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Forming part of a group of technical experts (SMEs) responsible for the continuity, quality, compliance & profitability of Nutrition Solutions on-market products. Support the execution of product changes in compliance with international regulations and quality standards; working with cross-functional teams and/or SMEs to ensure problem-solving, decision-making and change execution occur within project timelines.
Job Responsibility:
Lead a team of scientists responsible for the management and execution of lifecycle design supporting activities for the Clinical Nutrition Solutions On-Market products
Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc
Ensure that personal and team objectives align with key Segment initiatives
Manage routine and complex supplier notice of changes (SNCs), change control records, product code obsolescence and product end of life (EOL) activities in addition to general technical administrative tasks
Organize, plan and execute product changes in compliance with international regulations and quality standards
coordinate and set up cross-functional team meetings to ensure change execution, problem-solving and decision making
Independently plan, execute, and manage project(s) that span multiple disciplines with team, cross functions and regions
Employ project management tools to manage project schedules and budgets against milestones
review and apply best-demonstrated practices, team processes, and improve operational efficiency
Identify and resolve issues that may jeopardize project schedules and/or improve project timelines
Build and maintain a metrics system to track the progress of operational activities and critical KPIs
Summarize and report out results in both oral and written formats to manager and Senior Leadership team (SLT), as required
Manage market enhancements and operational improvements
Participate in development and improvement activities associated with the design, manufacturing and control of products
Prepare technical protocols and reports
Adhere to the Quality Systems, understand and apply applicable corporate, divisional and departmental procedures as required
Requirements:
Bachelor’s degree in a scientific discipline (Chemistry/Biology/Pharmaceutics/Chemical Engineering) with 10+ years experience
Masters degree with 5+ years experience or PhD with 1+ year experience
Relevant experience is preferably in the pharmaceutical industry with a broad background in solutions/drug development/lifecycle management
Good knowledge of: Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
Design Control documentation and process
Statistical Analysis and/or Lean/Six Sigma tools
International/regional/national regulations and standards
Self-motivated, resourceful, and flexible
A self-starter is imperative
Strong interpersonal communication skills and ability to communicate effectively with internal and external customers
Skilled at presentations within the business/technical community
Technical writing proficiency to author internal reports and scientific papers
Strong human relation skills for group leadership, individual leadership, and project management
Ability to lead, manage and facilitate cross-function/division teams
Ability to break down technical processes and effectively delegate to junior team members
Strong quantitative and qualitative assessment skills and critical thinking skills in support of analyzing and solving complex problems through innovative thought and experience
Demonstrated ability to lead technical projects through successful outcomes
Ability to design and implement projects/studies outside area of expertise
Demonstrates flexibility and ability to shift gears between projects comfortably
Fluent in English
Nice to have:
Familiarity with the utilization of analytical instrumentation in test methods and/or process engineering is desirable