Clinical Supply Manager
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Shanghai, SH
- Research & Development
- Full-time
AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
- Manage secondary packaging jobs in China TPMs in partnership with support functions including CDSM and global PDQA, ensuring requests are completed within required timeline and in compliant with GMP & AbbVie procedures.
- Manage and improve China site shipment by working with cross-functional teams, including CDSM, CSM, and Regulatory, to reduce product waste and ensure efficient & smooth site delivery.
- Establish and maintain China site shipment requirements database by working with CSM and third-party vendors.
- Support China Health Authority 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, AbbVie 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.
- Bachelor’s Degree or above with at least 5 years of experience in the clinical supply chain, CMC or clinical operation related roles. Experience within the pharmaceutical industry may also be considered.
- 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.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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