Job
Description
Accountabilities Responsible for ensuring that GxP regulatory compliance requirements on Global Patient Safety owned computerized systems that support GxP regulated business processes are understood and met. Provide Quality Management oversight of computerized systems owned by Global Patient Safety, ensuring GxP requirements are considered, and necessary validation documents are clear, complete, and retrievable. Offer Quality Management expertise for Global Patient Safety owned systems to ensure they meet all relevant GxP requirements and quality standards. Maintain an overview of the Global Patient Safety system estate from a QM perspective and a high-level view of system changes. Approve the Regulatory Impact Determination (RID) for all PS CoE-owned systems and provide expertise in generating the RID to determine GxP impact and validation needs. Review and approve User Requirements Specification for all PS CoE-owned systems, ensuring GxP-related requirements are included and clearly identified. Provide input to the high-level risk assessment process to ensure GxP impact risks are managed. Review and approve the Validation Plan for all Global Patient Safety owned systems, ensuring planned activities address GxP requirements. Approve User Acceptance testing. Sign off all Global Patient Safety owned systems into use via approval of the Validation Report, providing evidence to support compliance status. Participate in project audits, quality management reviews, and inspections as necessary, providing an independent quality voice. Contribute to the overall quality of PS CoE-owned systems by collaborating with business and RD IT teams responsible for system maintenance and upgrades. Ensure overall system quality through early deviation detection and risk reduction. Maintain up-to-date knowledge of internal and external regulations pertaining to computer system validation with an emphasis on GxP processes, recommending changes as necessary. Work closely with the RD IT Quality Manager and Business Project Manager on each project to ensure understanding of potential GxP impacts. Essential Skills/Experience Bachelor s degree or equivalent experience within the pharmaceutical or IT industries. Significant Experience (10+ years) of computer system validation in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc., and knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure. Good understanding of current system development lifecycle methodologies. Proven skills in formulating an independent and objective recommendation. Experience of how to determine, reach and maintain acceptable quality levels. Experience of performing, reviewing and approving risk assessments. Clear evidence of organizational skills. Desirable Skills/Experience Ability to proactively identify potential compliance issues and subsequently advise on their avoidance / resolution / remediation. In-depth knowledge of current developments in the pharmaceutical industry and global regulatory environment, and their potential impact on regulatory compliance, pharmacovigilance, signal and risk management activities, safety value demonstration, and safety science-related activities. Experience of delivering enhancement projects for a GxP, ER/ES, GVP or other regulated system. Key capability requirements: Understanding and management of risk Building relationships across cultures, functions, and disciplines Keen analytic and problem-solving skills Strong focus on quality
