Senior QA Validation Lead - Clean & Process Validation

GlaxoSmithKline plc; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

GSK Singapore is seeking a QA professional to lead validation activities for major projects, ensuring adherence to quality systems. You will collaborate with Manufacturing, Engineering and Regulatory teams to drive validation strategy and compliant execution, with emphasis on cGMP and regulatory alignment.

The role requires strong communication, problem‑solving and technical writing as you support Product submissions and continuous process verification approaches in a fast‑paced, patient‑focused

Qualifications

• Bachelor’s degree or equivalent experience in science, engineering or related field.
• Minimum 5 years in pharmaceutical QA, validation, or related roles.
• Practical knowledge of cGMP and regulatory requirements.
• Experience authoring and approving validation documents and SOPs.
• Experience assessing impact of changes, deviations and CAPAs on validation.
• Strong communication across multiple stakeholders.

Responsibilities

• Provide QA oversight for validation projects, including cleaning and process validation strategy and execution.
• Author, review and approve validation plans, protocols, reports and related SOPs.
• Assess validation impact for changes, deviations and investigations.
• Act as QA approver for deviations, CAPAs, change controls and SOPs; ensure timely closure.
• Provide SME guidance to cross‑functional teams (Engineering, Operations, IT, Regulatory).
• Assist in preparing validation documentation and responding to technical queries for product submissions.
• Apply up‑to‑date knowledge of regulatory guidance (cGMP, 21 CFR Part 11, ICH) and best practices.

Skills

Data integrity

Detail‑oriented

Digital fluency

GxP regulations

Influencing without authority

Lean management

Pharmaceutical regulatory compliance

Problem solving

Quality assurance (QA)

Risk awareness

Technical writing

Education

Bachelor’s degree in science, engineering or related discipline

Tools

Computerized system validation

Job description

GSK Singapore is seeking a QA professional to lead validation activities for major projects, ensuring adherence to quality systems. You will collaborate with Manufacturing, Engineering and Regulatory teams to drive validation strategy and compliant execution, with emphasis on cGMP and regulatory alignment.

The role requires strong communication, problem‑solving and technical writing as you support Product submissions and continuous process verification approaches in a fast‑paced, patient‑focused