Quality Assurance System Manager

Guerbet; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet seeks an experienced Quality Systems Manager to lead the QMS within a regulated pharmaceutical manufacturing environment in the United States. You will oversee change control, document management, training, data integrity, supplier quality, APQR, and risk management, ensuring compliance and continuous improvement.

You will partner with Manufacturing, Validation, Regulatory Affairs, R&D and Operational Excellence to align quality systems with business needs and drive sustainable

Qualifications

• 7+ years of pharmaceutical QA/quality assurance experience.
• 3+ years of Quality Systems leadership experience.
• Strong knowledge of cGMP, 21 CFR Parts 210/211, EU GMP, ICH Q10.

Responsibilities

• Lead the execution and continuous improvement of the QMS.
• Oversee change control, document management, training, data integrity, supplier quality, APQR, and risk management.
• Prepare for internal audits and regulatory inspections and coordinate CAPA closures.
• Collaborate with Manufacturing, Regulatory Affairs, R&D, and Ops to integrate QMS across site operations.
• Develop and mentor Quality Systems team members.

Skills

Quality Systems Leadership

cGMP Knowledge

Regulatory Inspections

Data Integrity

Cross-functional Collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Pharmacy

Tools

eQMS

Job description

Guerbet is seeking an experienced Quality Systems Manager to lead the execution, governance, and continuous improvement of our Quality Management System (QMS) within a regulated pharmaceutical manufacturing environment.

In this highly collaborative leadership role, you will provide oversight of key quality systems, including change control, document management, training, data integrity, supplier quality, Annual Product Quality Reviews (APQR), quality risk management, and inspection readiness. You will work closely with Manufacturing, Validation, Regulatory Affairs, R&D, Operational Excellence, and other site functions to ensure quality systems remain effective, compliant, and aligned with business needs.

The ideal candidate brings strong pharmaceutical Quality Systems experience, an in-depth understanding of cGMP requirements, and the ability to develop people, influence cross-functional teams, and drive sustainable improvements across the organization.

YOUR ROLE

Quality Systems Leadership

• Lead the execution, oversight, and continuous improvement of assigned Quality Management System (QMS) processes.
• Ensure quality systems remain compliant, effective, efficient, and aligned with applicable regulatory requirements and company standards.
• Provide leadership and subject matter expertise across key QMS areas, including:
• Change control
• Document management
• Training systems
• Data integrity
• Supplier Quality Management
• Annual Product Quality Reviews (APQR)
• Quality Risk Management
• Audit and inspection readiness
• Lead periodic review and revision of SOPs, policies, procedures, and other controlled quality documentation.
• Identify opportunities to strengthen QMS effectiveness, standardization, compliance, and sustainability.
• Coach and develop direct reports while building strong Quality Systems capabilities across the team.

Quality Governance, Metrics & Continuous Improvement

• Establish, monitor, analyze, and communicate meaningful Quality KPIs and performance indicators.
• Identify trends, risks, recurring issues, and opportunities for continuous improvement.
• Present Quality System performance and recommendations to site and senior leadership.
• Lead or support Quality Governance forums, including Change Control Review Board activities.
• Partner with Operational Excellence and functional leaders to improve Quality System performance and process effectiveness.
• Use data and risk-based decision-making to prioritize improvement opportunities.
• Support implementation and optimization of digital and electronic QMS solutions.

Audit & Inspection Readiness

• Lead Quality Systems preparation for internal audits and regulatory inspections.
• Maintain a continuous state of inspection readiness across assigned Quality Systems.
• Serve as a Quality Systems subject matter expert during regulatory inspections and audits.
• Coordinate responses to Quality System observations and ensure appropriate corrective and preventive actions are established and completed.
• Monitor CAPA commitments arising from audits or inspections to support timely and effective closure.
• Apply lessons learned from inspections, audits, industry trends, and regulatory expectations to strengthen the QMS.

Cross-Functional Quality Partnership

• Partner with Manufacturing, Validation, Regulatory Affairs, R&D, Operational Excellence, and other functions to ensure Quality System requirements are effectively integrated into site operations.
• Provide Quality Systems oversight and support for:
• New Product Introductions (NPI)
• Technology transfers
• Manufacturing and process changes
• Equipment and system changes
• Site improvement initiatives
• Provide risk-based Quality guidance to teams evaluating significant business, process, and system changes.
• Facilitate effective communication and decision-making between Quality and operational stakeholders.
• Support regulatory submissions and other compliance activities as a Quality Systems SME when required.

Supplier Quality & Quality Risk Management

• Support the governance and continuous improvement of Supplier Quality Management processes.
• Ensure supplier-related Quality activities are appropriately documented, assessed, monitored, and escalated when necessary.
• Promote effective application of Quality Risk Management principles throughout the organization's QMS.
• Facilitate risk-based evaluation of Quality and compliance issues and help cross-functional teams establish appropriate mitigation strategies.
• Lead, coach, and develop Quality Systems team members.
• Establish clear objectives, priorities, and performance expectations.
• Build technical capability and support professional development among direct reports.
• Foster a culture of quality, accountability, collaboration, continuous improvement, and inspection readiness.
• Influence stakeholders across functions and organizational levels to drive Quality System improvements.

YOUR BACKGROUND

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Pharmacy, or a related scientific or technical discipline.
• 7+ years of progressive Quality Assurance experience within the pharmaceutical industry.
• 3+ years of Quality Systems leadership experience.
• Demonstrated experience managing or providing significant oversight of pharmaceutical Quality Management Systems.
• Strong working knowledge of cGMP requirements, 21 CFR Parts 210 and 211, applicable EU GMP requirements, and ICH Q10.
• Hands-on experience with multiple Quality Systems such as change control, CAPA, document management, training, data integrity, supplier quality, APQR, and Quality Risk Management.
• Demonstrated experience supporting and/or leading regulatory inspections and Quality audits.
• Strong experience analyzing Quality metrics, identifying trends, and driving corrective or continuous improvement initiatives.
• Proven ability to work effectively across functional areas in a regulated manufacturing environment.
• Strong written, verbal, analytical, organizational, and presentation skills.

Preferred Qualifications

• Master's degree, MBA, Ph.D., or other relevant advanced degree.
• Experience with electronic Quality Management Systems (eQMS).
• Experience within sterile pharmaceutical manufacturing and/or biologics.
• Lean or Six Sigma certification or demonstrated continuous improvement experience.
• Experience with Quality System digitalization, implementation, or optimization projects.
• Experience with supplier quality, data integrity, and APQR programs.
• Previous experience developing and leading Quality Systems professionals.