Validation Lead (Wilson, NC, US, 27893)

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

​Research & Development​

Our supply chain is the backbone of our business. It's how we get our trusted products to people all over the world, safely and efficiently. And it's our talented and passionate teams that make this happen.

If you're looking for a career in supply chain, there's no better place to be than Reckitt. We offer a variety of exciting opportunities in all areas of the supply chain, from planning and procurement to manufacturing and logistics. You could join our Global Supply Planning team to develop and implement our global supply strategy, or work with our Procurement Centre of Excellence team to negotiate and manage our supplier relationships.

Our Manufacturing Excellence team help us improve the efficiency, quality and safety of our manufacturing operations, and our Logistics Excellence team develop new and innovative ways to distribute our products to customers.

About the role

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.

This role is not currently sponsoring visas or considering international movement at this time.

Your responsibilities

Computer System Validation (CSV)

• 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.

Equipment Qualification

• 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.

Process Validation

• 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.

Quality Assurance Support

• 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 to ensure timely completion of validation project deliverables according to the Site Validation Master Plan.
• 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.
• Ensures 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. 

The experience we're looking for

• 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 

The skills for success

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

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.

We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognize, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Salary Range

Range for the role:  97,000 – 145,000

Hiring range for the role:  97,000 – 120,000

Pay Transparency

The base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law.  In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year. Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, life and disability insurance; paid time off for vacation, sick, and Company recognized holidays; a 401(K) plan; generous paid parental leave; adoption and fertility support; tuition reimbursement; product discounts; and much more! If reasonable accommodation is needed to complete your application, please contact NAtalentacquisition@reckitt.com. Reckitt is committed to the full inclusion of all qualified individuals.

Equality

We recognize that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; color, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.