Quality Control Manager - Raleigh North Carolina

Company: Guerbet
Location: Raleigh, North Carolina
Posted On: 05/03/2024

At Guerbet, we build lasting relationships so that we enable people to live better.We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.Achieve, Cooperate, Care,andInnovateare the values that we share and practice.For more information on Guerbet, go towww.guerbet.comand 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 othersIdentify quality issues, and in conjunction with QA Managers, recommend and implement corrective and preventative actions.Strong organizational skillsKnowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.YOUR BACKGROUND:EducationBA/BS in chemistry, biology, microbiology and/ or life sciencesExperienceMinimum 8 years pharmaceutical experience/laboratory management and/or related pharmaceutical experiencePrevious management level experienceSkills/QualifcationsThorough knowledge of cGMPs, GLPs, and pharmaceutical manufacturing requirements.Demonstrated auditing and corrective action proficiency.Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.Demonstrated proficiency in root cause analysis as applied in a pharmaceutical manufacturing environment.Excellent problem solving and decision-making skills.Ability to manage and drive changeSix Sigma Greenbelt certificationSupervisory skillsComputer skillsKnowledge of document management/quality systemsby Jobble More...

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