Validation - Senior Director, CSV

About this role

When joining PerkinElmer, 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 OneSource 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 PerkinElmer 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.

Key Responsibilities 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, technologies, and methodologies that improve validation efficiency, documentation quality, and client outcomes • Monitor the regulatory landscape (FDA, EMA, ICH) and proactively adapt practice standards to maintain compliance and competitive relevance • Drive automation, digitization, and standardization of validation workflows and documentation processes • Share industry insights and emerging best practices across the organization to elevate technical excellence and position Project Farma as an industry leader in CSV/CSA

Business Growth & Development • Identify, pursue, and close new CSV/CSA engagements by leveraging industry networks, client relationships, and deep practice expertise • Own and lead responses to RFPs and proposals for CSV-related services, collaborating with business development and practice leadership as needed • Develop and expand existing client accounts within the CSV space, identifying opportunities for scope growth and service expansion • Represent Project Farma at industry events, conferences (e.g., ISPE, PDA), and regulatory forums to build brand recognition and generate new business opportunities • Collaborate across Project Farma practice teams to develop integrated solutions for joint business opportunities that meet client and firm objectives • Maintain business development activity and pipeline data within the firm's customer relationship management (CRM) system • Speak at multiple industry events and publish insights in reputable publications

Leadership & Talent Development • Lead, mentor, and develop CSV team members, providing technical guidance, career development support, and performance feedback • Support the growth, maintenance and development of CSV delivery teams, with input for hiring, onboarding, talent management, and terminat

Similar jobs

• Validation - Senior Director, Process & Cleaning Validation — Newperkinelmer · Customer Site - IN
• Manager, Computer Systems Validation (CSV) — Corcepttherapeutics · Redwood City, California, United States
• Senior Director System Validation Engineer — Asteralabs · San Jose, CA
• Data Validation Risk - Senior Associate — PwC · NY-New York | GA-Atlanta | NC-Charlotte
• Data Validation Risk - Director — PwC · NY-New York | GA-Atlanta | NC-Charlotte
• Senior Quality Assurance Validation Specialist — Regeneron · RENSS - TEMPEL LN
• IT Senior Data Quality Analyst — KeyBank · Brooklyn, OH
• Director, Compliance and Validation — Barry-Wehmiller · East Brunswick, NJ