CSV/CSA Strategy Leader – Validation Excellence

PerkinElmer; Quinte West; On-site; CAD 246,000 - 271,000; Full time

Job summary

Project Farma, a PerkinElmer company, is seeking a Senior Director, CSV to lead the Validation Services practice with a focus on CSV/CSA strategy, standards, and enterprise alignment. The role involves guiding multiple teams, advancing regulatory compliance, and shaping cross-functional programs across the organization.

The Senior Director will drive training, process modernization, and business development, balancing short-term execution with long-term growth, while ensuring patient-focused

Qualifications

• 15+ years advanced therapy, life science, pharmaceutical, or biotech experience.
• 10 years minimum managing high-performing teams.
• 6 years minimum business development, lead generation, or sales experience.
• Travel as needed to fulfill business development and training initiatives.

Responsibilities

• Define and enforce CSV/CSA standards, methodologies, and templates across the practice.
• Serve as the enterprise CSV/CSA authority on regulatory expectations (21 CFR Part 11, EU Annex 11, GAMP 5).
• Lead training across the organization and manage competency and certification status.
• Guide modernization of the CSV/CSA practice and drive automation and digitization.
• Identify and pursue CSV/CSA engagements; own RFP responses and client expansions.
• Lead CSV delivery with technical direction on validation deliverables and risk assessments.
• Mentor CSV team members and develop leadership for succession planning.

Skills

Technical depth

Innovation

Customer focus

Integrity

Collaboration & communication

Project execution

Growth mindset

Education

Bachelor’s Degree (and/or Masters) in Life Science/Engineering

Job description

Project Farma, a PerkinElmer company, is seeking a Senior Director, CSV to lead the Validation Services practice with a focus on CSV/CSA strategy, standards, and enterprise alignment. The role involves guiding multiple teams, advancing regulatory compliance, and shaping cross-functional programs across the organization.

The Senior Director will drive training, process modernization, and business development, balancing short-term execution with long-term growth, while ensuring patient-focused