GSK
biopharma
QAValidationManager
Neural analysis suggests this role is
optimal for Senior candidates.
“QA Validation Manager at GSK. Skills: QA oversight, Validation, Quality systems. Lead validation program. Develop procedures”
What You'll Achieve.
Ensure compliance with company policies; Ensure compliance with cGMP; Ensure compliance with regulatory expectations; Improve validation delivery; Ensure operational compliance; Meet cGMP expectations; Mitigate risks to acceptable levels; Increase validation efficiency; Reduce rework; Strengthen compliance
Industry & Context.
Risk-based decision making; Investigation; Solve complex investigations; Solve high impact investigations
What They're Looking For.
Must Have
10 years in the pharmaceutical industry, 5 years hands-on validation, 5 years leading validation activities/teams, GMP knowledge, validation lifecycle knowledge, CSV knowledge, Ability to apply risk-based, science-led decision making
Nice to Have
Formal quality/validation training, Lean/Six Sigma training, Ability to apply risk-based validation and quality assurance standards, Ability to facilitate business activities compatible with international regulatory environment, Ability to solve complex / high impact investigation, Experience in global network alignment, Cross-site governance experience, Track record of building site capability, Delivering training programs
What You'll Do.
Lead validation program
Develop quality systems
Provide technical QA oversight
Ensure GxP activities operate under quality systems
Drive validation KPIs
Drive risk mitigation
Drive CAPA effectiveness
Champion continuous improvement
Maintain validation procedures
Maintain validation templates
Support cross-functional validation planning
Monitor system performance
Share regulatory knowledge
Share industry best practice
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 change control
Provide QA input to investigations
Provide QA input to CAPAs
Ensure MSAT operations have quality systems
Oversee method validation
Oversee method verification
Oversee method transfers
Oversee laboratory data integrity
Ensure Engineering GxP activities governed by quality system
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
Use capacity management
Define resource requirements
Prepare resourcing plans
Escalate resource risks
Escalate scheduling risks
Train QA validation team
Develop QA validation team
Identify compliance risks
Provide guidance for continuous improvement
Support continuous improvement
Increase validation efficiency
Strengthen compliance
How You'll Work.
Team & Collaboration
Collaborate with Engineering; Collaborate with Tech Services; Collaborate with MSAT; Collaborate with Analytical Science; Collaborate with cross-functional stakeholders; Interface with internal stakeholders; Interface with global teams; Represent QA in cross-functional forums
Communication Scope
Excellent communication skills
Process & Methodology
Capacity management, Plan validation activities, Prioritise validation workload, Manage team workload, Prepare resourcing plans
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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