Sr Director, Quality & Regulatory Strategy and Operations (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

1d•Hybrid

About The Position

The Senior Director, Quality & Regulatory Strategy & Operations is a trusted strategic advisor and execution leader to the SVP - Chief Quality, Regulatory, and Compliance Officer (CQRCO). This role partners closely with the Quality, Regulatory, and Compliance Leadership Team, and cross‑functional leaders to define, operationalize, and deliver the enterprise Quality and Regulatory strategy. Operating at the intersection of strategy, governance, and execution, this leader serves as the Chief of Staff to the CQRCO while also owning program and portfolio management for critical Quality, Regulatory, and Compliance initiatives. The role ensures strategic priorities are clearly defined, resourced, sequenced, and executed with rigor and transparency across the enterprise. This is a highly visible, enterprise-facing role requiring strong strategic thinking, executive presence, systems leadership, and the ability to drive complex, multi-year transformation initiatives in a highly regulated medical device / healthcare environment. Key Objectives: Serve as a strategic thought partner and Chief of Staff to the SVP, CQRCO; Translate Quality, Regulatory, and Compliance vision into clear enterprise strategy and execution roadmaps; Establish governance, operating cadence, and program management discipline across Quality & Regulatory initiatives; Drive cross-functional alignment and execution of high‑priority, enterprise‑critical programs; Enable executive decision-making through insightful analysis, scenario planning, and performance tracking; Support organizational readiness for regulatory inspections, audits, and major external milestones; Strengthen integration and coordination across Quality, Regulatory, Compliance, R&D, Manufacturing, Supply Chain, and Commercial teams.

Requirements

Bachelor’s degree required
12+ years of progressive experience in Quality, Regulatory Affairs, Compliance, Strategy, PMO, or Management Consulting
Demonstrated experience supporting or partnering with C‑suite or senior executive leaders in a Chief of Staff, strategy, or enterprise PMO capacity
Deep understanding of FDA regulations, global regulatory frameworks, quality systems, and inspection readiness
Proven track record leading complex, cross‑functional enterprise programs with material business impact
Strong analytical capabilities, with the ability to synthesize complex data into clear executive insights
Exceptional communication skills (written, verbal, executive presence)
Articulates a clear, compelling vision that integrates Quality, Regulatory, and Compliance into enterprise value creation
Applies data, insight, and judgment to shape priorities and inform decisions
Balances ambition with practicality, ensuring strategies are executable and sustainable
Drives disciplined execution with clear accountability, milestones, and outcomes
Navigates ambiguity with confidence and adaptability
Anticipates risks and enables proactive mitigation
Builds trust rapidly across diverse stakeholders
Leads complex initiatives without formal authority
Fosters collaboration, alignment, and shared ownership
Demonstrates sound judgment, transparency, and ethical leadership
Operates with a strong enterprise mindset, balancing risk, compliance, and growth

Nice To Haves

Advanced degree (MBA, MS, PhD, JD) strongly preferred

Responsibilities

Partner with the CQRCO and senior leaders to define and articulate the long-term Quality, Regulatory, and Compliance strategy, aligned to corporate objectives and growth plans
Lead development of the annual Quality & Regulatory strategic plan, including prioritization, sequencing, and resourcing of initiatives
Conduct ongoing enterprise landscape assessments, including regulatory trends, enforcement themes, industry benchmarks, and emerging risks
Lead scenario planning and strategic analyses to inform executive decisions related to compliance posture, risk mitigation, and growth-enabling strategies
Act as the CQRCO’s primary strategic and operational integrator, ensuring clarity, focus, and follow‑through across priorities
Prepare executive briefings, strategic updates, and materials for ELT, Board, and external stakeholder engagements
Drive leadership meeting agendas, decision forums, operating cadence, and follow-up actions to ensure accountability
Facilitate communication and alignment across the Quality, Regulatory, and Compliance leadership team and the broader enterprise
Establish and oversee a portfolio management framework for Quality, Regulatory, and Compliance initiatives
Lead execution of enterprise‑critical programs, including quality system transformations, regulatory readiness, remediation efforts, inspection preparedness, and capability buildouts
Implement consistent program management standards, milestones, risk tracking, and dependency management
Proactively identify delivery risks, constraints, and gaps; drive mitigation plans and escalation as needed
Serve as a connector across functions, aligning Quality & Regulatory priorities with R&D, Operations, Manufacturing, Supply Chain, IT, and Commercial partners
Lead and influence without direct authority, mobilizing cross‑functional teams to drive outcomes
Support change management and adoption of new processes, systems, and ways of working
Ensure learnings from audits, inspections, and external feedback are translated into sustainable enterprise improvements
Define and monitor enterprise-level KPIs related to Quality, Regulatory, and Compliance effectiveness
Develop executive dashboards and performance reporting to support transparency and decision-making
Support preparation for Board-level reviews, external audits, and regulatory engagements