Director, Program Management & Operations (Hybrid)

Insulet Corporation•San Diego, CA

1d•Hybrid

About The Position

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.

Requirements

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
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.
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.).
Strong communication, leadership, and stakeholder management skills.

Nice To Haves

Six Sigma certification and experience desired.
PMP or similar certification preferred.

Responsibilities

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.
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.
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
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.