GRA Compliance Manager

Title:

GRA Compliance Manager

Company:

Ipsen Innovation (SAS)

Job Description:

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

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.