Sr Manager, Document Control

Quality Document Services Manager

Provides strategic management for Quality Document Services at Insulet. Partners with stakeholders to ensure an effective and efficient document change management process that meets the needs of the business. Responsible for establishing relevant Key Performance Indicators that support quality and business objectives. Drives continuous improvement and develops programs to increase the process efficiency and scalability for business growth. Ensures applicable QMS regulatory requirements and standards are incorporated into the QMS Process for Document and Records Controls and is responsible for ongoing compliance.

Responsibilities

• Serves as QMS Process Group Owner for Document, Record & Change Controls.
• Leads the development and roll-out of document control tools.
• Lead implementation of Change Order Training & Certification Program.
• Provides oversight of project contractors and vendor resources.
• Supports business initiatives, identify trends and recommends and implements best practices to ensure scalability and growth.
• Maintains a watchful and alert attitude toward the Document Control process, including developing routine reports and metrics to gauge success. Provide inputs to Monthly Data Analysis and Management Review, as required.
• Leads or participates as the QMS representative in Document & Record Control improvement projects.
• Works cross-functionally to improve the content in change orders for approval.
• Manages and develops document control staff at various levels.
• Creates a strong, high performing team with a collaborative culture and customer centric mindset.
• Performs other duties, as required.

Education and Experience

Minimum Requirements :

Preferred Skills and Competencies :

Physical Requirements (if applicable) :

Additional Information :

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.