Description:
- Own the vision and strategy for the R&D Stability function.
- Optimize the distribution of stability related activities and coordinate across global internal and external sites.
- Establish and maintain external stability testing business relationships.
- Develop in-house Registration Stability testing capabilities according to business needs.
- Provide technical, team, and people leadership to Stability Subject Matter Experts.
Essential Duties and Responsibilities:
- Global R&D Stability Vision and Strategy – Refine the vision, translate it into a concrete strategic plan. Inspire the team to action consistent with that vision. Set high standards and goals and remove barriers to excellence.
- Lead talent selection, development, retention efforts, establishing clear criteria for measuring team and individual success. Provide feedback, recognition, and opportunities for cross-training. Coach and motivate team members, ensuring their developing expertise aligns both with their career interests and with business needs.
- Understand strategic imperatives to project success (e.g., timing of market entry, innovative technology, and costs), developing plans that incorporate global and regional business practices and customer requirements.
- Understand and effectively communicate how projects fit into the organization’s strategies. Ensure that team objectives align with key business strategic programs.
- Develop project schedules and budgets, employing project management tools to manage them.
- Review and implement best practices and team processes to enhance operational efficiency, resolve issues, improve project timelines, and make timely, risk-based decisions. Solicit regular input from customers and take appropriate action.
- Be accountable for successfully meeting agreed upon milestones.
- Collaborate across functions such as Quality, Regulatory Affairs, Sterility Assurance, Extractables and Leachables, Analytical Chemistry, Product Design Owning teams, Project Management and Manufacturing.
- Provide leadership by guiding in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
- Generate innovative and expeditious solutions to complex problems by leveraging multiple disciplines and technical principles. Develop innovative processes and methods through fusion of expertise.
- Cultivate a professional network both internal and external to the business.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements to ensure compliance in all research, data collection and reporting activities.