Sr. Manager, Quality Operations (Onsite)

Job Summary

Join Insulet's growing team and lead critical Quality Control operations that help deliver innovative, life-changing medical devices to patients around the world. As a Senior Manager, Quality Control, you'll oversee laboratory testing, validation, lot release, compliance, and continuous improvement initiatives while leading and developing a high-performing team in a fast-paced, highly automated manufacturing environment. This is an exciting opportunity for an experienced quality leader to drive operational excellence, collaborate across global teams, support FDA and ISO compliance efforts, and make a meaningful impact as Insulet continues its rapid growth and expansion.

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

Reporting directly to the Director of Quality Operations, the Sr. Manager, Quality Control 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 management responsibilities.

Responsibilities

• Manages various processes within the department (shift schedules, workflow, training, sample management, data review and reporting) and serves as subject matter expert (SME).
• Coordinates and facilities QC activities to meet commitments on-time.
• Ensure QC personnel have appropriate training.
• Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification
• Assist in troubleshooting of test methods and/or equipment as required
• Responsibility as global lead for Lot testing/qualification activities.
• Collaborate with other department leaders as appropriate.
• Authors, review, and/or approves data, SOPs, COAs, and DHRs
• Monitor, track and publish department metrics.
• Ensure all QC records and DHR documentation adhere to cGMP/GDP expectations
• Responsible for final lot release
• 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
• Serves as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all QC needs
• Participates in internal and external quality audits
• Recruit, coach, and develop organizational talent
• Perform other duties as assigned

Education and Experience

• BS degree in scientific discipline; and/or equivalent combination of education and experience
• Minimum of 10+ years’ experience of relevant experience in Quality Control / Quality Assurance
• Minimum 2+ years’ managerial experience in a manufacturing environment
• Must possess strong leadership, analytical and communication skills with team-focused attitude
• Experience leading or supporting FDA and ISO 13485 inspections preferred

Preferred Required Skills Competencies

• Highly effective leadership skills.
• Excellent interpersonal, verbal and written communication skills
• Problem Solver
• 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 as well as across global sites.
• Advanced PC skills, word processing, spreadsheet, and database
• Highly proficient with industry standards sampling plans (ANSI z1.4 & z1.9)
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Experience working in a highly automated/high volum