Quality Manager

DescriptionResponsibilitiesManage, plan, organize, direct, and evaluate all activities and QA staff to ensure that Quality support is present on the production floor and assistant in resolving compliance concernsComply with all company safety rules and workplace conduct requirementsInspect and test materials, equipment, processes and final products to verify compliance with quality standardsProvide strong leadership, project and people management skills, and critical decision-making abilitiesAssure a safe and non-discriminatory working environment for employeesEnsure compliance with manufacturing, specifications, and company policies. Ensure the departmental SOPs are current and staff are trained on relevant activitiesManages the supplier quality program to ensure cGMP compliance over vendors that provide materials/servicesEnsure GMP compliance of quality systems/tools used at the site including a quality manual, policies, procedures, and work instruction documentation that make up the hierarchy of the Document Control systemMaintains metrics program with measurables that achieve continuous improvements of processes and proceduresPrepare the department for both internal and external authorities during audits ensuring facility is always audit readyResponsible for change control activities/documentation in QMS. Required to perform review of submission documentsEnsure deviations and non-conformances are initiated, investigated, and closedSupport approval of manufacturing documents (SOP's/WI, Forms)Manage relationship with Third Party Testing Labs, Equipment Vendors and Calibration SuppliersDemonstrate a deliberate focus on Safety, Quality, Continuous Improvement, and Customer SatisfactionQualifications/Skills Required5 + Years' experience in pharmaceutical, packaging, or similar regulated industry2+ years direct/indirect supervisory experience and/or leading a team or processWorking knowledge of GMPs, ISO standards and production processesAbility to work autonomously applying strong problem-solving skillsStrong communication skills are needed to manage support personnelAbility to navigate through our ERP and QMS systems effectivelyAbility to work well with others and in a diverse workforce environmentMust be eligible to work in the United States without restrictionPhysical RequirementsSafely and effectively handle objects weighing between 15-20 pounds on a consistent basis, with the capability to lift up to 50 pounds when requiredMaintain good hand-eye coordination and manual dexteritySustain physical endurance for a fast-paced work environmentOperate and work near machinery safely