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 QC Chemistry Manager is accountable for overseeing all Quality Control (QC) activities related to the:  incoming inspection of components, the release testing of raw materials, in-process sample testing, and the release and stability testing of sterile injectable and liquid oral products. The QC Manager ensures compliance with CGMP regulatory requirements, and the company’s quality standards. This role leads Incoming Inspection and Chemistry laboratory operations, manages QC personnel, aligns QC testing with company priorities, ensures data integrity, and supports batch release, investigations, and regulatory inspections.

The QC Chemistry Manager will design and/or improve the QC Chemistry laboratory’s systems to manage samples, standards, reagents, instrumentation, personnel, analytical methods, and data. This role is responsible for a budget to support the testing and maintain the QC Chemistry laboratory in a state fit for use. The role is accountable for tracking and reporting on the key leading and lagging indicators demonstrating the QC Chemistry laboratory’s compliance to CGMPs and Company priorities.

The QC Chemistry Manager will engage the chemistry laboratory personnel to build sustainable processes and systems that are continuously improved and provide sustainable compliance, reduced costs, and create a collaborative team.

The QC Chemistry Manager needs to be capable of processing large amounts of information and data to make sound recommendations and decisions in order to meet regulatory requirements of various Health Authorities (e.g., FDA, EMA, MHRA).

YOUR ROLE

• Leads and manages QC Incoming Inspection and chemical laboratory operations supporting manufacturing, investigations and company requirements as needed
• Ensures compliance with CGMP, FDA (and other regulatory requirements) and industry best practices
• Reviews and approves test results, analytical reports, certificates of analysis (COA), and batch release documentation
• Reviews and approves Out-of-Specification (OOS), Out-of-Trend (OOT), Exceptions (nonconformances), CAPAs, and Change Control related to QC Chemistry
• Ensures proper validation and qualification of analytical methods, instruments, and computerized systems used by the Chemistry Laboratory
• Supports regulatory inspections, audits, and customer audits
• Ensures data integrity (GDP and ALCOA+ principles) and compliance with 21 CFR Part 11
• Develops, reviews, and approves Standard Operating Procedures (SOPs), specifications, and protocols
• Provides overall direction, activities and function as the authority and expert on chemistry strategy, procedures and techniques, and regulatory compliance

Cross Functional Collaboration

• Coordinates with QC Microbiology, Planning, Manufacturing, QA, Engineering, and Regulatory Affairs teams

Governance and Metrics

• Manages QC Chemistry resources, budgeting, and continuous improvement initiatives
• Trains and mentors QC Chemistry staff to ensure technical competency and GMP awareness
• Identifies and implements internal KPIs relating to Safety, Quality, Operational Effectiveness, Financial Performance, and Training while facilitating a culture that drives the behaviors required to transform the laboratory into a learning-based culture
• Demonstrates strong leadership skills, the ability to prioritize, multitask multiple projects, and work efficiently in a dynamic manufacturing environment
• Performs administrative duties associated with managing a department and staff.  (i.e.  establish group goals, and reviews)
• Identifies quality issues, and in conjunction with QA Managers, recommend and implement corrective and preventative actions
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related life science
• Minimum 10 years Pharmaceutical Quality Control experience
• 5 to 10+ years of Pharmaceutical laboratory management, with at least 5 years in a supervisory or management role
• Thorough knowledge of CGMPs, GLPs, and Pharmaceutical manufacturing requirements
• Demonstrable record of successfully assessing and determining the impact of current and potential regulatory compliance issues
• Demonstrable proficiency in root cause analysis as applied in a Pharmaceutical manufacturing environment
• Excellent problem solving and decision-making skills
• Ability to manage and drive change in a dynamic environment
• Microsoft Office Suite-based Computer skills
• Knowledge of document management/quality systems

Preferred Qualifications

• Master’s degree in Pharmaceutical Sciences, Analytical Chemistry, or Quality Management

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 careers@guerbet.com or you can also call this number +19843443717