Clinical Supply Operations Manager

Job Description

About This Role

The Global Clinical Supply Chain (GCSC) is looking to hire a Clinical Supply Operations Manager to assure a high level of compliance and effectiveness for GCSCs operations. GCSC’s goal is to deliver medicines across the world to all patients enrolled in Biogen’s Clinical Studies. The function’s responsibilities include the production planning and distribution execution for all of Biogen’s Clinical Trial materials. This is where this role comes in – the team needs expertise and leadership to manage Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.

This person will build positive connectivity with the corporate Quality teams and programs and assure effective use of Biogen’s change management system PLM. This role will lead corporate initiatives on behalf of GCSC, such as Business Continuity planning and Business Impact Assessments. Finally, the role will be responsible for knowledge and training management in GCSC.

This is a hybrid role that can be based either at our office in RTP, NC or Cambridge, MA.

What You’ll Do:

Quality Management:

• Act as GCSCs project lead for any quality-related project or initiative.
• Facilitate all audits and inspections that include GCSC, originating from both PO&T (Tech Ops) and Clinical Operations (R&D)
• Become the fully trained go-to expert in GCSC for quality systems and understand the organizations, drivers and goals behind these systems.
• Closely collaborate with the Clinical Operations Quality team to build clear R&Rs and facilitate seamless quality management between the functions.
• Owns and executes complex, multi-program or orphaned CAPAs and PEs within R&D and PO&T systems and drives them to conclusion.

PLM Leadership:

• Super user of the PLM system which is used for change control management, item creation, BOM creation and other product lifecycle management activities.
• Provide leadership across GCSC to drive PLM system usage excellence via training, support and if needed escalation with other functions.
• Manage quality metrics for GCSC including change control metrics collection and distribution. This also includes gaining command of quality metrics used in the broader organization, assess them for impact and relevancy to GCSC and apply them as appropriate.
• Become an active member of the PLM user community and act as voice of GCSC. In this context, collect and organize into themes the challenges and opportunities that the GCSC organization sees, and advocate for them.

Knowledge and training management:

• Coordinate and deliver Quality and system training to GCSC and stakeholders.
• Manage training curricula in alignment with job descriptions.
• Own departmental SharePoint site BRAIN and improve accessibility of information and insights.
• Maintain a catalog of procedures owned or used by GCSC to streamline onboarding, operations and audit readiness

Corporate connectivity management:

• Stay connected to Regulatory Intelligence insights and triage them for GCSC.
• Manage-in corporate requirements such as Business Continuity Plans and Business Impact Assessments.
• Manage-in security alerts for GCSC and direct supply-relevant alerts to relevant groups.

Who You Are

Without direct people management, you should be able to effortlessly influence while working collaboratively in a matrixed organization. You should be able to draw from past experiences to develop solutions to complex problems that require a degree on ingenuity, creativity and innovativeness. Performance will directly reflect into functional efficiency and may impact compliance and audit findings, as well as business continuity.

Qualifications

Required Skills

• Bachelor’s degree in related field with a minimum of 5-7 years in a CMP/GCP environment, including managing GMP/GCP activities in enterprise systems.
• Experience in pharmaceutical supply chain environments.
• Experience with Quality Management Systems such as Oracle PLM, or similar system.
• Broad knowledge of quality operations, from theory to practice and from End-to-End process view to tactical system activities in PLM.
• Excellent written and verbal communication skills in the English language, project management skills as well as stakeholder management skills.

Preferred Skills

• Clinical Supply Chain experience
• Familiar with continuous improvement and Lean Six Sigma/ DMAIC
• Experience with ERPs such as Oracle EBS or similar system.

Additional Inform