Date Posted: 03/18/2024

Hiring Organization: Rose International

Position Number: 460621

Job Title: Manager, Supply Chain

Job Location: Foster City, CA, USA, 94404

Work Model: Hybrid

Shift: Onsite 3 days per week

Employment Type: Temporary

Estimated Duration (In months): 7

Min Hourly Rate($): 50.00

Max Hourly Rate($): 65.00

Must Have Skills/Attributes: Clinical, Manufacturing, SOP, Supply Chain

Job Description

Manager, Supply Chain, is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for our global clinical trials. The Manager works collaboratively with other members of GCSC, PDM and DevOps staff to meet project deliverables, solve business problems and create competitive advantage.

This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide.

Required Years of Experience:

• 5-8 years progressive experience in Supply Chain within the biotech, pharmaceutical, industry

Required Degree or Certification:

• Bachelor or Master Degree in Business Administration, Operations Management, or similar education required

Required Skill Sets:

• Demonstrates knowledge of global clinical trials and the drug development process
• Knowledge of IRT system setup and functionality and proficiency with Excel modeling
• Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams

Preferred Experience/Skill Sets:

• Experience in deviation investigation and CAPA implementation
• Experience in vendor oversight and managing external partnerships and relations
• Strong analytical, problem solving, and communication skills

Qualifications:

• Excellent verbal, written, and interpersonal communication skills
• Strong computer and organizational skills
• Project management experience
• Able to anticipate client obstacles and difficulties and act upon this to meet goals
• Ability to write clear, concise, and error-free documents
• Ability to exercise judgment within defined procedures and policies to determine and take appropriate action
• Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13
• Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics
• Possess strong collaboration, influencing and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs
• Works well with ambiguity, can assess options quickly and efficiently and implement best option in alignment with our culture and expectations for clinical timelines

Supply Chain Manager Responsibilities:

• Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3, Managed Access)
• Leads end –to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs)
• Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP)
• Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence
• Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains
• Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement
• Actively participates in and supports continuous improvements programs, processes and systems
• Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain
• Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance
• Prepares and/or approves purchase orders and supports the budgeting process
• Examines functional issues from a broader organization perspective and supports day to day operation activities as needed

**Only those lawfully authorized to work in the designated country associated with the position will be considered.**

**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

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Job Types: Full-time, Temporary

Pay: $50.00 - $65.00 per hour

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Do you have experience in clinical supply chain experience?
• Are you able to go onsite at Foster City, CA 3 days a week?
• Are you authorized to work on Rose International’s W2 without sponsorship?

Education:

• Bachelor's (Required)

Experience:

• Supply Chain : 5 years (Required)

Ability to Commute:

• Foster City, CA 94404 (Required)

Work Location: In person