clinical Quality ManagerMICHAEL PAGE INTERNATIONAL RECRUITMENT (PHILIPPINES) INC.

Job Description
A billion dollar global pharmaceutical company
Lead 2 portfolios - BioPharma and Oncology
About Our Client
A global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.
Job Description
Responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.
Supports audits and inspections and is the main contact for auditors for the local team.
Planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions.
Keeps abreast of any business compliance issues and works in close collaboration with Regional Director, Clinical Quality SMM (RDCQ) and any key regional and global networks.
The Successful Applicant
Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
8-10 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance.
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
Good understanding of the drug development process and related GXP activities.
Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.
Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
Good ability to learn and to adapt to work with IT systems.
Ability to travel nationally and internationally as required.
What's on Offer
Onsite
Succession planning
Holistic scope
Competitive package
Contact
Eds Manuel
Quote job ref
JN-062023-6100529
Phone number
+63 [Protected Info]