Associate Director - Computer System Validation

Alcott Global has been retained by a leading global organization in the pharmaceutical and medical device manufacturing sector. This leadership role is responsible for providing strategic direction and oversight for the site's Validation function, including Computer System Validation (CSV), Cleaning Validation, Process Validation, Facility & Cleanroom Validation, Preventive Maintenance oversight, and lifecycle validation activities, while ensuring compliance with FDA regulations (21 CFR Parts 210, 211, and Part 11), EU GMP, EU Annex 1, ISO standards, ICH guidelines, and global quality requirements. As a key member of the site Quality Leadership Team, the Associate Director will drive validation strategy, regulatory readiness, risk-based compliance, and continuous improvement initiatives aligned with both global and site objectives.

The role will lead the site Validation Master Plan (VMP), oversee validation lifecycle activities across systems, equipment, processes, and facilities, ensure validated state throughout the product lifecycle, and provide strategic oversight for Computer System Validation, Cleaning Validation, Process Validation, New Product Introductions (NPI), Technology Transfers, Cleanroom Qualification, Facility Validation, and Preventive Maintenance programs. The individual will also work closely with Manufacturing, Engineering, Supply Chain, Quality Control, Regulatory Affairs, EHS, and other cross-functional teams to support compliant manufacturing operations, strengthen quality systems, and enable business objectives.

What we are looking for:

The ideal candidates will bring strong experience in pharmaceutical and/or medical device manufacturing, with a proven track record in Computer System Validation (CSV), Cleaning Validation, Process Validation, Facility & Cleanroom Validation, Validation Master Planning, Technology Transfer, New Product Introduction (NPI), risk-based validation, and regulatory compliance.

Key Responsibilities:

• Lead the site's end-to-end Validation Program, including development, implementation, and continuous improvement of the Validation Master Plan (VMP), ensuring all validation activities follow lifecycle validation principles and comply with FDA, EU GMP, ISO standards, and global quality requirements.
• Serve as the site Subject Matter Expert (SME) for Validation, providing strategic oversight across Computer System Validation (CSV), Cleaning Validation, Process Validation, Facility & Cleanroom Validation, and Preventive Maintenance programs while ensuring scientifically sound, risk-based validation approaches aligned with ICH Q9 principles.
• Lead Computer System Validation (CSV) activities, ensuring GxP computerized systems comply with 21 CFR Part 11, Annex 11, ALCOA+ data integrity principles, and global regulatory requirements, including oversight of LIMS, laboratory systems, infrastructure, applications, periodic reviews, and computerized system lifecycle management.
• Drive Cleaning Validation excellence by establishing robust validation strategies, scientifically justified acceptance criteria, worst-case product selection, continued verification programs, investigation management, and ongoing monitoring to maintain validated cleaning processes.
• Provide strategic leadership for Process Validation, New Product Introductions (NPI), and Technology Transfers, ensuring successful execution of Stage 1, Stage 2, Stage 3 Process Validation, IQ/OQ/PQ/PPQ protocols, Continued Process Verification (CPV), and validation support for product lifecycle management.
• Oversee Cleanroom, Facility, Utility, and Environmental Qualification activities, including HVAC systems, cleanroom classification, HEPA integrity testing, airflow visualization (smoke studies), ISO 14644 compliance, Annex 1 expectations, and controlled environment qualification and requalification programs.
• Drive Quality Systems, Regulatory Compliance, and Risk Management by ensuring effective management of Deviations, CAPAs, Change Control, Risk Assessments (ICH Q9), Validation Documentation, ALCOA+ Data Integrity principles, and acting as the Validation SME during FDA, EMA, and other regulatory inspections and audits.
• Build and develop a high-performing Validation organization by providing leadership, coaching, and technical mentorship, fostering a culture of accountability, ownership, execution, scientific excellence, compliance, and continuous improvement while strengthening technical capability across CSV, Process, Cleaning, and Facility Validation disciplines.
• Drive continuous improvement and strategic initiatives to strengthen validation effectiveness through enhanced validation lifecycle management, digital solutions, robust preventive maintenance integration, risk-based validation strategies, and close collaboration with Manufacturing, Engineering, Supply Chain, Quality, Regulatory Affairs, EHS, and cross-functional stakeholders.

Candidate Profile:

• 10+ years of relevant experience in Validation, Pharmaceutical Manufacturing, Biotech, or Medical Device Manufacturing.
• 5+ years of leadership experience managing validation teams, engineering programs, or site-level validation functions.
• Strong knowledge of FDA, EU GMP, ISO standards, ICH guidelines, 21 CFR Parts 210/211, 21 CFR Part 11, Annex 1, Annex 11, validation lifecycle principles, and data integrity expectations.
• Experience supporting regulatory inspections and interactions, including FDA inspections, EMA inspections, validation audits, and remediation activities.
• Strong ability to lead cross-functional teams, drive accountability, strengthen compliance culture, and support operational excellence.
• Pharmaceutical manufacturing experience is strongly preferred or required for select roles.
• Experience supporting New Product Introductions (NPI) and Technology Transfer programs is required.