Posted 1 year ago

Key responsibilities:

  • Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
  • Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective
  • Take a lead role in the transversal QMS Procedural Document & Training Governance ensuring harmonization, efficiencies and simplification where appropriate
  • In collaboration with Business stakeholders (incl. senior leaders / process owners), develop and implement streamlined processes / procedural documents compliant with regulatory, industry, and internal quality standards
  • Drive and ensure continuous alignment with QMS ProcDoc / Training principles and ways of working across the different functional areas through engaging with key stakeholders, functional teams, and Process Owners
  • Provide oversight for the development and maintenance of the Quality Management System and related electronic systems, processes and procedures that ensure compliance with internal and external standards
  • Coach and lead Business stakeholders and Quality representatives by providing leadership, expert advice, support and management for translating QMS ProcDoc & Training strategy into operations
  • Foster a change management culture to facilitate adoption and usage of new ways of working.  Act as a “Change Agent” to drive the culture of process improvement throughout the organization
  • Management and reporting of quality key performance indicators related Procedural Document and Training Management

Your profile:

  • At least 15 years ‘experience in Pharma Industry, with at least 10 years in QA and/or QMS roles
  • Master’s degree in Science
  • Expertise in Quality Management Systems in a regulated, agile, mid-size biopharmaceutical company; in transversal GXP (preferably GCP) Quality Management System and related operations
  • Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
  • Having demonstrated the ability to drive significant changes in a Quality Management organization
  • Experience in strategic partnering with senior leaders and quality representatives
  • A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
  • A good and thorough understanding of current regulatory requirements.
  • Ability to interpret current regulations and requirements is essential
  • Excellent verbal and written communication and interpersonal skills
  • Excellent presentation skills and ability to present content in front of senior management
  • Rigor, flexibility, adaptability, and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Technical skills in view of system / application / software related activities

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