Clinical Supply Chain CDMO Project Manager

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* Title:

** Clinical Supply Chain CDMO Project Manager
** Company:
** Ipsen Biopharmaceuticals Inc.
** About Ipsen:
** Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.

We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at and follow our latest news on and .
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* Job Description:

**** WHAT -*
* ** Summary & Purpose of the Position
**** As part of the Global Clinical Supply Management organization, the Clinical Supply Chain CDMO Project Manager is responsible for managing outsourced clinical packaging and distribution operations in compliance with Good Manufacturing Practices. The role supports the Clinical Supply Chain CDMO Management Lead in establishing and maintaining effective collaborations with external vendors to ensure the supply of materials required for the conduct of clinical studies.
**** The Clinical Supply Chain CDMO Project Manager executes responsibilities in accordance with current internal and external regulatory guidance and company processes, while meeting agreed timelines, resource constraints, and budget requirements. The role also contributes to continuous improvement activities and knowledge management related to the development of new chemical entities and the lifecycle management of products within development.
**** WHAT -*
* ** Main Responsibilities & Technical Competencies
**** Clinical packaging and distribution responsibilities:
*** According to the clinical forecasts / timelines, and in collaboration with CDMOs and Clinical Supply Chain Therapeutic Area groups, define the planning for packaging, labeling and distribution for studies outsourced and ensure the on-time supply to patients with no stock outs of IMPs
* Support in CDMOs selection and maintenance
* Assess the impact of changes in clinical studies on planning and propose mitigation plans accordingly
* Coordinate and lead meetings with CDMOs in charge of clinical packaging and distribution
* Monitor CDMOs performance through KPIs
* In collaboration with the Suppliers Quality Assurance department, set up and maintain of Quality Technical Agreements
* Ensure the on-time availability of the documents required for his/her activities, i.e. instructions, batch records, reports, specifications...
* In collaboration with the Operational Quality Assurance team, ensure the review of the batch records and instructions of clinical IMPs
* Manage quality events (deviations, change controls) in line with defined KPIs
* Ensure activities are performed as per the agreed budget and with respect to the procurement processes: request quotes, launch commitment requests and place purchase orders
* Ensure vendors are paid in due time and based on diligent invoices review
* Develop/maintain a network of efficient CDMOs / vendors to ensure his / her activities
* Implement and maintain robust collaboration with vendors to procure comedications and / or comparators
* Implement and maintain robust collaboration with vendors to supply materials required to support clinical packaging and distribution activities when performed internally (booklet labels, packaging materials, etc.)
* Monitor clinical kits destruction process under CDMOs responsibility when needed
* Present the results and progress of projects under his/her responsibility at internal technical meetings
* Ensure regulatory surveillance related to his / her activities (guidelines, GMP, Annex 13, Annex
1)
* Develop and optimize the team’s interfaces within GCSM as well as with the Operational Quality Assurance and Drug Product Management team
** Continuous Improvement:
*** Support the Process and Compliance Project Manager while defining and / or adjusting GCSM processes / ways of working and providing effective as well as continuous feedback.
* Organize and actively participate in lessons learned exercises when needed.
* Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development.
* Be a promoter of continuous improvement processes and guarantee the method.
** QEEHS Responsibilities:
*** Respect the Good Practices applicable (BPF, BPD, ...), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
** CSR Responsibilities:
*** Apply and…