Regional Manager - Due Diligence and Validation Quality
Regional Manager - Due Diligence and Validation Quality
Posted on :
21-08-2025
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1 Vacancy
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Job Description
JOB DESCRIPTION:
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 were 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 includeDue 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 Bachelors 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.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
Singapore > Singapore : DUO Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Employment Type
Full-Time
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