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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Head of QC Lab - (Director)

Summary of Position

The Laboratory Manager will be responsible for leading a team that oversees all aspects of quality control at the Raleigh facility.  The duties of the Laboratory Manager cover all aspects of QC, including but not limited to oversight of the Chemistry and Microbiology Laboratories analysis of Raw Materials, Manufacturing In-process Samples, Finished Product, Stability Testing, and Environmental Monitoring.  Additionally, the Laboratory Manager leads the Lifecycle Management group, oversight of Compliance records, the Product Stability Program, LIMS administration, Analytical Validation, and global / site-level strategic capital projects.

Primary responsibilities include leading, mentoring, and developing the chemistry & microbiology laboratory personnel in support of a cGMP sterile parenteral manufacturing facility.  They are expected to lead by example and provide coaching to others in the areas of safety, quality, and Continuous Improvement/Lean methodologies (Lean Laboratory).  Candidate needs to be capable of processing large amounts of information to make sound decisions in order to meet regulatory requirements of various agencies: FDA, EU, MHRA and internal/site KPIs.  Must have a high degree of initiative to resolve problems, discuss and research actions to be taken, facilitate a “shared yes” across internal/external stakeholders, and ensure execution of solution(s).

Essential Functions

1.    Responsible for microbiology and chemistry laboratory operations consisting of 15 - 25 individuals on various shifts, with multiple shift supervisors reporting to them.

2.    Manages individual contributors who are responsible for Quality Record management (OOSs, deviations, change controls, CAPAs), LIMS administration, Capital Project Management, Analytical Validation, Reference Standard Certification, and Stability Program management. 

3.    Identify and implement internal KPIs relating to Safety, Quality, Operational Effectiveness, Financial Performance, and Training while facilitating a culture that drives the behaviors required to meet metrics and demonstrate the Guerbet values. 

4.    Provide overall direction, activities and function as the authority and expert on chemistry and microbiology strategy, procedures and techniques, and regulatory compliance.
5.    Active leader and decision-maker on internal projects related to formulation, filling, environmental monitoring, facility improvements and developing anew approach to business.
6.    Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic manufacturing environment. 
7.    Support data integrity through data review, investigations, and close collaboration with site Data Integrity Steward.
8.    Perform administrative duties associated with managing a department and staff.  (i.e.  establish group goals, and reviews)
9.    Strong mentoring skills and a track record of developing others
10.  Identify quality issues, and in conjunction with QA Managers, recommend and implement corrective and preventative actions.
 

Minimum Requirements

  • BA/BS in Chemistry, Biology, Microbiology, and or life sciences
  • Minimum 8 years in pharma experience/laboratory management and/or related pharma experience
  • Previous management level experience
  • Thorough knowledge of cGMPs, GLPs, and pharma manufacturing 
  • Demonstrated auditing and corrective and proficiency
  • Demonstrated proficiency in root cause analysis as applied in a pharma environment
  • Excellent problem solving, communication, and decision making skills
  • Computer skills, and knowledge of document management/quality systems