Manager Quality Operations Jobs

QUALITY OPERATIONS MANAGER

Our client started with a mission to enable patients to enjoy simplicity, freedom, and healthier lives. Over the past two decades they have elevated their insulin management systems to a market leading position where they have improved the lives of hundreds of thousands of patients through the application of innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:

Reporting directly to the Senior Director of Quality Operations, the Quality Operations Manager provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of in-process, pre and post sterile release, and Environmental monitoring samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.

Responsibilities:

• Perform other duties as assigned
• Manages various QC/QA program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).
• Participates in internal and external quality audits
• Monitor, track publish and report QC/QA metrics (NCMR, CAPA, etc.) at the Operations meetings. As necessary analyze QC/QA metrics to identify trends and actions necessary to correct adverse trends
• Recruits, coaches, and develops organizational talent
• Manage Supervisors and Technicians to ensure
• Integral part of Plant Leadership team and serves as QC/QA representative in cross-functional, cross-departmental working teams
• Coordinates and facilities QC/QA activities to meet commitments on-time
• Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification, as required
• Leads compliance related teams working towards the goal of continuous improvement
• Ensure all QC/QA records and DHR documentation adhere to cGMP/GDP expectations
• Authors, review, and/or approves data, SOPs, COAs, DHRs and other documents as needed
• Assist in troubleshooting of test methods and/or equipment as required
• Ensure QC/QA personnel have appropriate training and competency
• May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence

Education and Experience:

Minimum Requirements:

• BS degree in scientific discipline; and/or equivalent combination of education and experience
• Minimum of 8 years’ experience of relevant experience in Quality Control / Quality Assurance
• Experience leading or supporting FDA and ISO 13485 inspections preferred
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Minimum 2 years’ experience in Operations Quality Management
• Must possess strong leadership and analytical skills with team-focused attitude
• Minimum 2 years’ managerial experience

Preferred Skills/Competencies:

• Excellent interpersonal, verbal, and written communication skills
• Advanced PC skill, word processing, spreadsheet, and database
• Ability to communicate and work effectively at multiple levels within the organization
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities