Lay Toh

• Currently leads a Quality Team (combined QA and QC) of about 50 personnel overseeing full spectrum of Quality Assurance, Quality Control, Compliance & Audit, Validation and Regulatory activities to start up the green field facility. • Setting the quality and compliance expectation for the various site functional teams to set up the green field facility and the quality management system, meeting the site objectives. • Sponsoring the site psychological safety program, encouraging the speaking up and resolution of unhealthy norms, leading to continuous improvement of processes and working environment.

• Led a team of 12 quality personnel overseeing full spectrum of Quality Assurance, Compliance & Audit, Validation and Regulatory activities. • Led the site through the first regulatory audit (by the Health Sciences Authority of Singapore) 2 months into the position, with no major concern of site quality system and processes highlighted. • Was preparing to move the site into a contract development and manufacturing organization (CDMO) in the next 1-3 years for early to late phase clinical products and commercial products, from the initial focus on only commercial manufacture. • One of the leads that led the site through the site operation cessation program, responsible for the quality compliance and regulatory aspects in winding down the site operations.

• Led an extended team of 34 quality personnel overseeing full spectrum of Quality Assurance, Quality Control, Compliance & Audit, Validation and Regulatory activities. • Led the site through regulatory (including HSA, USFDA, French ANSM, Japan PMDA etc), corporate and customer audits over 7 years, with no major concern of site quality system and processes highlighted. • Led the various site functional teams to meet the site objectives supported by a strong quality and compliance foundation. Key initiatives include the pushed for paperless solutions and laboratory automation, driving improvement on equipment reliability, and reduction in deviation and laboratory investigation rates. • Co-lead the site cultural program, encouraging the speaking up and resolution of unhealthy norm.

• Led the GSK Jurong analytical laboratory team with a staff strength of 51 from Jul11, with no prior experience in analytical testing, laboratory operations and management. Assumed the management of GSK Quality Road laboratory with an additional staff strength of 17 from Aug-13. • The position also requires a close working relationship with senior members of other site functional teams, in order to ensure that the laboratory operations was seamlessly integrated with the other operational functions of the site. • Led the laboratory team to deliver extensive analytical development and technology transfer programs, and regulatory audits from USFDA, ANVISA, PMDA, COFEPRIS, KFDA, HSA etc.

• 11 months experience as the site Regulatory Conformance Lead, leading a regulatory team of 3 members in the provision of regulatory service to internal / external customers such that the regulatory compliance of site business activities was maintained, and to provide seamless regulatory support to the lean New Product Introduction (NPI) quality initiatives to expedite the regulatory approval. • More than two years experience as a Senior Quality Officer, providing operational quality support for the Value Stream manufacturing, which included managing the deviation investigations, planned changes, batch release and process performance/compliance adherence metrics or information analysis such as annual product reviews. • Led internal audits as one of the site’s lead internal auditors.

• 2 years part-time employment (Aug-2006 to Jul-2008) with the Corporate Planning Office (CPO) while pursuing a full-time Masters of Science (Industrial Chemistry) program. Job responsibilities with CPO include the drafting of health product related regulation/policies, and reviewing the regulatory and operational processes within the organization. • Six years (Aug-2020 to Aug-2026) as an appointed lead GMP Auditor. Job responsibilities included audit and licensing of manufacturers (both local and overseas), distributors and retailers of health products and APIs, drafting regulation/policy, reviewing and refining the regulatory operational processes and training new GMP auditors.