performance data across multiple large supplier sites.
• Prepare and generate supplier‑specific scorecards to be used during supplier review discussions and performance evaluations.
• Perform supplier site metrics reviews and assessments to evaluate overall performance and drive accountability.
• Generate detailed reports to support data‑driven decision‑making related to supplier quality.

• Support the completion, coordination, and management of Quality Agreements with suppliers.
• Review, maintain, and manage quality agreement documentation, ensuring timely execution and compliance.
• Engage in verifying, tracking, and confirming that supplier sites complete their required metrics reviews within established timelines.

• Follow up actively with supplier sites to ensure compliance with scheduled quality activities.
• Communicate effectively with internal teams and cross‑functional supplier stakeholders to drive the completion of quality‑related tasks.
• Support various additional quality‑related activities, validation initiatives, and miscellaneous projects as needed by the team.

• Education: Bachelor’s degree (strongly preferred in Life Sciences; candidates with non‑life science degrees may be considered on a case‑by‑case basis if backed by exceptional experience).
• Experience: 5 to 8 years of hands‑on Quality experience within a heavily regulated Pharmaceutical, Medical Device, or Biologics environment (Candidates from outside these industries will not be considered).
• Core Expertise: Strong background in Supplier Quality / Supplier Controls
  , Quality Systems, and working with quality metrics/performance tracking.
• Communication: Excellent written and oral communication skills with strong relationship‑management capabilities.
• Attributes: High attention to detail, strong organizational/documentation skills, self‑motivated, and able to work independently in an evolving environment.

• Certifications: ASQ Certification (e.g., CQA, CQE).
• Systems: Experience using SAP (for gathering and analyzing supplier data),
  SolTRAQs / One Track / Track Wise
  , and Veeva Vault
  .
• Advanced Agreements
  
  Experience:
  
  Direct experience drafting, negotiating, and securing approvals for Quality Agreements.
• Process Knowledge: General understanding of change management, non‑conformances, or exception reporting (though direct ownership of change notifications is not required).

• Operational Focus: This is a strictly operational, hands‑on execution role. It is not a strategic, director-level, or people‑management position. Highly strategic executive profiles will not align with the day‑to‑day requirements.
• Project Management Clarity: Although categorized internally under a project management level, formal project management experience is not required. The focus remains strictly on supplier quality metrics and agreements.