Regional Manager - Due Diligence and Validation Quality

As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose level.

Responsibilities

• The Regional Manager - Due Diligence and Validation QA - primary responsibilities will include Due Diligence QA
• Primary Quality interface for new contract manufacturing site approvals within APAC Region.
• Primary Quality Lead for all APAC product acquisition, company acquisition due diligence activities, in-licensing deals and distribution deals.
• Validation QA
• Responsible for the development of the Abbott regional validation framework for all Sterile and Non-Sterile manufacturing sites, this includes standardization and streamlining of validation approaches across the business computer system validations, Analytical Methods Validation, facilities, utilities, equipment, cleaning and manufacturing processes.
• This role provides leadership in finalizing and maintaining the Abbott regional validation strategy and harmonizing the sites' Validation Master Plans. Collaborates with Operations, other Quality team, Engineering, M&ST, R&D and Regulatory Affairs
• Responsible to establish and implement due diligence processes and procedures for the application into the quality & technical assessment of medicinal products, medical devices & consumer health products for new business opportunities.
• Responsible for managing on site GMP audit program for contract manufacturing sites and contract laboratories for APAC region, including all related activities for initial selection, due diligence, and ongoing surveillance, in accordance to regulatory and business requirements.
• Primary QA contact in all business development and L&A initiatives.
• Primary QA contact for contract drafting / negotiations for all new deals, contracts agreements and quality technical agreements (QTAs).
• Transition of TPM to TPM & Suppliers QA and Technology Transfer QA.

Requirements

• Min Bachelor's Degree in Life Sciences
• 10-15 years of pharmaceutical experience with minimum 5 years’ validation experience.
• Knowledge and experience with Sterile and Nonsterile process is a must.