Clinical Supply Chain Process and Compliance

**Title**:
Clinical Supply Chain Process and Compliance Project Manager H/F

**Company**:
Ipsen PharmSciences SAS

**Main responsibilities / job expectations**

**Process management responsibilities**
- Maintain a continued focus on process simplification and optimization and consistently explore ways of continuously improving the way the clinical supply chain of clinical trials is set up
- In collaboration with the **Clinical Supply Chain Project Managers** / **Leads**, develop, implement and maintain robust and efficient processes / ways of working related to GCSM and which includes:

- Set up of the supply chain related to clinical trials, from clinical labelling / IMP kit design up to the distribution to clinical sites
- Integration of new assets and / or new companies
- Develop the GCSM tool kit that supports efficient ways of working. This includes but is not limited to standards study planning and associated deliverables, checklists, risk assessments
- Translate the defined processes / ways of working in clear and synthetic quality documentation
- Organize workshop sessions to facilitate harmonization of ways of working / processes with the different **TA groups** as well as the **CDMO management team** to define adequate and efficient processes

**Compliance management responsibilities**
- Represent GCSM within Quality Management Systems meetings and ensure seamless alignment with transversal processes
- Execute the Change Control Management process
- Monitor and prepare summary metrics reports for GCSM-LT covering:

- Establish analysis and trending of quality events related to GCSM to help identify systemic issues, support recommendations for remediation and lessons learned
- Establish quality metrics and trend analysis from audit and inspection reports affecting GCSM performance
- Ensure the on-time closure of CAPA (deviations, audits and Inspections)
- Define and maintain training / onboarding programs and associated metrics:

- Define and maintain roles-based training plan for GCSM
- Develop, or participate in the development of, training tools and organizes initial and continuous training of in-house GCSM team members for a smooth integration into Ipsen processes & ways of working
- Work in close collaboration with the **Pharm Dev QMS** team on the above responsibilities

**Continuous improvement responsibilities**
- 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 to guarantee the method.
- Collaborate and align with other groups outside Pharm Dev such as **Global R&D Quality** and **Clinical Development organization**

**QEEHS Responsibilities 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**:
**Knowledge, abilities & experience**

Education / Certifications:

- Pharmacist, engineer or university graduate (BAC+5), degree in science or equivalent

**Experience**:

- Minimum 5 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure

Languages:

- Proficient in French and English

**Key Technical Competencies Required**
- Experience and knowledge on handling large and complex clinical trials (preferred)
- Excellent communication skills / networking
- Experience in project management
- Team player with ability to work in a matrix environment
- Strong organizational skills

**#LI-Hybrid