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Senior, niche CSV leadership in a regulated pharma context reduces but doesn't eliminate applicant density.
Requires deep GxP/CSV and life-sciences regulatory expertise, making skills poorly transferable across industries.
Explicit 12+ years CSV, regulatory mandates, and leadership experience create highly rigid hiring filters.
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Lead and manage a team responsible for computer system validation, QC systems, and IT problem/deviation management ensuring compliance with industry and regulatory standards.
Oversee and align PDS enterprise function activities, develop and improve quality and validation processes, and coordinate with cross-functional teams and vendors to meet organizational goals.
Collaborate with senior leadership to define strategies, monitor vendor performance, and report on quality and validation initiatives to drive continuous improvement.
B.E./B.Tech. or equivalent degree; Master’s preferred in computer science, data science, business administration, or related field.
12+ years experience in computer system validation in life sciences including at least 4 years in a leadership role.
Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211, 58, 312, 50, 56), data integrity, GAMP, Agile methodologies, and experience with large regulated enterprise systems (e.g., CMMS, LIMS).
Experience managing teams, vendors, multiple projects and vendor contracts; Fluent professional proficiency in English.
Experienced leader with demonstrated ability to manage and motivate cross-functional teams and vendors towards compliance and quality objectives.
Proficient in driving validation strategies and quality processes across regulated pharmaceutical IT environments using industry standards and risk management.
Skilled in stakeholder engagement and communication with senior leadership, adept at managing complex projects within regulated, enterprise-scale life sciences contexts.