Validation Sr. Manager

American Regent, Inc. • New Albany, OH

12d • Onsite

About The Position

The Validation Sr. Manager will develop, implement, and continuously enhance site or enterprise validation strategies aligned with regulatory expectations and business objectives. This role leads lifecycle validation programs to sustain the qualified and validated state of facilities, utilities, systems, equipment, and manufacturing processes. The position establishes and maintains Validation Master Plans (VMPs), validation policies, and governance frameworks, driving the adoption of risk-based validation methodologies. The Sr. Manager champions continuous improvement initiatives to enhance compliance, operational efficiency, reliability, and inspection readiness, ensuring validation strategies support commercial manufacturing continuity, new product introductions, and organizational growth. This role provides leadership and oversight across various 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. The Sr. Manager reviews and approves validation protocols, reports, acceptance criteria, and technical justifications, ensuring timely execution of validation deliverables. They oversee deviations, investigations, change control processes, risk assessments, and remediation activities related to validation systems, ensuring data integrity standards and documentation practices are compliant with current cGMP expectations and global cGMP regulations. The role leads validation readiness efforts for regulatory inspections, customer audits, and internal assessments, serving as a subject matter expert (SME) during these engagements. The Sr. Manager partners with Quality and Compliance teams to address CAPAs, deviations, audit observations, and remediation plans, ensuring validation activities align with data integrity requirements and quality risk management principles. Additionally, this role leads, coaches, and develops validation managers, engineers, specialists, and technical staff, establishing departmental goals, performance metrics, staffing plans, and succession strategies. They manage departmental budgets, contractor resources, and prioritization of validation activities, fostering a high-performance culture. Collaboration with cross-functional teams such as Manufacturing, Engineering, Quality, Regulatory, Automation, Supply Chain, and Project Management is essential to support new product introductions, technology transfers, facility expansions, startup activities, capital projects, process optimization, continuous improvement, and product lifecycle management. The Sr. Manager provides validation expertise and guidance during deviations, investigations, change management, risk assessments, and remediation programs, and establishes and maintains validation governance frameworks to ensure consistency in validation standards, methodologies, and lifecycle execution. They lead validation review boards, governance forums, and escalation pathways as appropriate, ensuring alignment of validation practices across departments and enterprise operations. Any other tasks/duties as assigned by management will also be performed.

Requirements

• Bachelors’ Degree in Life Science, Engineering, or a related field required.
• Minimum 8 years performing Validation Activities in Pharmaceutical or related industry required.
• Minimum 5 -8 years management experience required.
• 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.
• Strong knowledge of MS-Office software and PC Skills required.
• Good technical writing skills.
• Excellent communication, problem-solving, planning and organization skills.
• Ability to work independently with little supervision.
• Ability to function within a structured team environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work off hours and weekends as needed.

Nice To Haves

• Experience with Annex 1 contamination control strategies, data integrity programs, major capital expansion projects, technology transfers and regulatory/ inspection remediation efforts preferred
• Experience supporting sterile manufacturing, aseptic processing, biologics, cytotoxic products, or lyophilization operations, preferred

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.

Benefits

• Supporting patient health and enhancing the quality of life for animals are our guiding principles.
• Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.
• American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
• For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada.
• For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today.
• For over 30 years, we have supplied the leading joint health products for horses and dogs.
• We have locations in New York, Ohio, and California and sales territories nationwide.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior