Global Validation Lead — Manufacturing Compliance

MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054); Selangor; On-site; MYR 180,000 - 240,000; Full time

Job summary

Novartis, based in Selangor, Malaysia, is seeking a Validation Lead to drive robust validation strategies across manufacturing operations. You will coordinate cross‑functional teams and global stakeholders to ensure compliant processes and lifecycle management for high‑quality medicines.

The role emphasizes leading investigations, approving critical documentation, and advancing continuous improvement initiatives within a regulated environment.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• Two to eight years of experience within a biopharmaceutical or pharmaceutical manufacturing environment.
• Strong understanding of manufacturing processes and associated production equipment.
• In-depth knowledge of quality systems and regulatory requirements across multiple health authorities.
• Experience executing process validation and/or cleaning validation activities in a regulated environment.
• Demonstrated expertise in technical report writing, document review, and cross‑functional project management.

Responsibilities

• Developing validation documentation to support compliant manufacturing processes and lifecycle management.
• Executing process and cleaning validation strategies aligned with regulatory and quality requirements.
• Coordinating validation activities with cross-functional teams to ensure timely and effective execution.
• Providing validation support for manufacturing processes serving global markets, including Singapore-related operations.
• Leading investigations and supporting resolution of validation deviations, observations, and technical issues.
• Reviewing and approving validation protocols, reports, risk assessments, and related technical documentation.
• Driving continuous improvement initiatives to enhance validation effectiveness, compliance, and operational performance.
• Managing validation projects and stakeholder engagement across multiple functions and sites.

Education

Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or related field

Two to eight years of experience in biopharmaceutical or pharmaceutical manufacturing

Job description

Novartis, based in Selangor, Malaysia, is seeking a Validation Lead to drive robust validation strategies across manufacturing operations. You will coordinate cross‑functional teams and global stakeholders to ensure compliant processes and lifecycle management for high‑quality medicines.

The role emphasizes leading investigations, approving critical documentation, and advancing continuous improvement initiatives within a regulated environment.