Job description
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
Job Title: Quality Operations Manager
Department: Quality
FLSA Status: Exempt
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.
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:
- 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
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
- 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
Preferred Skills/Competencies:
- 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
NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
Additional Information:
The US base salary range for this full-time position is $109,060.00 - $155,065.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
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