Manager of Clinical Supply Chain Operations

2 weeks ago

Cambridge Massachusetts, United States Biogen Full time
Position Overview

The Global Clinical Supply Chain (GCSC) is seeking a skilled Manager of Clinical Supply Chain Operations to ensure a high standard of compliance and efficiency in GCSC's processes. The primary objective of GCSC is to provide essential medications globally to all participants in Biogen's Clinical Studies. This role encompasses responsibilities related to production planning and the execution of distribution for all Clinical Trial materials.

Key Responsibilities:

Quality Assurance:
Serve as the project lead for any quality-related initiatives within GCSC.

Facilitate audits and inspections involving GCSC, originating from both Technical Operations and Clinical Operations.

Become the expert in GCSC regarding quality systems, understanding the organizational drivers and objectives behind these systems.

Collaborate closely with the Clinical Operations Quality team to establish clear roles and responsibilities, ensuring smooth quality management across functions.

Oversee and drive complex corrective and preventive actions (CAPAs) and performance evaluations (PEs) to completion within R&D and Technical Operations systems.

Leadership in Product Lifecycle Management (PLM):

Act as a super user of the PLM system, which is essential for change control management, item creation, and other product lifecycle activities.

Provide guidance across GCSC to promote excellence in PLM system usage through training and support.

Manage quality metrics for GCSC, including the collection and dissemination of change control metrics.

Engage actively with the PLM user community, representing GCSC and advocating for its challenges and opportunities.

Knowledge and Training Management:

Coordinate and deliver training on quality and systems to GCSC and relevant stakeholders.

Maintain training curricula aligned with job descriptions.

Oversee the departmental SharePoint site to enhance information accessibility.

Keep a catalog of procedures utilized by GCSC to facilitate onboarding, operations, and audit readiness.

Corporate Connectivity Management:

Stay informed about Regulatory Intelligence insights and assess their relevance for GCSC.

Manage corporate requirements such as Business Continuity Plans and Business Impact Assessments.

Oversee security alerts for GCSC and direct relevant supply alerts to appropriate teams.

Candidate Profile

The ideal candidate will possess the ability to influence effectively within a matrixed organization without direct people management. Drawing from past experiences, they should be capable of developing innovative solutions to complex challenges. Performance in this role will significantly impact functional efficiency, compliance, audit outcomes, and overall business continuity.

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