Job Title: Director, Program Management & Operations

Department: Regulatory Affairs, Quality Assurance & Compliance

Manager/Supervisor: SVP, Regulatory Affairs, Quality Assurance & Compliance

FLSA Status: Exempt

Position Overview

The Director, Program Management & Operations, Regulatory Affairs & Quality, is a strategic leader responsible for driving operational excellence and accountability across all Quality and Regulatory Affairs initiatives. This role reports to the functional SVP and partners with senior leadership and cross-functional teams to deliver measurable impact, champion process improvements, and ensure rigorous execution of enterprise-wide programs. This role will support senior leadership meeting coordination and execution as well as champion process improvements within the function and across the broader Insulet enterprise, ensuring initiatives are executed with rigor, transparency, and measurable impact. Reporting directly to the executive leader, this position partners with cross-functional teams to deliver operational excellence.

Responsibilities

Strategic Leadership

• Lead and manage a portfolio of strategic regulatory and quality programs, ensuring alignment with enterprise priorities and compliance requirements.
• Partner with all functional area VPs and Management staff and other enterprise functions, in establishing overall program goals, scope, resources, and the plans for
• seamless execution of initiatives.
• Help define clear strategic priorities, and project milestones across a matrixed, cross-functional team of key stakeholders.
• Act as a trusted liaison between executive leadership and program teams, translating strategic goals into actionable plans.

Operational Excellence and Continuous Improvement

• Establish and maintain operating rhythms for leadership meetings as well as strategic priorities (e.g., steering reviews, milestone check-ins, risk assessments) to ensure transparency and accountability.
• Drive adoption of standardized tools and frameworks for program tracking and reporting.
• Champion a culture of quality and continuous improvement and operational excellence.
• Develop and maintain integrated program plans, timelines, and deliverables across functions.
• Identify and implement process enhancements to improve efficiency, compliance, and quality outcomes.
• Lead cross-functional initiatives to drive enterprise-wide process improvements.

Financial & Resource Management

• Support development and accountability to budget and other financial planning deliverables across the function.
• Optimize resource utilization and monitor KPIs to assess program health and impact

Communications & Stakeholders Engagement

• Prepare executive-level dashboards and reports to communicate progress and escalate risks.
• Serve as primary communications conduit to external partners and internal cross-functional project teams executing project tasks and details.
• Coordinate agenda and meeting design to ensure smooth execution of functional town halls and senior and extended leadership offsites.
• Perform other duties as required.

Required Leadership/Interpersonal Skills & Behaviors

• Decision Making - has a systematic and methodical approach to making decisions, obtains relevant information, thinks beyond the immediate decision point, challenges assumptions and considers business implications of potential solutions.
• Communication Skills - Conveys information effectively, actively listens, resolves conflict constructively.
• People Leadership - Ability to lead and influence effectively and lead in a matrixed organization.
• Strategic thinking with operational execution excellence.
• Strong analytical, problem-solving, and planning skills.
• Ability to work independently and collaboratively across all levels of the organization.
• Positive Change Agent - curious, adaptable, and energizing leader with a global mindset.
• Customer and Market orientation - a commitment to both understanding and serving customers (internal/ external), while also staying attuned to broader market dynamics.
• Culture Ambassadorship - champions and models the organization's values, fostering a culture of quality, inclusion, and continuous improvement across all teams

Required Skills and Competencies

• Experience working with a global organization handling large product volumes of regulated products, including hardware and software required.
• Experience with enterprise governance frameworks and digital program management tools.

Education and Experience

• Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 10+ years of experience in program/project management within regulated industries (medical devices, pharma, biotech).
• Deep understanding of quality systems and industry standards (ISO 13485, FDA QSR, EU MDR, etc.).
• Six Sigma certification and experience desired.
• Proven track record of leading cross-functional programs and driving enterprise-wide process improvements.
• Strong communication, leadership, and stakeholder management skills.
• PMP or similar certification preferred.

Additional Information

• The position is hybrid. The preferred location is Acton or San Diego.
• Travel is estimated at 20% but will flex depending on business need.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $169, 700.00 - $254, 525.00 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.

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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