Validation Lead

Reckitt • Wilson, NC

112d • $97,000 - $145,000

About The Position

The Quality Validation Lead is responsible for leading and integrating validation strategies across equipment, processes, and computerized systems to ensure compliance with global regulatory standards. This role is to ensure that all GxP systems and manufacturing processes are validated, audit-ready, and aligned with industry best practices.

Requirements

• Minimum BS Degree in Science or Engineering
• 5+ years of experience in QA validation, CSV, process validation and equipment qualification work experience in Pharmaceutical/Health industry
• Minimum of three years managing a team in Pharmaceutical/Health industry
• Experience in managing cross-functional teams and complex validation projects
• Expertise in regulatory guidelines (FDA, EMA, ICH Q7-Q10), GAMP 5, and data integrity principles
• Strong analytical, documentation, and communication skills
• Experience with validation software and enterprise systems (e.g., VeevaVault, Kneat Validation, SAP) and the ability to train and support superusers
• Experience in validated computer systems and knowledge of CSA / Data Integrity requirements
• Demonstrable track record of highly rated service, managing numerous requests, prioritizing work and managing time effectively
• Ability to effectively communicate difficult messages to senior management and present/collaborate on potential resolutions to support project deliverables
• Ability to identify non-compliance and failure risks on existing processes and operations and communicate potential options for resolution
• Able to operate in line with the Reckitt core values and Leadership behaviors

Nice To Haves

• CSV Strategy
• GxP Compliance
• SDLC Mastery
• Risk Assessment
• Process Validation
• Audit Readiness
• Change Control
• Technical Oversight
• Training Delivery
• Documentation Accuracy

Responsibilities

• Define and implement CSV and CSA strategies for GxP-regulated systems
• Lead validation of GxP-regulated computerized systems (e.g., LIMS, MES, ERP)
• Support SDLC documentation (including URS, FRS, IQ/OQ/PQ protocols, and validation reports) and validation lifecycle activities for computerized systems
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity standards
• Support qualification review of manufacturing and laboratory equipment (IQ/OQ/PQ)
• Review and approve equipment validation documentation and calibration records
• Ensure equipment remains in a validated state through periodic reviews and requalification
• Provide quality oversight in process validation activities including protocol development, execution, and reporting
• Conduct risk assessments and support change control evaluations for process changes
• Collaborate with Technical and Manufacturing teams to ensure validated state of processes
• Ensure corporate and regulatory compliance of validation master plans, protocols (IQ/OQ/PQ), and reports for equipment, utilities, and processes
• Collaborate with Project Engineers and the Technical team to provide Quality oversight of validation activities relating to computer systems, introduction of new equipment, and changes to current equipment
• Maintain validation documentation in accordance with internal SOPs and regulatory expectations
• Support risk assessments, change controls, investigations, CAPAs, and audit responses related to validation activities and associated continuous improvement initiatives
• Participate in internal and external audits and inspections
• Support the continuous development of site operations and improving the approaches for transfer and implementation of new technologies
• Deliver identified systems training to end users and super users to ensure competency and adherence to requirements
• Reviewing and managing requests for changes to in-scope systems and performing assessments to determine validity, following required change control procedures
• Ensure electronic systems and records and best practice technology remain fully compliant and continually improve effectiveness
• Perform the Quality review and approval responsibility of projects associated with computer systems and validation
• Provide Quality Technical support to investigations associated with computer systems where required

Benefits

• Parental benefits
• Employee Assistance Program to promote mental health
• Life insurance for all employees globally
• 401(K) plan
• Generous paid parental leave
• Adoption and fertility support
• Tuition reimbursement
• Product discounts
• Annual discretionary bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree