Senior Serialization Consultant

Job Title: Senior Serialization Consultant

Job Number: 32908

Location: Remote, 

Job Description

Converge is in search of a Senior Serialization Consultant / Practice Leader with a strong knowledge of DSCSA requirements to join our growing consulting practice serving the Life Sciences industry. The ideal candidate will have experience designing and implementing track and trace solutions, and experience integrating serialization and manufacturing business processes. The individual in this role will work closely with clients and project teams to ensure serialization solutions meet regulatory requirements and timelines.

Responsibilities

• Participation in consulting project teams to define client issues related to DSCSA and recommend approaches and solutions to address those issues.
• Assisting with the development of serialization related work plans, with responsibility for executing portions of the plan and monitoring/reporting progress to the plan.
• Supporting clients in determining serialization strategies, priorities, and business requirements.
• Supporting clients in obtaining (or developing) appropriate pre-requisites for serialization (labeler code, NDC, GS1 identifiers, etc)
• Executing client internal setup activities for design, system administration execution, system configuration and informal testing with CPO and 3PL.
• Supporting client-specific internal activities and decision making.
• Providing regular progress updates and communications, including escalation and resolution support for issues encountered.
• Supporting ongoing serialization management and operations.

Required Skills

• 10 + years’ experience in supply chain management in the biopharmaceutical industry associated with 5+ years of DSCSA and serialization experience
• Experience selecting and/or implementing serialization related solutions and practices
• Familiarity with the appropriate DSCSA regulatory environment and compliance is essential.
• Previous strategy, operations or consulting experience is desirable
• Relevant undergraduate degree, with MBA or other advanced degree, or equivalent experience