QA Systems Manager

Laboratoire Guerbet • Raleigh, IL

1d

About The Position

The Quality Systems Manager will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Quality Systems Manager is responsible for overseeing the execution and continuous improvement of Guerbet's Quality Management System (QMS). This role ensures compliance with global regulatory requirements (e.g., FDA, EMA, ANVISA, PIC/S), supports GMP operations, and drives a culture of quality across the organization. The manager will lead cross-functional initiatives to enhance documentation, training, change control, Data Integrity, Supplier Management, APQR management, Risk Management, Supplier Quality and audit readiness. The incumbent will coach and develop their Direct Reports supporting the site's continuous improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 7+ years of experience in pharmaceutical QA, with 3+ years in quality systems leadership.
• Deep understanding of GMP regulations (21 CFR Parts 210/211, EU Annexes, ICH Q10).
• Proven experience managing audits and regulatory inspections.
• Strong analytical, organizational, and communication skills.

Nice To Haves

• Advanced degree (MS, MBA, or Ph.D.).
• Experience with electronic QMS platforms
• Six Sigma or Lean certification
• Experience in sterile manufacturing or biologics

Responsibilities

• Own, maintain, and continuously improve core Quality Management System (QMS) elements as defined in the role scope.
• Ensure QMS processes remain compliant, efficient, and aligned with current regulatory expectations (e.g., FDA, EU GMP).
• Lead periodic review and revision of SOPs, policies, and quality manuals to ensure accuracy and effectiveness.
• Collaborate with Functional Area Leaders and Operational Excellence (OpEx) to define and monitor leading and lagging quality performance indicators.
• Analyze key performance indicators (KPIs) (e.g., change control cycle time) and drive continuous improvement actions.
• Present quality system performance metrics to senior leadership with recommendations for improvement.
• Chair or support Quality Governance forums, including Change Control Review Board meetings.
• Lead preparation activities for internal audits and external regulatory inspections (FDA, EU, etc.).
• Oversee audit response processes, ensuring timely, thorough closure of observations and CAPAs.
• Maintain a continuous state of inspection readiness across the organization.
• Partner with Manufacturing, Validation, Regulatory Affairs, R&D, and other stakeholders to ensure effective integration of quality systems.
• Provide quality oversight for: New product introductions (NPI), Technology transfers, Process and system changes.
• Performs other duties as assigned by management.
• Support site-specific initiatives related to digital QMS tools or system implementations.
• Contribute to training program development for quality systems and compliance topics.
• Participate in or lead continuous improvement or Operational Excellence (OpEx) projects outside core QMS ownership.
• Provide support during regulatory submissions or inspections as a subject matter expert (SME), as needed.
• Assist in benchmarking or industry best practice evaluations to enhance QMS maturity.
• Support additional departmental projects or cross-site initiatives as assigned.
• Performs other duties as assigned by management.

Benefits

• Competitive salary
• Continued personal development

What This Job Offers

• Job Type: Full-time
• Career Level: Manager