Senior Manager, Clinical Supply Chain
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $128,000 - $173,000 per year
Job Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Manage drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical studies
- Develop and oversee supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste
- Represent Clinical Supply Chain to internal stakeholders and manage relationships with external supply partners
- Lead staff and provide leadership and guidance during process implementations.
- Create supply and inventory plans and develop production schedules for clinical trial materials
- Monitor schedule adherence of production schedules and make course corrections if needed
- Manage GMP inventory throughout the supply chain.
- Investigate exceptions to determine root causes, implement CAPAs and drive closure
- Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
- Support IRT user acceptance testing, develop IRT supply strategy, and oversee ongoing supply activities in the system.
Requirements
- Bachelor's degree with 7 years progressive experience in Supply Chain, preferably within the biotech, pharmaceutical, CRO industry
- or Master Degree in Business Administration, Operations Management, or similar education required, with 5 years progressive experience in Supply Chain, preferably within the biotech, pharmaceutical, CRO industry
- Demonstrates knowledge of global clinical trials and the drug development process
- Experience in vendor oversight and managing external partnerships and relations
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP)
- Experience in deviation investigation and CAPA implementation
- Knowledge of IRT system setup and functionality and proficiency with Excel modeling
- Strong analytical, problem solving, and communication skills
- Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams
- Efficient in Microsoft Word, Excel, and Outlook.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
supply chain managementGMP inventory managementdeviation investigationCAPA implementationIRT system setupExcel modelinglabel developmentproduction schedulingclinical trial materials managementrisk management
Soft skills
leadershipcommunicationanalytical skillsproblem solvingcollaborationteamworkrelationship managementprocess implementationcross-functional teamworkmulticultural team skills