Sr. Manager-MSAT (Validation)

Role Overview

This senior validation leadership role is focused on overseeing the full qualification and validation program for equipment, facilities, utilities, and computerized systems in a regulated manufacturing environment. The position requires strong ownership of compliance, documentation, cross-functional coordination, and continuous improvement across quality systems.

Key Responsibilities

• Direct the end-to-end validation lifecycle using the V-model, starting from user requirements and technical assessment through FAT, SAT, IQ, OQ, PQ, and periodic requalification.
• Ensure utilities such as purified water, water for injection, compressed gases, and nitrogen remain in a qualified state, and that cleanroom qualifications continue to meet ISO 14644 standards.
• Oversee calibration planning, including the basis for calibration rationale, setting acceptance criteria, determining intervals, and managing outsourced calibration work.
• Lead computerized system validation for quality control, manufacturing, and utility-related applications, ensuring new critical systems are aligned with 21 CFR Part 11 expectations.
• Assign and coordinate work across validation subject-matter experts to support qualification and validation execution.
• Manage quality system activities such as change control, deviation investigations, CAPA, and audit support, while providing technical input on validation matters.
• Work closely with cross-functional teams to monitor product lifecycle status and support compliance with country-specific registration requirements.
• Maintain control of validation records, including archiving, retrieval, and document distribution.
• Drive improvement and risk management initiatives, identify compliance gaps, and recommend structured corrective actions.
• Embed data integrity principles such as ALCOA+ across quality-related systems and processes.
• Support product life cycle validation activities including process validation, product remediation, sterilization validation, cleaning validation, gowning qualification, visual inspection, aseptic process simulation, and transport validation.
• Follow ISO 14001:2015 environmental management expectations and site HSE policies in day-to-day operations.
• Reduce environmental impact, maintain safe working practices, manage waste appropriately, use equipment safely, and report hazards or non-conformities when identified.

Competencies Expected

• Strong results orientation with clear accountability and ownership.
• High level of compliance discipline, initiative, flexibility, and attention to detail.
• Excellent communication, stakeholder management, and collaboration abilities.
• Proven leadership and people management capability.
• Strong planning, prioritization, organization, and adaptability skills.
• Ability to identify, reduce, and prevent environmental and operational risks.
• Active contribution to EHS activities, audits, and continual improvement efforts.

Qualifications and Functional Knowledge

• Bachelor’s degree in engineering (Mechanical, Electrical, or Mechatronic) or a pharmacy/science background with a master’s qualification in science or pharmacy.
• 10 to 15 years of experience in qualification and validation.
• Good working knowledge of GMP, GDP, ISO 9001, and ISO 14001 requirements.
• Exposure to regulatory expectations from agencies and frameworks such as FDA, WHO, and EU.
• Hands-on experience with audits, CAPA, risk management, and QMS environments.
• Strong leadership, team management, analytical thinking, and problem-solving abilities.
• Proficiency in MS Office and electronic QMS platforms.

Additional Information

This role also requires strong document governance for validation records and a practical understanding of environmental, health, and safety responsibilities within a manufacturing site.