Key Results Areas:
• On-time execution of site validation plans across all functions and systems.
• Zero critical or major validation observations during regulatory inspections.
• Effective planning and resource coordination across departments to meet project and production goals.
• Improved capability and performance across the validation teams.
• Continuous improvement in validation strategy and reduction in cycle times or redundant effort.
• Lead and develop a high-performing, multi-disciplinary team with the goal to maintain the validated state of equipment across site.
• Define training and development frameworks, including capability matrices, coaching plans, and individualized development pathways.
• Drive technical excellence and succession planning through structured assessments and ongoing mentoring.
• Ensure training records and technical competencies are current across all team members.
• Continuously develop in-depth knowledge of the relevant regulations, industry standards and technical requirements. Improve skills and know how in validation / qualification. Actively engage with industry forums and ensure knowledge is up to date as regulations or recommended practices change.
• Identification of key skill sets required for the validation team roles and ensuring that each team member is well-equipped to perform their tasks with confidence.
• Develop and deploy training plans, mentoring and coaching as required. Supporting each team member with their own personal development plan as it relates to technical ability.
• Provide strategic oversight and in depth understanding of temperature mapping and smoke visualisation qualification activities including equipment, utilities, and controlled environments across the site.
• Ownership, development and delivery of site equipment re-qualification schedule and integration into the site Validation Master Plan (VMP), ensuring alignment with global Teva standards, cGMP, and regulatory expectations.
• Provide approval on validation protocols and reports across equipment, utilities and controlled environments.
• Lead planning and execution of Annual, Quarterly, and Monthly validation and requalification schedules across all system types.
• Ensure a risk-based approach to validation activities, embedding industry best practices and emerging regulatory guidance.
• Accountable for the development and maintenance of site validation templates, ensuring alignment with corporate standards and best practices.
• Drive data-driven validation planning through risk assessments, performance trends, and periodic review findings.
• Coordinate day-to-day validation activities across shifts and functions to ensure efficient execution against the agreed plan.
• Collaborate closely with Operations, MS&T, Quality, Engineering, supply chain and IT to align validation schedules with manufacturing priorities and project timelines.
• Monitor progress against key milestones, escalate barriers, and adjust plans dynamically in response to changing site needs.
• Serve as a validation leader, chairing stakeholder meetings to ensure transparency of team capacity, risks, and deliverables.
• Ensure validation activities are compliant with cGMP, GEP, and applicable Teva Standards and global regulatory expectations.
• Maintain audit readiness at all times; lead preparation for and participate in internal and external inspections.
• Own the validation-related CAPAs, Deviations, and Change Controls (DRs, CCMs), ensuring timely closure and zero overdue metrics.
• Lead validation response to audits and inspections, providing data, records, and SME representation as needed.
• Ensure validation documentation is complete, audit-ready, and reflective of current regulatory requirements.
• Drive improvements in validation strategy, templates, processes, and documentation.
• Demonstrated ability to challenge current processes and procedures to drive continuous improvements whilst maintaining regulatory compliance.
• Regularly review equipment performance, including Steam-in-Place systems, thermal mapping data and smoke visualisation and implement system upgrades or process enhancements.
• Shadow validation team to identify gaps or improvement opportunities in equipment, documentation, and working practices.
• Promote and uphold a proactive EHS culture across all validation activities.
• Ensure procedures, plans, and work practices are aligned with safety expectations.
• Actively participate in tier meetings, site KPI tracking, and EHS event reporting.
• Generate relevant summary information for presenting at SQC and attend as appropriate.
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