CSV/CQV Life Sciences Practice Leader

Life Sciences CSV / CQV Practice Leader

Role Overview

This role is responsible for building and scaling an organic CSV and CQV practice focused on regulated life sciences environments. The position is designed for a senior validation leader who can establish a new capability from the ground up, beginning with key hires and growing into a scalable, project‑ready team supporting complex pharma and biotech programs.

The successful candidate will lead large‑scale validation programs, define best practices and standards, support client growth, and take ownership of developing a sustainable CSV/CQV "mini business" within a broader engineering and technology organization.

This is a senior, entrepreneurial leadership role that combines deep validation expertise, people leadership, and commercial accountability.

Key Responsibilities

Practice & Team Development

• Build and scale an organic CSV/CQV capability, starting with initial hires and expanding into a dedicated, multi‑discipline validation team.
• Recruit, mentor, and develop CQV and CSV engineers, setting clear expectations for quality, compliance, delivery, and utilization.
• Establish standardized validation templates, protocols, procedures, and delivery frameworks to improve speed, consistency, and inspection readiness.
• Serve as the senior validation authority across life sciences engagements.

Technical & Delivery Leadership

• Lead large‑scale CQV and CSV programs for site start‑ups, expansions, tech transfers, and major remediation initiatives.
• Provide subject‑matter expertise across CQV disciplines, including facilities, utilities, process equipment, and automation systems.
• Oversee validation deliverables such as VMPs, URS, risk assessments, and execution of IQ, OQ, and PQ activities.
• Lead CSV efforts for GxP systems including MES, LIMS, QMS, DCS/PLC platforms, and data historians, ensuring compliance with 21 CFR Part 11 and data integrity expectations.
• Define and execute risk‑based validation strategies, including deviation management, change control, periodic review, and inspection readiness support.

Client Engagement & Growth

• Act as a trusted validation advisor to client stakeholders across Quality, Quality Systems, Regulatory, Manufacturing, Automation, and Global Validation leadership.
• Represent the validation function confidently during audits and regulatory inspections.
• Support pre‑sales activities, including shaping validation strategies, defining scope, developing effort estimates, and supporting client presentations.
• Grow client relationships from single projects into long‑term, multi‑site or multi‑year validation programs.

Commercial & Entrepreneurial Ownership

• Take accountability for delivery performance, revenue, utilization, margins, and overall practice health.
• Manage scope, change controls, timelines, and budget while maintaining compliance and inspection readiness.
• Operate with an ownership mindset, comfortable building a validation practice from a low base and scaling responsibly over time.

Required Experience & Background

Core Experience

• 10-15+ years of experience in life sciences manufacturing environments (biologics, sterile/aseptic, vaccines, high‑potency) with a strong cGMP track record.
• 8-10+ years focused specifically on CQV and CSV in pharma or biotech, with progression from validation engineer to technical lead or manager.
• Recent leadership of large‑scale site start‑ups, expansions, or major tech‑transfer validation programs.

Leadership & Prior Roles

• Previous roles may include CQV/CSV Manager, Senior Manager, Project Director, or Head of Validation within a large pharma/biotech organization or validation‑focused consultancy/system integrator.
• Demonstrated experience leading cross‑functional validation teams, including internal staff and contractors.
• Proven ability to hire, develop, and performance‑manage validation engineers and specialists to big‑pharma standards.

Technical Expertise

• Deep understanding of CQV for facilities, utilities, process equipment, and automation systems.
• Strong CSV background covering regulated GxP systems and data integrity requirements.
• Experience standardizing validation processes and leveraging electronic validation platforms such as Kneat, ValGenesis, or Veeva (preferred).

Desired Attributes

• Maintains a strong professional network of CQV and CSV professionals that can be leveraged to build a scalable team within 6-12 months.
• Comfortable creating and enforcing validation standards that balance compliance, speed, and quality.
• Strong communicator with credibility across QA, regulatory, engineering, and operations teams.
• Naturally entrepreneurial, motivated by building teams, capabilities, and long‑term value.

Location

• US‑based, preferably located in or near a major life sciences hub such as Boston/Cambridge, NYC/Northern NJ, Philadelphia, RTP, the Bay Area, Chicago, or the MD/DC corridor.