Reporting directly to the Director of Quality Operations, the Manager, Quality Operations provides an oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of incoming, in-process, and post sterile release. This role also plays a critical role in managing control of product flow from through the supply chain, especially as it relates to holds and non-conforming products.  This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.

Responsibilities:

People Manager - Responsible for the day-to-day management of a group of employees.

Performance management: Monitor employee performance, provide feedback, and address performance issues

Goal setting: Set goals for the team and ensure employees understand how their work contributes to company objectives

Team development: Recruit, train, and develop new employees who fit the company's culture

Employee engagement: Create a supportive and inclusive work environment
 

Manages various QC/QA program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).  Primary focus is on warehouse and distribution along with Incoming and QC activities at 50 Nagog site.

Ensures post-sterile product is not released for distribution until all Device Master Record requirements have been met.

Ensures appropriate product control throughout the supply chain for USAM product and collaborates with other quality leaders globally on the same.

Coordinates and facilities QC/QA activities to meet commitments on-time

Ensure QC/QA personnel have appropriate training and competency

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 50 Nagog leadership and serves as QC/QA representative in cross-functional, cross-departmental working teams

Participates in internal and external quality audits

Perform other duties as assigned

Minimum Requirements:

BS/BA degree required.

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

Preferred Skills and Competencies:   

Excellent interpersonal, verbal, and written communication skills

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

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

Travel Requirements:

As required as dictated by the needs of the business (up to 15%)

Physical Requirements:

The Quality manager's physical requirements involve the ability to walk, stand, and occasionally bend or reach within an environmentally controlled production facility which includes frequently entering the cleanroom. Often spend long periods sitting at a computer while also being able to move around to inspect products or processes, which may include occasional lifting.

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 $108,075.00 - $162,112.50. 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.

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!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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