Biopharma Validation Lead – Strategy & Compliance

Novartis Malaysia; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Novartis Malaysia is seeking a Validation Lead based in Selangor to drive validation strategy and ensure compliant manufacturing processes for global medicines. You will coordinate across functions and global stakeholders to deliver robust validation programs.

You will lead investigations, review protocols and reports, and push continuous improvement across sites, supporting Singapore-related operations and complex projects in a highly regulated biopharma environment.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• 2–8 years of experience in 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.
• Fundamental understanding of pharmaceutical analytical testing methods and laboratory practices.
• Fluency in AI tools and technologies to support innovation and operational excellence.

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.

Skills

Validation leadership

Regulatory compliance

Process validation

Cross-functional PM

Education

Bachelor's or Master's degree in Chemistry,Biology, Pharmacy or Chemical Engineering

Tools

Quality systems

Job description

Novartis Malaysia is seeking a Validation Lead based in Selangor to drive validation strategy and ensure compliant manufacturing processes for global medicines. You will coordinate across functions and global stakeholders to deliver robust validation programs.

You will lead investigations, review protocols and reports, and push continuous improvement across sites, supporting Singapore-related operations and complex projects in a highly regulated biopharma environment.