Sr. Manager, Quality Operations

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Senior Quality Operations Manager is responsible for establishing and leading the Quality Operations function including the implementation of a sustainable Quality ontheShopFloor program that ensures product quality regulatory compliance and operational excellence. The role provides strategic and operational leadership for Quality Operations including workforce planning performance management resource allocation and continuous improvement initiatives aligned with site and corporate quality Senior Manager Quality Operations leads a team of direct reports and exercises independent judgments in matters affecting manufacturing quality compliance and operational performance. The role serves as a key partner to Operations Engineering Quality Control and other functions by providing direction on quality risks manufacturing issues investigations and compliance-related decisions to support a compliant and efficient manufacturing DUTIES AND ROLE RESPONSIBILITIESDepartment Leadership & People Management Defines and implements a Quality Operations ProgramLeads and manages the Quality Operations department including a team of direct department goals establishes annual performance expectations and ensures alignment with site strategy and regulatory hiring interviews recommends selection decisions and provides direct input on hiring and firing decisions that carry particular weight in final coaching disciplinary actions performance reviews training plans and developmental objectives for all direct Quality Operations staff maintain qualifications follow compliance expectations and consistently execute responsibilities with independence and Decision Authority RealTime Manufacturing OversightServes as the primary quality decision-maker for manufacturing issues and inprocess control realtime direction to Quality ontheFloor on quality pathways and risk escalated issues independently determining containment documentation and corrective actions required to maintain Deviations CAPA & Compliance GovernanceOversees the quality of all minor deviations investigations and CAPA records generated during the manufacture of product to ensure regulatorycompliant rootcause analysis timely closures and adequate effectiveness systemic issues and drive cross-functional corrective actions that influence Production Engineering Validation QC and Supply significant compliance risks to senior leadership with recommended paths Inspection and External Interface LeadershipServes as a technical lead and departmental representative during regulatory inspections and customer a constant state of audit readiness through periodic internal audits metric reviews and process confirmation Excellence & Quality Systems ImprovementLeads quality improvement initiatives using Lean Six Sigma and structured problemsolving methodologies targeting enhancement of manufacturing site compliance programs and support training on strategy improvements as they related to the manufacturing implements and monitors Quality Operations KPIs to improve system performance prevent recurrence of issues and support strategic Planning Budgeting & CrossFunctional LeadershipOwns department resource plans and coordinates staffing decisions through S&OP demand and delivers the Quality Operations budget including personnel tools training and equipment in strategic meetings steering committees and cross-functional leadership forums to influence manufacturing quality and business QUALIFICATIONSEducationBachelors degree or higher in Engineering Life Sciences or a related technical 10 years in a pharmaceutical medical device or similarly regulated manufacturing 7 years managing technical staff (quality engineering or manufacturing) including demonstrable experience leading teams of 3 involvement in hiring disciplinary actions and termination & Leadership SkillsDeep expertise in GMP manufacturing processes quality systems deviation/CAPA and equipment/process to make independent technical decisions that impact compliance product quality and customer communication skills with the ability to represent site quality operations to senior management regulatory inspectors and external in Lean/Six Sigma methodologies and data-driven decisionmaking.#LI-Onsite