Sr. Manager, Quality Operations (Onsite)
Job Summary
Join Insulet as a Senior Manager, Quality Control and play a key leadership role in ensuring the quality and compliance of life-changing medical devices. In this highly visible position, you will lead QC operations, oversee laboratory testing, validation, environmental monitoring, and compliance programs, while developing and mentoring a talented team in a fast-paced, highly automated manufacturing environment. This is an excellent opportunity for an experienced Quality professional to drive continuous improvement, support regulatory inspections, collaborate across departments, and make a direct impact on patients worldwide as Insulet continues its rapid growth and global expansion.
About the Role
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 QC program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).
- Captures and coordinates QC activities to meet commitments on-time.
- Ensures QC personnel have appropriate training.
- Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification.
- Aids in troubleshooting of test methods and/or equipment as required.
- Authors, reviews, and/or approves data, SOPs, COAs, and DHRs.
- Maintains and publishes QC metrics.
- Ensures all QC records and DHR documentation adhere to cGMP/GDP expectations.
- Led 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.
- Recruits, coaches, and develops organizational talent.
- Performs 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.
Required 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; Highly proficient with industry standards sampling plans (ANSI z1.4 & z1.9); Experience working in a highly automated/high volume manufacturing environment; Support staff working in a 24/7 operation.
Physical Requirements
- Ability to lift up to 30 lbs.
- Frequent standing, walking, reaching above shoulders and below waist.
Additional Information
The position is working on-site at our Acton, MA location. NOTE: This position requires on-site working (requires on-site office/plant/lab work).
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. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. 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!