Gra Compliance Manager

il y a 2 semaines

Les Ulis, France Ipsen Innovation (SAS) Temps plein

**As Regulatory Compliance Manager within the GRA Excellence organization and under the Regulatory Compliance Senior Manager**:

- Oversee all compliance aspects related to Global Regulatory Affairs activities in accordance with regulatory requirements and IPSEN standards.
- Share compliance outcomes with the Global Regulatory Affairs community and relevant external stakeholders.
- Promote a culture of continuous improvement within the GRA department, positioning compliance as a driver of business value.
- Support in GRA business activities as needed
- Balance the compliance strategic objectives with the regulatory operational needs

**Main tasks**

**Manage the GRA Compliance’s Monitoring processes**
- Ensure the execution of monthly process, analysis of results and actions plan follow-up.
- Prepare the communication and reporting documents related to the monthly process results and carry out trend analysis
- Communicate and liaise with our key stakeholders to promote education, understanding and adherence from End-Users and to ensure integrity of the results
- Ensure the development of the appropriate process for new regulatory requirements.

**Manage Deviations & CAPAs management for GRA in Quality systems**
- Ensure the central tracking of Deviations and CAPAs to enable their appropriate follow-up
- Drive periodic meetings with Global Quality for on-going deviations and CAPA review and support stakeholders and liaise with them to propose improvements
- Provide support in terms of quality expertise and skills to GRA team for deviation management into eQMS

**Support the Regulatory Coordination during audits and inspections**
- Ensure the delivery of the appropriate Regulatory support during the preparation, conduct and follow-up of audits and inspections as required
- Lead and ensure the preparation of audits and inspections by coordinating actions with appropriate stakeholders
- Lead and ensure the management of audits and inspections requests and reports on a timely manner
- Ensure communication to the identified stakeholders to meet timelines, to promote adherence and reactivity and to continuously improve

**Manage Training Compliance requirements**
- Maintain relevant quality documentation to support the entire GRA training management process
- Maintain the annual training tracker to capture training plan and attendance compliance
- Centralization and maintenance of training files (e.g. CV, Job descriptions, external training files)
- Support third party training management

**Participate in the development of the GRA processes**
- Support the authoring, review and approval of GRA quality documentation
- Liaise with stakeholders to propose improvements within the framework of performance measurement results and Deviations & CAPAs follow-up

**Experience / Qualifications**

**Ideal**:

- At least 5 years professional experience, including 3 years’ experience in Regulatory Affairs (at global or local level) or Quality
- Experience in monitoring regulatory compliance in Pharmaceutical Industry

**Minimum**
- Advanced degree in life sciences (e.g. pharmacist, healthcare engineer) or equivalent relevant professional experience
- Experience working in matrix organizations
- Shows a constant focus on process improvement. Challenges and questions ways of working to seek improved process.
- Good organizational skills, interpersonal and negotiation skills
- Good written and oral communication skills
- English fluent if not mother tongue

**Key Technical Competencies Required**
- Key Required Technical Competencies:

- Excellent knowledge of the Microsoft Office Pack

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