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Job Description

OBJECTIVE

This role is to support troubleshooting for local registration testing and import testing, and to ensure consistent interpretation of Chinese Pharmacopoeia (ChP) & other testing requirements across the global network. 

ACCOUNTABILITIES

• Act as am analytical leader and expert to provide technical support to facilitate “accelerate product submission and launch” GQ China’s goal for Chinese market.
• Responsible for multiple project management, setting objectives, and prioritizing activities based on business requirements. Determining budget requirements to meet organizational goals and balancing resources to ensure that business needs are met.
• Support analytical troubleshooting efforts for local contract testing, registration testing and import testing.
• Support global network to align understanding of, and consistent interpretation of ChP and local testing requirements.
• Build network with local industry SMEs and government testing laboratories.
• Establish close working relationship with Global/OpU Analytical Sciences SMEs.
• Take ownership of analytical issues and drive closure quickly, correctly, and permanently for launch and commercial products.
• Support GQ function/OpU analytical method life cycle management (LCM) strategy and process tailored to launch and commercial products.
• Liaise and support GQ function/OpU AS SMEs in investigating and resolving complex analytical troubleshooting, quality incidents, complaints, deviations and investigations.
• Provide technical support on China specific documents for NDA submissions, identify and address technical gaps between ChP methods and internal methods.
• Create and enhance collaborative and trusting relationships internally and externally. Works closely with counterparts/stakeholders in GQ function/OpU, Pharm Science and GMSci establishing effective communication.
• Provide regulatory support for analytical methods and related aspects, which includes contribution to analytical submission content strategy and analytical content review.
• Support China launch and commercial products
  • Interface with key partners include RA, RACMC, supply chain, PDT, OpU Analytical Science, and launch excellence.
  • Provide analytical technical oversight for launch and commercial products
  • Collaborate with GQ functions/OpU AS to drive solutions for analytical issues in China and support quick closure
  • Serve as in-house analytical/technical expert for troubleshooting and investigating analytical issues
  • Develop and implement risk mitigation plans proactively for analytical test methods associated with registration and commercial testing.
  • Learn, enhance, and manage technical analytical knowledge to sustainably support launch and commercial products. Understand and interpret data from various sources to develop a local technical analytical knowledge database.

Qualifications & Skills:

Level of Education

• MSc/PhD degree in bioanalytical chemistry, pharmaceutical science or equivalent.

Working Experience in Relevant Field

• 5+ years for PhD (MS with 7+ years of experience may be considered equivalent) of working experience, including at least 2 years of increasing management responsibility combined with strong technical operations background in pharmaceutical/biotech industry, preferably in MNCs
• Experience in global pharmaceutical operations, supply chain management, Quality, project management and global environment
• Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
• Excellent communications and presentation skills – written and verbal; create and deliver summaries, and presentations as needs.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.
• Knowledge in analytical method lifecycle management and project management.

Professional Knowledge and Skills

• Solid knowledge in the development and validation of bioassay methods.
• Expertise in analytical method development, validation and transfers.
• Critical thinking and problem solving
• Strong communication skills in engaging local and global stakeholders (quality, manufacturing, supply chain, business, network)

• Fluent in Chinese and English, both written and spoken

Locations

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