Associate Clinical Supply Manager

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Responsibilities:

- Manage 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.

- Support continuous process optimization of local packaging by collaborating with external vendors and internal stakeholders (e.g., CDSM, PDQA) to improve efficiency and shorten turnaround timeline.

- Manage China IP supply kickoff meeting process by coordinating with cross-functional teams (e.g., CDSM, China / global clinical operation teams), ensuring timely alignment and IP readiness for study start-up.

- Manage China IP import in collaboration with cross-functional teams including CDSM, China GTC, China operation teams, ensuring timely delivery to support local trials.

- 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.

- Perform other duties assigned by line manager.

Qualifications

Qualifications:

- Bachelor’s Degree or above with at least 6 years of experience in pharmaceutical R&D industry, including at least 4 years in clinical supply chain, CMC or clinical operation related roles.

- High degree of flexibility and a strong aptitude for identifying innovative approaches to decision-making and problem-solving. Must proactively and effectively recognize, quantify, and mitigate potential risks.

- 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.

- Ability to work independently, with a strong team-oriented mindset and collaborative spirit.

- Strong ownership, proactive mindset, and effective execution capability.

- Good presentation and communication skills, with the ability to clearly articulate ideas and effectively engage with cross-functional stakeholders.

- Knowledge of GMP, GCP, GTC, etc. on clinical supply operations in China.

- Experience working with contract pharmaceutical organizations in China.

- Fluent in spoken and written Chinese and English.

Additional Information

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. 

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