GMP Tech Audit Associate Director

Responsibilities:

• Perform internal audits of computerized systems including both enterprise and manufacturing site systems. External audits include suppliers providing software and technology services to Organon’s Manufacturing & Supply organization.
• Collaborate with key stakeholders such as Global Quality and Compliance, Technology Quality Assurance, BT, CISO, Procurement, Engineering, and Organon’s manufacturing sites.
• Ensure a risk-based approach towards profiling and selecting internal and external (vendor) audits/assessments.
• Develop and maintain procedures to deliver audit programs.
• Harmonize the GMP Tech audit program with the GMP audit program.
• Manage overall internal and vendor audit and assessment plans, schedules, communications, and stakeholder expectations.
• Execute internal and external audits/assessments globally on behalf of GQ surveying for compliance with regulatory requirements and company policy while leveraging BT Risk Management & Compliance (RM&C) principles.
• Deliver audit reports, including corresponding findings and remediation for tracking in a management reporting system.
• Ensure responses to each audit observation including corrective actions and/or process improvement element(s).
• Manage associated audit process and customer service exceptions
• Monitoring/Reporting service metrics (SLAs)
• Manage escalations and visibility of audits and assessment outcomes.
• Provide training delivery for audit and assessment programs.
• Identify and implement continuous improvement opportunities.
• Liaise with other audit and compliance groups and Corporate Internal Audit to coordinate global audit schedule and agree on audit scope criteria.
• Manage multiple projects / ongoing work activities of high complexity.
• Mentor junior audit staff.
• Monitor quality metrics and audit trends, identify compliance issues, and determine opportunities for quality improvements within GQ customer areas.
• Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches, and actions to effectively develop and advance audit strategies.
• Requires approximately 25% domestic and international travel for up to two weeks in duration.

Requirements:

• Bachelor's degree in Science, Information Technology, or equivalent IT experience related to IT Systems Development, Implementation and/or IT Operations.
• 5-7 years of auditing experience in a highly regulated environment.
• Extensive knowledge of the principles, theories, and concepts of computerized system auditing for compliance to GMP regulations.
• 2-5 years of experience in delivering validated IT solutions or an application support role.
• 2-5 years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
• Good understanding of technology operations
• CISA, CISSP Certification and knowledge of frameworks established under COBIT and ITIL.