Quality Control Manager

Sr. Manager Quality ControlBusiness: Pharma Solutions Department: Analytical Quality Control (AQC) Location: LexingtonJob OverviewReporting to the Director of Quality, the Sr. Manager, Quality Control has responsibility for the Analytical and Microbiology Quality Control (AQC/MQC) laboratories. The position will provide strategic direction and leadership to improve quality, efficiency, process standardization, and capabilities of the Quality Control Department.Reporting StructureThis position reports to the Director of Quality.Key Responsibilities:Direct oversight of activities performed within Quality Control LaboratoriesMonitor revenue goals ensuring that Laboratories meet or exceed expectationsDevelop and manage department budgetsRegularly monitor applicable internet and written information published by US FDA, EMA, PMDA, Other Applicable Agencies as required, and pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operationsEstablish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followedOversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibrationEstablish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirementsOversee all quality investigations within the departments (deviations, CAPA and LIR)Ensure Lab is a constant state of compliance and Sustains Permanent Inspection Readiness (PIR)Ensure suitable laboratory safety procedures are in placeEnsure that there is a department training program in place so that department staff are continuously developing and are current with industry practiceEnsure that department technical expertise and capabilities are constantly evolving and current with industryProvides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiriesAnalyse and trend sample results and perform statistical studies and evaluations of key performance indicatorsDevelop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needsServe as liaison with the corporate data, documentation, and review centerInteract directly with project managers, clients, consultants, and regulatory agenciesOversee the development, execution and implementation of quality improvement plans within the QC DepartmentOversee the identification, procurement, qualification and implementation of new laboratory equipment, and software platforms (i.e. LIMS, Empower, etc.) as neededPerform gap assessments and implement CAPAs as neededSupport internal and external audits, agency inspections, responses and CAPAsSupport Cross Functional Quality and Operational activities/projects as neededCreate and support an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safetyLead and develop/mentor QC membersAssign department resources so that company goals/timelines are achievedQualifications:B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferredMinimum of ten (10) years' progressive experience in a regulated cGMP industry is required, with five (5) years' management experienceMust have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plusStrong/demonstrated knowledge of cGMP regulationsPossess excellent technical writing and oral communication skillsSix Sigma Green Belt, Benchmarking and Project Management experience preferredAbility to travel as needed