Manager Process Excellence & Manufacturing Compliance (H/F)

Manager Process Excellence & Manufacturing Compliance (H/F)

Job Purpose :

To provide leadership, strategies and guidance to Process Unit to ensure Process Excellence.
Supports the Process Management Team in the coordinating and planning of all Process Unit activities (logistics, project work, services, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment and accountability).

 

Major Accountabilities :

  • Provide leadership to PU teams, and manage respective teams (Process Experts, MBR, MES) to ensure Process is understood, compliant and under control end-to-end
  • Ensure Manufacturing Documentation is up to date and compliant
  • Strive for continuously improving the way we manufacture; manage support activities in strong collaboration especially with MS&T, Process Science, and Process Development
  • Work closely with MS&T and Validation teams in technical process improvements, validations, and respective projects.
  • Act as Subject Matter Expert for PU Process, e.g. in audits
  • Lead & manage teams providing manufacturing related support services, such as Batch Record Review and Control, Deviation Investigation Management and CAPA Management
  • Manage support activities in strong collaboration with QA/QC, and MS&T
  • Ensures full alignment with Change Controls
  • Support Site Quality Plan and Site Quality Risk Assessment, and other relevant Compliance activities
  • Lead and/or participate in team member hiring
  • Facilitate all disciplinary actions for the team (including Performance Improvement Plans)
  • Foster and support a high performance team work environment
  • Lead and facilitate team meetings
  • Ensure Process is compliant: Quality/cGMP, HSE/OSHA, statutory, regulatory, financial, people, Data Integrity, and other Novartis requirements
  • Champion a strong Right-First-Time Mindset in the PU. Develop and strengthen the Process Oriented Organization (POO) culture by facilitating and promoting empowerment and accountability.
  • POO ambassador and role model in accordance with Novartis Values & Behaviors.
  • Drive continuous improvement in all LEAN, Innovation, Quality, Productivity (IQP) production and other processes/procedures to enable Process Unit performance to remain competitive and compliant.
  • Economic management of costs and investments (e.g. by efficient planning and utilization of technical and human resources).

Motivating, Leading & Influencing :

  • Encouraging cooperation between tactical and support teams
  • Gaining willing cooperation and energizing others
  • Communicating a compelling vision
  • Evaluating and appraising work of others for input to performance management
  • Making a spoken case for a plan or strategy
  • Making a case to superiors for support or resources
  • Challenging the status quo

Problem Solving and Deciding :

  • Making decisions after thorough evaluation
  • Deciding a course of action in collaboration with others
  • Deciding a course of action on own initiative
  • Diagnosing problems in a system or process
  • Finding ways to improve efficiency of an operation

Collecting, Analyzing & Evaluating Information :

  • Asking questions to establish information required
  • Listening to reports from superiors, colleagues or operators
  • Keeping abreast of current production metrics, performance and trends
  • Keeping abreast of new developments and knowledge
  • Analyzing written or numerical information and hypothesis testing
  • Assessing probability or likelihood of an event
  • Evaluating alternatives prior to choice

Planning and Monitoring :

  • Setting future priorities for utilizing resources
  • Anticipating problems or unexpected situations
  • Planning long term (strategy) objectives that are in alignment with the vision
  • Revising plans to account for changed circumstances
  • Organizing resources to meet an objective

 

Key Performance Indicators :

  • Process Unit KPI’s and budgets are achieved
  • Throughput time, process cycle times, Overall Asset Effectiveness (OAE) change-over optimization, inventory levels
  • Cost and budget
  • Out of Expectation (OOE), Out of Specification (OOS) and quality critical deviations, successful audits/inspections
  • Accident and incidence rates, successful audits/inspections

 

Ideal Background :

Education : Bachelor’s degree in Business/Engineering or Scientific discipline preferred, advanced degree desired

Language : Fluent in speaking and writing in English

Experience: Minimum of 7-10 years’ experience in production operations, ideally in a Biopharmaceutical, pharmaceutical or chemical manufacturing environment. Knowledge of a Process Oriented Organization and a self-directed culture is a plus.

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