Department: Development Team

Job Title: Clinical Supply and Quality Assurance Specialist

Description:

The Clinical Supply Quality Specialist coordinates the packaging, labeling and distribution activities required to provide Investigational Product (IP) for clinical trials. This person coordinates and ensures delivery of drug compounds for clinical trials, procures bulk supplies from outside vendors as needed, oversees appropriate labeling and packaging issues, and facilitates the timely arrival of supplies at clinical investigative sites. The Clinical Supply Quality Specialist will assist with forecasting supply needs and recommending outsourcing opportunities to relevant governance units within the company.  Also, this person is responsible for Quality Assurance activities as applicable to IP.

• Define packaging, labeling and distribution strategy for investigational product
• Forecast supplies needed for country/region/protocol
• Coordinate, oversee and document activities related to packaging/labeling of IP (i.e. batch record production & review, scheduling production with vendor, etc.)
• Review and approve manufacturing batch records, validation plans, specifications and other GMP documentation
• Coordinate and document activities related to distribution of IP (to warehouse for storage, to country-specific depot for distribution to clinical sites, etc.)
• Serve as a project manager to ensure all regulatory and/or submission related deliverables are provided on time based on established project plans
• Identify activities or events that may critically affect the availability of IP and act on or relay that information to appropriate level of management
• Maintain current, accurate and complete IP study files (hard copy & electronic, as appropriate)
• Review IP shipment requests for accuracy and completeness prior to processing
• Assist in maintaining oversight of inventory of all filled-lots and labeled-lots (IP) from date of release through final reconciliation and closeout of trial
• Maintain oversight of the returns process (including stock recovery) to aid in documenting full reconciliation of IP
• Coordinate and document activities surrounding complaints, excursions, or deviations received from sites or vendors
• Present updates to management and project team leaders in a matrix product development team structure
• Write, review, and approve SOP’s and other related documentation
• Audit third party suppliers and internal systems
• Handle confidential information and perform duties in strict confidence
• Ability to multitask with varying priorities
• Other projects as assigned or requested