Senior Manager, Computerized Systems Validation and Assurance

1 day ago


Florham Park New Jersey, United States Shionogi Inc. Full time
About the Role

We are seeking a highly skilled and experienced Senior Manager to lead our Computerized Systems Validation and Quality Assurance team at Shionogi Inc.

Key Responsibilities
  • Manage and oversee system validation and infrastructure qualification to ensure compliance with regulatory requirements.
  • Review and assess Change Control requests to ensure they do not impact validation.
  • Perform gap analysis of validation documentation, systems, and practices to identify areas for improvement.
  • Lead risk assessments and drive risk mitigation strategies to minimize potential issues in computerized system validation.
  • Ensure all validation activities adhere to relevant regulations, industry standards, and company policies.
  • Support continuous improvement initiatives to optimize validation processes and implement best practices.
  • Develop and maintain standard operating procedures (SOPs) and policies related to computerized system validation.
  • Collaborate with IT and system owners to implement new computerized systems, system upgrades, or system modifications.
  • Build and maintain strong relationships with internal stakeholders and external vendors to facilitate successful system implementations.
  • Participate in supplier site Validation Assessments/Audits and work with suppliers to troubleshoot and improve systems and processes.
  • Prepare for regulatory inspections by ensuring all documentation and processes are in compliance with regulatory requirements.
Requirements
  • Bachelor's Degree in a Scientific or Engineering discipline.
  • Minimum of five (5) years of computerized system experience with IT compliance/validation/qualification activities.
  • Minimum of five (5) years of experience in an FDA-regulated, GxP-related environment.
  • Demonstrated results-oriented, quick learner, team player with excellent communication skills.
  • Knowledge of industry standards for computer system design, implementation, and validation.
  • Knowledge of cGxP/QSR, GAMP, ICH, EMA, and FDA guidelines.
  • Experience with application system validation and infrastructure qualification.
  • Proficient in Microsoft Office Suite.
About Shionogi Inc.

Shionogi Inc. is an equal opportunity/affirmative action employer. We are committed to creating a diverse and inclusive work environment that values and respects all employees.



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