Job
Description
Provide operational leadership and manage a team responsible for computer system validation, data governance, data management, and data quality across the organization. Oversee and coordinate resource activities related to computer system validation ensuring technology systems are designed and fit for their intended use in accordance with industry best practices and regulatory requirements. Develop, implement, and continuously improve data management and quality assurance processes. Liaise with the Functional Lead of Computer System Validation and the Head of Digital Strategy & Governance to ensure that initiatives are aligned across departments and that best practices are consistently followed. Foster strong relationships with cross-functional teams, vendors, and stakeholders to ensure smooth execution of data governance strategies. Ensure the team s alignment with organizational objectives by setting performance metrics and providing continuous feedback and coaching. Monitor vendor performance, including resources assigned by the vendor, ensuring service level agreements (SLAs) are met and any issues are addressed in a timely manner. Collaborate with senior leadership to define and implement data governance and quality strategies that support business needs. Contribute to the development and execution of training programs for staff and stakeholders. Prepare and present regular reports on data governance, quality, and validation initiatives to leadership, including progress updates, risks, and areas for improvement. People and Vendor Management Skills: Proven ability to manage, lead, and motivate teams of varying sizes, ensuring team cohesion and high performance. Experience in managing vendors and third-party relationships, ensuring alignment with organizational objectives and performance standards. Strong communication skills to manage both internal and external stakeholder expectations. Ability to foster a culture of collaboration, accountability, and continuous improvement. Experience in managing cross-functional teams and projects, ensuring alignment with strategic objectives. Demonstrated experience in managing team budgets and resource allocation including Standard Leader Work. Qualifications & Experience B.E./B.Tech. or equivalent in computer science, data science, business administration, or related field (Master s preferred) 7+ years of experience in computer system validation in the life sciences with at least 4 years in a leadership role. Strong understanding of data governance frameworks, data quality standards, and regulatory requirements (e.g.,21 CFR Part 210, 211, 58, 312, 50, 56). Experience with Computer System Validation (CSV) and familiarity with industry standards (21 CFR Part 11. Candidate must have a strong understanding of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP and Agile methodologies. Additionally, good understanding of Computer Software Assurance principles desired Certification in data governance (e.g., DGSA, CDMP) or project management (e.g., PMP) preferred but not required Proven track record in people management, including team development, coaching, and performance management. Experience managing vendor contracts and relationships. Knowledge of data management tools, systems, and platforms (e.g., database systems, data quality tools, reporting platforms). Strong project management skills, with experience overseeing multiple projects simultaneously. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, with the ability to present complex ideas to senior leadership. Understanding of quality risk-management concepts (ICH Q9) preferred Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes Experience with driving validation strategies across across the end-to-end product lifecycle as well as experience with widely used IT Enterprise platforms (SAP, Veeva, ServiceNOW etc.) General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools Candidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and Valgensis Ability to make decisions that impact own work and other groups/teams and works with minimal supervision Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team Demonstrates openness to learning and developing. Takes a responsibility for their own and team s development and growth Demonstrates an understanding of factors driving team performance and how they contribute to the teams overall success Strong sense of ethics, diplomacy and discretion Commitment to Quality
