Head of Quality Strategy for Computerized Systems

Vor 2 Tagen

Frankfurt am Main, Hessen, Deutschland Merck Healthcare KGaA Vollzeit

Your role

The purpose of the Head of Quality Strategy for Computerized Systems (CS) role is to lead and establish the strategic direction necessary to ensure the integrity and compliance of quality management systems associated with R&D computerized systems and Artificial Intelligence (AI) technologies. This position is dedicated to driving continuous improvement initiatives within the QA framework, fostering a culture of quality across the organization, and ensuring that all systems adhere to regulatory standards while implementing risk-based validation strategies to maintain the highest quality standards.

This role directs and supports the global Quality Strategy team in executing QA activities related to Computerized Systems (CS) and Artificial Intelligence (AI), including managing audits and inspections for R&D CS and AI technologies. This person is accountable for defining and executing of GLP, GCP and GVP compliant, efficient validation & lifecycle management strategy for global R&D GxP systems & AI; identifying & driving continuous improvement of quality processes for computerized systems based on industry trends, metrics, audit findings, root-cause analyses and stakeholder feedback; continuously assess and refine strategic approaches to drive necessary changes in R&D Computerized Systems and AI, ensuring compliance with regulatory requirements and alignment with industry best practices.

The Head of Quality Strategy for Computerized Systems collaborates with executives and business partners to identify risk areas in Computerized Systems and AI, facilitate prompt communication, and drive effective issue resolution.

Who you are

  • Advanced degree (e.g., MSc or PhD) in Computerized Systems, Information Technology, or a related field. A degree in Life Sciences may be considered in combination with an equivalent related professional experience.
  • In-depth knowledge of pharmaceutical industry (all GxP areas, with focus on GCP, GVP and GLP) and drug development.
  • Minimum 10 years in Quality Assurance or computerized system validation in a GxP-regulated environment
  • At least 5 years managing global QA programs for computerized system compliance.
  • Deep knowledge of GLP, GCP, GVP regulations and global health-authority expectations for computerized systems
  • Proven ability to design and execute risk-based validation strategies for GxP systems.
  • Subject Matter Expert and proven working knowledge in, computerized systems validation
  • Excellent understanding of Artificial Intelligence regulatory requirements
  • In depth knowledge of applicable worldwide CS and AI industry relevant regulations and guidelines
  • Hands-on experience with eQMS tools, system life-cycle management frameworks, change control and data integrity principles.
  • Broad knowledge of continuous improvement, including Root Cause Analysis techniques; Lean Six Sigma knowledge/certification is a plus
  • Broad understanding of the drug development process and regulatory environment including specific areas of interest for Merck Healthcare e.g. biotherapeutics, oncology and emerging markets
  • Experience in leading a team as a people manager
  • Fluency in English (oral and written)

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