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
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

Requirements

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.

Benefits

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

program managementproject managementprocess improvementquality systemsbudget planningKPI monitoringprogram trackingreportingstrategic planningresource optimization

Soft Skills

leadershipcommunicationstakeholder managementcollaborationstrategic thinkingproblem-solvingorganizational skillsadaptabilitytrust buildingcross-functional teamwork

Certifications

Six SigmaPMP