Validation Sr. Manager

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Strategic Validation Leadership

• Develop and implement site or enterprise validation strategies aligned with operational, regulatory, and business objectives.
• Lead lifecycle validation programs to sustain the qualified and validated state of facilities, systems, utilities, equipment, and manufacturing processes.
• Establish and maintain Validation Master Plans (VMPs), validation policies, governance structures, and risk-based validation methodologies.
• Drive continuous improvement initiatives to enhance compliance, operational efficiency, reliability, and inspection readiness.
• Ensure validation strategies support commercial manufacturing continuity, product launches, and business growth.

Validation Program Oversight

Provide leadership and oversight for:

• Equipment qualification (DQ, IQ, OQ, PQ)
• Process validation and continued process verification (CPV)
• Cleaning validation and contamination control strategies
• Facility, utility, and HVAC qualification
• Aligns validation activities with (CSV) computerized system validation
• Packaging, serialization, and labeling validation
• Environmental monitoring and aseptic process validation support
• Commissioning, qualification, and validation (CQV) activities

Additional responsibilities include:

• Approve validation protocols, reports, acceptance criteria, and technical justifications.
• Ensure timely execution of validation deliverables supporting operational priorities and capital projects.
• Oversee deviations, investigations, change controls, risk assessments, and remediation activities associated with validation systems.
• Ensure data integrity and documentation practices meet current GMP expectations.

Compliance & Inspection Readiness

• Ensure compliance with current GMP regulations, industry guidance, and global regulatory expectations.
• Lead site validation readiness for regulatory inspections, customer audits, and internal compliance assessments.
• Serve as subject matter expert during regulatory inspections and audit interactions.
• Partner with Quality and Compliance teams to address CAPAs, deviations, observations, and remediation plans.
• Ensure validation systems align with quality risk management and data integrity expectations.

Leadership & Organizational Development

• Lead, coach, and develop validation managers, engineers, specialists, and technical staff.
• Establish departmental objectives, staffing plans, performance metrics, and succession planning initiatives.
• Manage department budgets, contractor resources, and prioritization of validation activities.
• Foster a high-performance culture emphasizing accountability, technical excellence, collaboration, and compliance.

Cross-Functional Collaboration

Partner with Manufacturing, Engineering, Quality, Regulatory, Automation, Supply Chain, and Project Management teams to support:

• New product introductions
• Technology transfers
• Facility expansions and startup activities
• Capital projects and equipment implementation
• Process optimization and continuous improvement initiatives
• Product lifecycle management
• Provide strategic validation guidance during deviations, investigations, change management, risk assessments, and remediation programs.

Technical Governance & Risk Management

• Establish and maintain risk-based validation frameworks using scientific and quality risk management principles.
• Govern validation standards, methodologies, and lifecycle execution across the organization.
• Ensure consistency in validation practices and technical decision-making.
• Lead validation review boards, escalation pathways, and governance forums as appropriate.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related scientific discipline required; advanced degree preferred.
• 10+ years of validation experience within regulated pharmaceutical, biotechnology, medical devices, or sterile manufacturing environments.
• 5+ years of leadership or people management experience.
• Strong expertise in qualification, process validation, cleaning validation, computerized systems, risk management, and GMP quality systems.
• Demonstrated success leading large-scale validation programs and cross-functional initiatives.
• Strong knowledge of global regulatory expectations and validation lifecycle concepts.

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

Physical Environment and Requirements

• Strategic leadership and organizational influence
• Validation lifecycle expertise
• Regulatory compliance and inspection readiness
• Quality risk management and problem-solving
• Technical writing and documentation excellence
• Program and project leadership
• Executive communication and stakeholder management
• Change leadership and continuous improvement

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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