Manager, Quality Operations (Onsite - Acton, MA)

Job Summary

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.

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.

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:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $110,900.00 - $166,325.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.