NCBiotech
WHAT WE ARE LOOKING 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 improve where needed the QMS elements identified in the Summary of the Position
Ensure systems are compliant, efficient, and aligned with current regulatory expectations.
Lead periodic reviews and updates of SOPs, policies, and quality manuals.
Governance & Metrics
Work with Functional Area Leaders and OpEx to identify leading and lagging indicators and monitor the KPIs for quality system performance (e.g., change control cycle time).
Present quality metrics to senior leadership and recommend system improvements.
Chair or support the Change Control Review Board and Quality Governance meetings.
Audit & Inspection Readiness
Prepare for internal and external audits, including FDA and EU inspections.
Lead audit response efforts and ensure timely closure of observations.
Maintain a state of continuous inspection readiness.
Cross-Functional Collaboration
Partner with Manufacturing, Validation, Regulatory Affairs, and R&D to ensure quality systems are integrated and effective.
Provide quality oversight for new product introductions, tech transfers, and process changes.
YOUR BACKGROUND
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
Core Competencies:
Strategic thinking with operational discipline
Risk-based decision-making
Collaborative leadership and stakeholder engagement
Continuous improvement mindset
Documentation excellence and regulatory fluency
Physical Requirements:
Ability to lift up to 35lbs. without assistance
WHY 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 3000 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 horizons.
Do you want to help improve patients’ lives with us?
We look forward to meeting you and continuing our story together!
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is a signatory of the Diversity Charter.
We believe diversity is a source of strength, and all our positions are open to everyone.
Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.
Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.
Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
Equal Employment Opportunity Statement #J-18808-Ljbffr
YOUR ROLE Quality System Oversight
Own, maintain and improve where needed the QMS elements identified in the Summary of the Position
Ensure systems are compliant, efficient, and aligned with current regulatory expectations.
Lead periodic reviews and updates of SOPs, policies, and quality manuals.
Governance & Metrics
Work with Functional Area Leaders and OpEx to identify leading and lagging indicators and monitor the KPIs for quality system performance (e.g., change control cycle time).
Present quality metrics to senior leadership and recommend system improvements.
Chair or support the Change Control Review Board and Quality Governance meetings.
Audit & Inspection Readiness
Prepare for internal and external audits, including FDA and EU inspections.
Lead audit response efforts and ensure timely closure of observations.
Maintain a state of continuous inspection readiness.
Cross-Functional Collaboration
Partner with Manufacturing, Validation, Regulatory Affairs, and R&D to ensure quality systems are integrated and effective.
Provide quality oversight for new product introductions, tech transfers, and process changes.
YOUR BACKGROUND
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
Core Competencies:
Strategic thinking with operational discipline
Risk-based decision-making
Collaborative leadership and stakeholder engagement
Continuous improvement mindset
Documentation excellence and regulatory fluency
Physical Requirements:
Ability to lift up to 35lbs. without assistance
WHY 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 3000 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 horizons.
Do you want to help improve patients’ lives with us?
We look forward to meeting you and continuing our story together!
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is a signatory of the Diversity Charter.
We believe diversity is a source of strength, and all our positions are open to everyone.
Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.
Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.
Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
Equal Employment Opportunity Statement #J-18808-Ljbffr