Primary responsibility is to develop, align and communicate an integrated strategy that will continue to transform the Quality function. Reporting to the Senior Director, IT Quality, this role will support the senior management team by aligning future capabilities and services with the organizations' strategic direction. The role will also drive align across the Operations organization to ensure a cohesive and comprehensive approach to all future Quality solution development.
Responsible to develop and align the department's long-range roadmap and plans, key focus areas and create and continuously evolve an integrated strategy for Quality systems.
Develops communications to illustrate the department's strategic and long-range plans, key focus areas, measurement and progress against goals and department ROI.
Collaborate with business partners to influence business strategies and ensure short and long-term IT strategic alignment to business roadmaps.
Drives cross functional alignment of Quality initiatives across Operations to ensure strategic integration and maximum delivery of value.
Collaborates with department leaders to facilitate development of Business Cases for IT Quality projects and initiatives ensuring alignment to the long-range strategy.
Responsible for value management, works with leadership to ensure value creation occurs within the scope for of the portfolio by ensuring overall alignment to the Quality strategy. Recommends program/project changes to maximize efforts and ensure the department is supporting key business initiatives and driving maximum business value.
Collaborate across all IT organizations to identify innovative business opportunities that support the department's strategic priorities and executable plans.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Bachelors Degree required. Degree in Business, Computer Science or related discipline preferred. MBA or Master's Degree - Desirable or equivalent years of experience.
12 - 15 years experience include but not limited to:
Prior experience in a quality regulated industry with a strong understanding of pharmaceutical product development, manufacturing and quality business practices within pharmaceuticals, biologics, devices and combination products
Knowledge of global regulations including FDA and EMEA requirements and experienced in providing IT solutions aligned with these regulations
Must be comfortable with ambiguity; demonstrate strong writing, problem solving and creative thinking skills, and ability to work effectively with conceptual structures, outlines and models.
Experience working in a global matrix organization