The Sr. Manager, Quality Strategy and Data Analytics will be accountable supporting the creation of the site and/or global Quality Strategy and the successful delivery of assigned programs and projects, and the overall delivery of the Quality Strategy. The role will serve as a key contributor in end-to-end project/program objectives and outcomes, especially driving efficiency and agility with a strong focus on automation and utilization of digital tools (e.g., AI). This role will drive and support projects across the site and/or global quality functions and will identify and communicate opportunities to their respective leadership teams. Additionally, this role will develop and implement enhanced data analytics tools and dashboard to enable proactive identification of adverse trends impacting product quality and key site indices (e.g., Quality Index, Perfect Index).
Requirements
- 10+ years experience across Quality Management, Operational Excellence / Continuous Improvement, Data Analytics, Manufacturing and / or Technical Support within the Medical Device, Human Tissue or Pharmaceutical industry.
- 6+ years project management experience and/or operational excellence- methodologies within global companies, working on cross-functional strategic initiatives.
- Broad knowledge of quality systems and quality operations best practices is required
- Demonstrated ability to assess and identify OpEx / Continuous Improvement opportunities.
- Extensive project planning and management experience including successful implementation of business and technology initiatives.
- Prior experience identifying and implementing automated / AI-drive solutions is preferred
Responsibilities
- Develop Quality Strategy for relevant scope, in partnership with key stakeholders
- Develop and manage assigned key project artifacts such as project charters, status reports, work plans, stakeholder engagement plans and decision-making model. Establish project deliverables such as process flow maps, business tools and research analysis
- Recommend and implement departmental improvement initiatives to enhance effectiveness by utilizing methodologies such as Six Sigma, Lean Six Sigma, and Kaizen, while also developing and maintaining data analytics tools and dashboards to proactively identify adverse trends
- Manage the entire lifecycle of projects including driving team accountabilities, addressing project issues/risks, driving effective decision making and delivering status updates/recommendations to function head or senior management
- Work with functional leaders to propose new projects to continue to enhance productivity, compliance and efficiencies within their functions. Proactively identify and implement opportunities to optimize project team effectiveness and outcomes
- Proactively raise awareness of adverse trends or risks impacting product quality and key site indices (e.g., Quality Index, Perfect Index), and prepare actionable mitigation proposals to the Quality Leadership Team and the Site Leadership Team
Other
- Bachelor’s degree at a minimum, advanced degree preferred or equivalent experience
- Project Management Institute (PMI) Project Management Professional (PMP) certification preferred. Lean Six Sigma certification(s) preferred.
- Proven Success in a leadership role with strong leadership/management skills.
- Strong communication skills, both orally and written, and ability to make agile and decisive decisions.
- Experience working a global, complex and matrix environment
