Company Description
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, You Tube and Linked In.

Job Description
Purpose:
The Clinical Supply Manager will be responsible for managing key clinical supply chain activities for Abb Vie or Partner-sponsored phase I – IV clinical trials in China. This role requires project management skills, understanding of complex study designs, and the implementation of Global Clinical Drug Supply Management (CDSM) policies and procedures. The successful candidate will work independently with minimal oversight, collaborating with local and global teams.
Responsibilities:

• Manage secondary packaging jobs in China TPMs in partnership with support functions including CDSM, China RDQA and global PDQA, ensuring requests are completed within required timeline and in compliant with GMP & Abb Vie procedures.
• Manage and improve China site shipment process by working with cross-functional teams, including CDSM, CSM, and Regulatory, reducing product waste and ensuring efficient & smooth site delivery.
• Support China Health Authority (NMPA, CDE, local FDA) inspection for clinical supply related queries.
• Support local clinical supply Standard Operating Procedures (SOPs) or Work Instructions (WI) creation in partnership with CDSM, Regulatory, QMTC and QA.
• Ensure adherence to local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and quality standards in conducting clinical trial supply. Stay updated on new and evolving local regulations, guidelines, and policies.
• Establish and maintain relationships with global and local cross-functional teams, clinical sites, and dispensing & destruction depots to ensure reliable delivery/destruction of the IP.

Qualifications

• 
  Bachelor’s Degree in Life Science preferred with at least 2-5 years of experience in the Clinical Supply, CMC related roles.
• High degree of flexibility and a strong aptitude for identifying innovative approaches in decision-making and problem-solving. Must proactively and effectively recognize, quantify, and mitigate potential risks.
• Proven leadership skills in managing complex projects.
• Ability to think in multiple dimensions and balance priorities to ensure timely and budget-friendly supply delivery of the highest quality, while adhering to regulatory requirements.
• Strong communication skills, fluent in spoken and written Chinese and English.
• Knowledge of GMP, GCP, GTC, etc. on clinical supply operations in China.
• Experience working with contract pharmaceutical organizations in China

Additional Information
Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is Abb Vie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html