Validation - Senior Director, CSV

When joining Perkin Elmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and One Source services.

Job Title Validation - Senior Director, CSV. Location(s) Customer Site - NJ. Job Description This is a full-time salaried position with Project Farma, a Perkin Elmer company. The successful candidate will be willing to travel domestically, to meet client project requests. Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle.

Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset.

The Senior Director, CSV is a senior leader responsible for setting direction, driving execution, and delivering results across the Validation Services Practice Area, with a technical focus on Computer System Validation/Computer Software Assurance (CSV/CSA). This role provides strategic leadership, oversees multiple teams or initiatives, and partners cross-functionally to align people, processes, and priorities with company objectives. This role is accountable for shaping strategy, leading leaders, and driving sustained business impact across a significant area of the organization, while influencing enterprise-level decisions, ensuring operational excellence, and developing leadership talent to balance short-term execution with long-term growth objectives.

• CSV Practice Leadership & Standardization Define and enforce consistent CSV/CSA standards, methodologies, and deliverable frameworks across the Validation Services practice area Serve as the enterprise subject matter authority for CSV/CSA, providing guidance on applicable regulatory expectations including 21 CFR Part 11, EU Annex 11, and GAMP 5 Develop and maintain practice-wide standard operating procedures, work instructions, and quality documentation templates to ensure consistent deliverable output Monitor practice performance and delivery quality across client engagements, identifying and resolving gaps in consistency or compliance Partner with Validation Services leadership and cross-functional practice teams to align CSV standards with firm-wide quality and operational objectives
• Training & Knowledge Development Design, implement, and continuously improve a comprehensive CSV/CSA training curriculum for Project Farma team members at all experience levels Deliver training sessions and knowledge transfer initiatives to build CSV competency across the organization Track and manage training completion, competency assessments, and certification status across the practice; provide regular reporting to leadership Onboard new team members into Project Farma's CSV methodology, standards, and quality expectations Partner with Practice Area leadership to align training programs with evolving regulatory requirements, client expectations, and industry best practices
• Innovation & Practice Modernization Lead the modernization of Project Farma's CSV/CSA practice, guiding the transition from traditional validation approaches to risk-based Computer Software Assurance (CSA) frameworks aligned with the FDA's finalized Computer Software Assurance guidance Identify, evaluate, and pilot innovative tools,…