The Director RQS Operations, also known as the Director, RQS Business Systems Strategy develops a holistic and enterprise perspective of business systems that impact Regulatory Affairs, R&D Quality Assurance, and Safety. Networks with external peers to better understand best practices and share industry trends. Demonstrates knowledge of state-of-the-art business solutions and innovative approaches to solving business issues. Connects with appropriate subject matter experts internally and externally to create industry leading solutions. Partners with IT and Business leads to oversee the capital project governance across RQS in alignment with the RQS business and IT strategy. Responsible for one or more business consulting solution offerings in support of RQS cross-functional IT projects and initiatives. Manages a capital project budget of ~ $15MM, and owns and leads the capital project governance processes to support delivery of the portfolio.
Creates an impactful future vision, develops innovative strategies for achieving the vision, and drives the process of turning the future vision into reality.
· Leads capital project governance processes for RQS capital project portfolio initiatives to ensure alignment with business and IT strategy.
· Collaborates with IT on proactive look at technology required to empower RQS becoming a World Class organization.
· Co-leads the RQS IT Steering Committee helping to drive consensus on the RQS IT Strategy and long range plan. Directly interfaces with RQS senior leadership providing strategic guidance and a holistic business system perspective to maximize opportunities stemming from compliance requirements, technological advancements, and new business objectives.
· Partners with IT organization to drive Long Range Planning (LRP) and Capital Planning efforts in support of the Regulatory Affairs, R&D Quality Assurance, and Safety functions. Manages ongoing RQS IT Portfolio Budget forecasting and prioritization of initiatives.
· Builds impactful relationships and trust with supporting IT organizations, Business System Owners, and critical project sponsors by leveraging comprehensive understanding of business usage of systems across business partners including R&D and Operations to enable improved usage of existing solutions.
· Possesses a working knowledge of business processes and regulations across the complete drug product life-cycle, and knowledge of business processes and regulations in one or more Regulatory Affairs, R&D Quality Assurance, and Safety sub-functions. Acts with demonstrated ability to analyze complex IT related business problems, facilitate the design of innovative solutions, craft compelling business cases, sell new ideas to management and plan/oversee effective implementation of major technology-related initiatives.
· Effectively frames complex issues for decision-makers and peers. Prepares and delivers effective management presentations to AbbVie Leadership. Draws upon personal knowledge of business processes, global regulations, organizational improvement methods, and communication mechanisms to propose and design innovative organizational improvements.
· Exercises superior interpersonal, coaching, and mentoring skills to create and sustain an environment that attracts, develops, and retains RQS Operations staff while enhancing organizational communications and structure, business relationships, business consulting, and project management.
Travel
Yes, 15 % of the Time
Basic
· Bachelor’s degree
· 12 years’ related experience
· Proven 7 years in a leadership role with strong management skills
· 2 years managing people
· Strong communication skills, both orally and written
· Strong business acumen and negotiating skills
· Experience working in a complex and matrix environment
· Demonstrated ability to lead multi-divisional and multi-functional teams with global aspects
Preferred
· Advanced degree preferred
· Project Management Institute (PMI) Project Management Professional (PMP) certification preferred
· 6 years in regulatory affairs, pharmacovigilance, or R&D quality assurance
· 6 years in pharmaceutical, healthcare or regulated industry
· Proficiency in project planning and management experience including successful implementation of business and technology initiatives
· Strong knowledge of pharmaceutical regulations, e.g., FDA and EMA and their impact to organization processes and technology tools
· Experience serving and managing business management consultants
· Experience analyzing complex business problems and facilitating the design of innovative solutions
· Ability to craft compelling business cases and sell new ideas
· Experience in managing functional budgets and developing budget forecasts
· Experience leading and managing functional business area
· Experience developing sub-function level business strategies
· Knowledge of Continuous Improvement/Lean Six Sigma concepts
· Note: Higher education may compensate for years of experience
Key Leadership Competencies
· Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
· Learns fast, grasps the 'essence' and can change the course quickly where indicated
· Raises the bar and is never satisfied with the status quo
· Creates a learning environment, open to suggestions and experimentation for improvement
· Embraces the ideas of others, nurtures and manages innovation to reality
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