Manager, Quality Operations

Summary of Objective

Responsible for managing daily operations of the IQA Receiving and Quality Operations Departments through the activities of the Supervisors, Leads, Auditors and Inspectors. Responsible for the quality issues/events that occur on all shifts.

Essential Duties and Responsibilities

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands.
• Provide 24-hour support for Quality related issues either by phone or email.
• Be observant of processes, performance, and behaviors, focusing on continuous improvement.
• Manage budgets and plans for business growth.
• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First-Time metrics).
• Provide support via emails, phone, Quarterly Business Review/meetings, tours, audits, and investigations.
• Facilitate Annual Product Reviews. Deliver customer satisfaction.
• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
• Provide training and presentations to all associates as needed.
• Ensure headcount, staff and production demands are met.
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
• Responsible for developing, review and approve department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications and Forms.
• Responsible for facilitating troubleshooting issues for the department’s testing equipment and or work with vendors to resolve errors.
• Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards.
• Investigate root causes of quality events/defects and recommending solutions.
• Oversee functions of Incoming Quality Inspection and Quality Operations.
• Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).
• Manage Batch Record Right First-Time program.
• Ensure compliance for onboarding and training new Quality team members.
• Ability to partner and collaborate with functional departments.
• Order and or approve supply requisitions.
• Oversee Pest Control Program.
• Oversee Mean Kinetic Temperature and Environmental Monitoring. Primary Quality Contact for Business Units regarding operational issues.
• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments.
• Provide hands-on training ensuring employees are trained to quality functions.
• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
• Lead and drive improvement / harmonization initiatives across multiple facilities.
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion.
• Report and escalate to Senior Management of any potential risks that impact Quality.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance at work is an essential function of this position.
• Performs other duties as assigned by Manager.