Manager, Quality Operations (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

1d•$110,900 - $166,325•Onsite

About The Position

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.

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
Minimum 2 years’ managerial experience
Minimum 2 years’ experience in Operations Quality Management
Must possess strong leadership and analytical skills with team-focused attitude
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

Nice To Haves

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

Responsibilities

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