QA Systems Manager

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Continued personal development

Diversity and inclusion initiatives

Job summary

Guerbet in Raleigh, North Carolina is seeking a Quality Systems Manager to oversee the execution and continuous improvement of its Quality Management System (QMS). The successful candidate will ensure compliance with global regulatory standards while driving a culture of quality throughout the organization.

The role requires at least 7 years in pharmaceutical QA, including 3 years in leadership, along with a Bachelor's degree in a relevant field. Join Guerbet and contribute to enhancing patient outcomes through innovation.

Qualifications

• 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.

Responsibilities

• Oversee the execution and continuous improvement of Guerbet's Quality Management System (QMS).
• Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ANVISA, PIC/S).
• Drive a culture of quality across the organization.

Skills

Analytical skills

Organizational skills

Communication skills

Understanding of GMP regulations

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

Electronic QMS platforms

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

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.

YOUR ROLE

Quality System Oversight

• 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.

Governance & Metrics

• 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.

Audit & Inspection Readiness

• 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.

Cross-Functional Collaboration

• Partner with Manufacturing, Validation, Regulatory Affairs, R&D, and other stakeholders to ensure effective integration of quality systems.
• New product introductions (NPI)
• Technology transfers
• Process and system changes
• Performs other duties as assigned by management

Department Specific/Non-Essential Functions:

• 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

YOUR BACKGROUND

Required Qualifications

• 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.

Preferred Qualifications

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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717