GSK
Pharmaceutical
QAValidationManager
Neural analysis suggests this role is
optimal for Manager candidates.
“QA Validation Manager at GSK. Skills: Quality oversight, Validation, Compliance. Lead site validation program. Develop validation procedures”
What You'll Achieve.
Ensure compliance with policies; Ensure compliance with cGMP; Ensure compliance with regulatory expectations
Industry & Context.
Investigations; Risk mitigation
What They're Looking For.
Must Have
Degree in science or engineering, 10+ years in pharmaceutical industry, 5+ years hands-on validation, 5+ years leading validation teams, GMP knowledge, Validation lifecycle knowledge, CSV knowledge
Nice to Have
Formal quality/validation training, Lean/Six Sigma training, Apply risk-based validation, Apply quality assurance standards, Facilitate business activities, Solve complex investigations, Experience in global network alignment, Experience in cross-site governance, Track record building site capability, Track record delivering training programs
What You'll Do.
Lead site validation program
Develop validation procedures
Develop validation protocols
Develop validation quality systems
Provide technical QA oversight
Oversee process/method validation
Oversee CSV activities
Oversee continued verification
Ensure GxP activities operate robustly
Drive validation KPIs
Drive risk mitigation
Drive CAPA effectiveness
Mentor QA validation team
Build capability across resources
Prioritize validation workload
Champion continuous improvement
Develop validation templates
Support cross-functional validation planning
Ensure operational compliance
Generate validation metrics
Analyze validation metrics
Report validation metrics
Monitor validation system performance
Maintain regulatory knowledge
Maintain industry best practice knowledge
Establish validation training
Sustain validation training
Build site capability
Ensure personnel fulfil roles
Identify compliance risks
Implement risk mitigation actions
Ensure TECH operates under quality system
Provide QA input to TECH change control
Provide QA input to TECH investigations
Provide QA input to TECH CAPAs
Ensure MSAT operations have quality systems
Ensure Analytical labs have quality systems
Oversee method validation
Oversee method verification
Oversee method transfers
Oversee laboratory data integrity
Ensure Engineering GxP activities governed
Provide QA oversight for qualification
Provide QA oversight for commissioning
Provide QA oversight for lifecycle management
Create effective interfaces
Maintain effective interfaces
Represent QA in forums
Align site validation activities
Prioritize team workload
Define resource requirements
Prepare resourcing plans
Escalate resource risks
Escalate scheduling risks
Train QA validation team
Develop QA validation team
Identify compliance risks
Monitor training effectiveness
Close competency gaps
Provide guidance for continuous improvement
Support continuous improvement
Increase validation efficiency
Strengthen compliance
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Global teams; Internal stakeholders
Full Job Description
We are seeking a QA Validation Manager to provide site-level quality oversight of validation and qualification activities across manufacturing processes, equipment, facilities, computerized systems, and analytical laboratories. The role ensures compliance with company policies, cGMP and regulatory expectations by collaborating with Engineering, Tech Services, MSAT, Analytical Science and cross‑functional stakeholders to plan, execute and continuously improve validation delivery. What you’ll do * Lead and govern the site validation program: develop procedures, protocols and validation quality systems. * Provide technical QA oversight for process/method validation, CSV and continued verification activities. * Ensure TECH, MSAT, Analytical labs and Engineering GxP activities operate under robust quality systems. * Drive validation KPIs, risk mitigation, investigations and CAPA effectiveness. * Mentor and build capability across the site; plan resources and prioritise validation workload. * Champion continuous improvement using GSK Production System, Tiers, Gemba and DMAIC principles. **Key responsibilities** Quality oversight — Validation & qualification * Develop, maintain and govern effective validation procedures, templates and associated quality systems to manage all site validation activities. * Support cross‑functional validation planning and provide QA oversight to ensure operational compliance using a science‑ and risk‑based approach (e.g., process validation, method validation, continued process verification, continued method verification). * Generate, analyse and report metrics to monitor validation system performance and drive improvements. * Maintain and share up‑to‑date knowledge of regulatory requirements and industry best practice related to validation. * Establish and sustain validation training to build site capability and ensure personnel fulfil defined roles and responsibilities. * Identify compliance risks linked to site facilities and systems and i
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