Validation - Senior Director, CSVJob ID: REQ-058207Location: Trenton, NJJob Type: RegularThis 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 ResponsibilitiesCSV Practice Leadership & StandardizationDefine and enforce consistent CSV/CSA standards, methodologies, and deliverable frameworks across the Validation Services practice areaServe 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 5Develop and maintain practice-wide standard operating procedures, work instructions, and quality documentation templates to ensure consistent deliverable outputMonitor practice performance and delivery quality across client engagements, identifying and resolving gaps in consistency or compliancePartner with Validation Services leadership and cross-functional practice teams to align CSV standards with firm-wide quality and operational objectivesTraining & Knowledge DevelopmentDesign, implement, and continuously improve a comprehensive CSV/CSA training curriculum for Project Farma team members at all experience levelsDeliver training sessions and knowledge transfer initiatives to build CSV competency across the organizationTrack and manage training completion, competency assessments, and certification status across the practice; provide regular reporting to leadershipOnboard new team members into Project Farma's CSV methodology, standards, and quality expectationsPartner with Practice Area leadership to align training programs with evolving regulatory requirements, client expectations, and industry best practicesInnovation & Practice ModernizationLead 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 guidanceIdentify, evaluate, and pilot innovative tools, technologies, and methodologies that improve validation efficiency, documentation quality, and client outcomesMonitor the regulatory landscape (FDA, EMA, ICH) and proactively adapt practice standards to maintain compliance and competitive relevanceDrive automation, digitization, and standardization of validation workflows and documentation processesShare industry insights and emerging best practices across the organization to elevate technical excellence and position Project Farma as an industry leader in CSV/CSABusiness Growth & DevelopmentIdentify, pursue, and close new CSV/CSA engagements by leveraging industry networks, client relationships, and deep practice expertiseOwn and lead responses to RFPs and proposals for CSV-related services, collaborating with business development and practice leadership as neededDevelop and expand existing client accounts within the CSV space, identifying opportunities for scope growth and service expansionRepresent Project Farma at industry events, conferences (e.G., ISPE, PDA), and regulatory forums to build brand recognition and generate new business opportunitiesCollaborate across Project Farma practice teams to develop integrated solutions for joint business opportunities that meet client and firm objectivesMaintain business development activity and pipeline data within the firm's customer relationship management (CRM) systemSpeak at multiple industry events and publish insights in reputable publicationsLeadership & Talent DevelopmentLead, mentor, and develop CSV team members, providing technical guidance, career development support, and performance feedbackSupport the growth, maintenance and development of CSV delivery teams, with input for hiring, onboarding, talent management, and termination decisions in collaboration with Human ResourcesDevelop and implement employee performance and career development plans aligned with individual growth goals and practice objectivesLead succession planning initiatives to ensure the readiness of future CSV leaders within the practiceDrive firm-wide initiatives to share best practices, enhance retention, and foster a culture of technical excellence and continuous improvementTechnical DeliveryServe as the senior technical escalation point for complex CSV/CSA delivery challenges across client engagementsProvide technical direction and oversight on CSV deliverables, including validation master plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and summary reportsApply advanced knowledge of CSV/CSA principles to support client-specific requirements across a range of computerized systems (e.G., LIMS, MES, EBR, DCS, OSIsoft PI)Oversee project portfolios to ensure technical quality, regulatory compliance, timeline adherence,



and client satisfactionEnsure all CSV deliverables meet Project Farma quality standards and applicable regulatory requirementsOperational Performance & BillabilityMaintain a level of individual billability through direct client delivery while concurrently leading practice-level responsibilitiesMonitor and report on practice-wide financial performance, utilization, and delivery metrics to Validation Services leadershipSupport resource planning and workforce forecasting to meet project demands and practice growth targetsAttributes for SuccessTechnical Depth: Applies advanced technical knowledge and professional expertiseInnovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situationsIntegrity & Humility: Demonstrates self-awareness and puts PF mission above egoCollaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.Project Execution: Delivers reliably, manages priorities and drives for high quality outcomesGrowth Mindset: Shows openness to new ideas, feedback and changeExperience RequiredBachelor’s Degree (and/or Masters) in Life Science, Engineering, or related discipline (OR a combination of equivalent experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience)15+ years advanced therapy (cell and gene), life science, pharmaceutical, or biotech experience10 years minimum managing high-performing teams6 years minimum business development, lead generation, or sales experienceOther RequiredTravel as needed to fulfill Business Development and training initiatives.Experience operating as a trusted strategic advisor to organization decision-makers on short and long-term organizational initiatives.Experience translating client visions to set the direction, frame the project, provide clarity to direct reports and client, and deliver resultsProven technical/managerial capabilities in developing solutions to engineering and business problems and managing deliverables and client expectationsProject Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.The annual compensation range for this full-time position is $177,000 - 195,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.#J-18808-Ljbffr

📌 Validation - Senior Director, Csv (Quinte West)
🏢 PerkinElmer
📍 Quinte West