Validation Sr. Manager

Essential Duties and Responsibilities

• Develop, implement, and continuously enhance site or enterprise validation strategies aligned with regulatory expectations and business objectives.
• Lead lifecycle validation programs to sustain the qualified and validated state of facilities, utilities, systems, equipment, and manufacturing processes.
• Establish and maintain Validation Master Plans (VMPs), validation policies, and governance frameworks.
• Drive the adoption of risk‑based validation methodologies grounded in scientific and quality risk management principles.
• Champion continuous improvement initiatives to enhance compliance, operational efficiency, reliability, and inspection readiness.
• Ensure validation strategies support commercial manufacturing continuity, new product introductions, and organizational growth.
• Provide leadership and oversight across validation disciplines, including equipment qualification (DQ, IQ, OQ, PQ), process validation and continued process verification (CPV), cleaning validation, contamination control strategies, facility and utility qualification, HVAC systems, computerized system validation (CSV), packaging and labeling validation, environmental monitoring, aseptic process validation, and CQV activities.
• Review and approve validation protocols, reports, acceptance criteria, and technical justifications.
• Ensure timely execution of validation deliverables in alignment with operational priorities and capital projects.
• Oversee deviations, investigations, change control processes, risk assessments, and remediation activities related to validation systems.
• Ensure data integrity standards and documentation practices are compliant with current cGMP expectations.
• Ensure compliance with global cGMP regulations, regulatory agency expectations, and industry guidance.
• Lead validation readiness efforts for regulatory inspections, customer audits, and internal assessments.
• Serve as subject matter expert (SME) during inspections and audit engagements.
• Partner with Quality and Compliance teams to address CAPAs, deviations, audit observations, and remediation plans.
• Ensure validation activities align with data integrity requirements and quality risk management principles.
• Lead, coach, and develop validation managers, engineers, specialists, and technical staff.
• Establish departmental goals, performance metrics, staffing plans, and succession strategies.
• Manage departmental budgets, contractor resources, and prioritization of validation activities.
• Foster a high‑performance culture emphasizing accountability, collaboration, technical excellence, and compliance.
• Collaborate cross‑functionally with Manufacturing, Engineering, Quality, Regulatory, Automation, Supply Chain, and Project Management teams to support new product introductions, technology transfers, facility expansions, startup activities, capital projects, process optimization, continuous improvement, and product lifecycle management.
• Provide validation expertise and guidance during deviations, investigations, change management, risk assessments, and remediation programs.
• Establish and maintain validation governance frameworks to ensure consistency in validation standards, methodologies, and lifecycle execution.
• Lead validation review boards, governance forums, and escalation pathways as appropriate.
• Ensure alignment of validation practices across departments and, where applicable, enterprise operations.
• Perform any other tasks/duties as assigned by management.

• Bachelor's degree in Life Science, Engineering, or a related field.
• Minimum 8 years performing Validation Activities in Pharmaceutical or related industry.
• Minimum 5–8 years management experience.
• Strong knowledge of cGMP regulations and practices pertaining to validation principals, aseptic manufacturing processes, automated process control and monitoring systems, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
• Experience with Annex1 contamination control strategies, data integrity programs, major capital expansion projects, technology transfers and regulatory/inspection remediation efforts…