Senior Director Stability & Technical Operations
Round Lake, IL
Req ID 51211BR
Business Title
Senior Director, Stability & Technical Operations
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Partner with Sr. Management to develop long-range business strategies at the divisional level.
Ensure organizational processes and systems support for attracting, developing and retaining superior talent. Remove organizational barriers to outstanding performance.
Identify and develop relevant core technical competencies that meet current and future needs of the division. Ensure the development of human and technical resources needed to meet long-term objectives of the division.
Create an environment that nurtures innovation (e.g. trade secrets, patents, and publications) that provide business advantages to the division.
Create a collaborative climate across business units to achieve divisional goals.
Responsible for ensuring business objectives are met. Provide leadership through senior team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
Create and communicate a global vision of the organization's contribution to the business goals, insuring industry leadership. Inspire team to action consistent with vision. Establish high standards and stretch goals for organization. Remove barriers to outstanding performance. Hold team accountable for successful completion of projects/tasks.
Establish long-range business plans which anticipate global trends, technical, economic and socio-political conditions and provide support for project/business strategy.
Select, develop and retain multi-disciplined team that includes more senior management and technical contributors. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Successfully coach, mentor and motivate others for outstanding performance.
Ensure development of state-of-the-art expertise in industry and function specialties; deploy effectively.
Define and communicate strategic imperatives to project success (i.e.: timing of market entry, innovative technology and costs). Develop strategic plans that incorporate regional and global business practices and customer needs.
Develop effective program milestones, schedules and budgets, including capital. Employ state-of-the-art program management tools to manage to those program schedules and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency. Identify and resolve issues that may jeopardize program schedules or improve program time. Seek regular input and feedback from customers and take appropriate action.
Develop budgets for each cost center within scope of responsibility which ensure the best utilization financial resources.
Proactively prioritize and balance utilization of resources allocated to program; identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/program; present internal vs. external analysis.
Understand and effectively communicate to team members about the market niche, competitive forces influencing the project, and how the project fits into the function's strategic focus/plan. Ensure that team objectives align with key Corporate strategic programs. Accountable for successfully meeting agreed upon milestones for key Corporate projects.
Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization.
Build a professional network both internally within the business unit, across units and outside of Baxter.
Direct team members to effectively transfer technology from design development to implementation.
Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
Provides leadership to maintain and enhance our core competency in stability, and to ensure technical soundness of study design and interpretation of data, as well as compliance with regulatory requirements and industry standards.
Provides leadership in evaluation of stability data and resulting recommendation of solution product expiration dating for developmental and commercial solution products.
Provides leadership in setting and meeting standards for preparation of stability sections for regulatory submissions, and responses to regulatory authority communications.
Provides leadership to maintain and enhance computerized systems used within Medical Products R&D, ensuring compliance to validation requirements.
Provides leadership to maintain and enhance stability storage chambers to ensure compliance with regulatory requirements and industry standards.
Provides leadership to maintain and enhance instrument qualification and calibration processes to ensure compliance with regulatory requirements and industry standards.
Provides leadership to maintain and enhance Glass Laundry and Stock Room operations to ensure the needs of R&D labs are met.
Provides leadership with respect to continuous improvement, benchmarking and reengineering in areas of responsibility.
Utilizes knowledge of existing solution product lines and product stability to support Global Quality, Manufacturing, and Product Development organizations in their efforts to improve existing products, resolve issues, and support development of new products.
Supervises managers and supervisors, and ensures training, development and succession planning for all employees within the organization.
Manages budget and deployment of resources within the organization to meet budget and prioritization commitments.
Job Requirements
Must possess strong knowledge of scientific disciplines and solid knowledge of related disciplines.
Knowledge of quality and general business systems.
Must possess strong ability to negotiate for resources and influence others internally and externally.
Must be able to set strategic direction for the organization and broadly communicate the vision.
Ability to operate on a much broader scope.
BS in related scientific discipline, with 16 + years, MS with 13+, or PhD with 10+ years relevant experience.
Minimum 5 years technical and strategic management experience including cross-functional teams, resource and budget management and strategic development experience
Excellent interpersonal, written and oral communication skills.
Thorough knowledge of European MOH and FDA guidelines, industry practices, New Drug Application processes, GMPs and GLPs, stability computer systems, instrument qualification and calibration processes as well as commitment to the Baxter Quality Process.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
