QA Validation Lead - Compliance, Strategy & Impact

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline Singapore is seeking a QA professional to lead validation activities for major projects, ensuring compliance with quality systems and strong cross-functional collaboration with manufacturing. You will drive validation strategy across cleaning and process validation and support product submissions.

The role emphasizes practical problem solving, integrity, and patient safety, offering career growth and a hands-on impact on compliant supply in a fast-paced biopharma environment.

Qualifications

• Bachelor’s degree in science, engineering or related discipline or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical quality assurance, validation or related roles.
• Practical knowledge of cGMP and regulatory requirements.
• Experience in authoring and approving validation documents and SOPs.
• Experience in assessing impact of changes, deviations and corrective actions on validation status.
• Strong communication skills with the ability to work effectively across stakeholders of different functions.

Responsibilities

• Provide QA oversight for validation projects covering cleaning validation 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, ensuring timely, compliant closure.
• Provide subject-matter expertise to cross-functional teams (Engineering, Operations, IT, Regulatory) on validation strategy and execution.
• Support in preparing validation documentation and responding to technical queries for product submission.
• Apply up-to-date knowledge of regulatory guidance (cGMP, 21 CFR Part 11, ICH) and ensure validation practices reflect industry best practice.

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

Job description

GlaxoSmithKline Singapore is seeking a QA professional to lead validation activities for major projects, ensuring compliance with quality systems and strong cross-functional collaboration with manufacturing. You will drive validation strategy across cleaning and process validation and support product submissions.

The role emphasizes practical problem solving, integrity, and patient safety, offering career growth and a hands-on impact on compliant supply in a fast-paced biopharma environment.