Main Purpose and Objectives:

  • Provide quality leadership, direction, and governance for the assigned area of responsibility.

  • Manage quality-related matters within the specific Quality System or Quality Program domain.

  • Approve relevant quality-related documentation, ensuring compliance with internal policies and GMP requirements.

  • Establish, maintain, and manage a control system for the assigned Quality System or Program, including training of associated personnel.

  • Offer expert consulting, training, and feedback to site and corporate teams, driving compliance with computer system quality standards.

Key Responsibilities:

Computer System Quality & Compliance

  • Maintain full compliance with GMP and computer system quality (CSQ) requirements for all systems under the area of responsibility.

  • Provide oversight, guidance, and approval for computer-related validation documentation.

    • Includes documents resulting from the Computer System Validation Process (CSVP) and other quality-related processes across laboratories, IT, and process automation systems.

  • Lead training initiatives to ensure new and existing personnel are equipped with knowledge of computer system quality standards.

  • Support the development and implementation of standardized local procedures for computer systems.

    • Assist with the consistent interpretation and application of corporate quality policies across all areas including IT, Process Automation, and Lab Automation.

    • Collaborate with global and regional forums to identify and roll out needed processes and participate in cross-functional quality initiatives.

  • Escalate critical quality issues to appropriate management levels for resolution.

  • Participate in cross-departmental meetings and forums to promote consistency in quality practices and share lessons learned.

  • Stay informed about external trends and changes in regulations; communicate relevant updates to the organization.

  • Lead system maintenance activities and ensure compliance with validation lifecycle requirements.

  • Oversee compliance with procedures related to periodic review, change control, deviation management, system backup/archiving, and data security.

Educational Requirements:

  • A Bachelor’s, Master’s, or Ph.D. in Chemistry, Engineering, or a related discipline is required.

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