Quality Control Manager M/F (28983)

 

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'RE LOOKING FOR:

The Quality Control (QC) Manager will be responsible for leading a team that oversees all aspects of quality control at the Raleigh facility.  The duties and responsibilities will 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 QC 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). This position is located at our Raleigh, NC site.

YOUR ROLE:

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

• Responsible for Quality Record management (OOSs, deviations, change controls, CAPAs), LIMS administration, Capital Project Management, Analytical Validation, Reference Standard Certification, and Stability Program management.

• 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.

• Provide overall direction, activities and function as the authority and expert on chemistry and microbiology strategy, procedures and techniques, and regulatory compliance.

• Active leader and decision-maker on internal projects related to formulation, filling, environmental monitoring, facility improvements and developing anew approach to business.

• Strong leadership skills, the ability to prioritize, multitask multiple projects, and work efficiently in a dynamic manufacturing environment.

• Support data integrity through data review, investigations, and close collaboration with site Data Integrity Steward.

• Perform administrative duties associated with managing a department and staff.  (i.e.  establish group goals, and reviews)

• Strong mentoring skills and a track record of developing others

• Identify quality issues, and in conjunction with QA Managers, recommend and implement corrective and preventative actions.

• Strong organizational skills

• Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.

 

YOUR BACKGROUND:

Education

• BA/BS in chemistry, biology, microbiology and/ or life sciences

Experience

• Minimum 8 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience

• Previous management level experience

Skills/Qual