Quality Systems Commercial Operations Coordinator H/F
22 septembre 2017 CDI Boulogne-Billancourt - 92
Management : Non renseigné
Référence : CA/QSCOC/B/2024753
Purpose of the position :
- To foster quality culture within the Commercial Operations and drive quality initiatives with providing a contact point for quality matters.
- Responsible for implementing & maintaining relevant QMS to assure the Commercial Operations groups are fully compliant and efficient with Global GxP's.
- To ensure that quality and compliance are fully and efficiently integrated as per company's GxP Quality Systems. The primary focus relates to one area (e.g. encompasses local Distribution, Medical Affairs, Safety Management and Regulatory Affairs activities) but responsibilities may expand into other Commercial Operations as needed.
- In charge of support for the Affiliates, Representative Offices, Business Units and Alliance Management to adequately handle quality issues and to provide governance on quality matters. Some support may BE required for other business units and franchises as well.
- Act as the Primary Point of Contact in Quality as liaison between Global Quality and functional entities for a dedicated area.
Main responsibilities and tasks :
RESPONSIBILITIES IN THE ABOVE ROLE ARE NOT LIMITED TO THOSE DESCRIBED AND MAY EVOLVE OR CHANGE FROM TIME TO TIME.
Deploy QMS across Commercial Operations groups efficiently :
- In charge of the definition of QMS for Commercial Operations in collaboration with other functions having GxP related activities (e.g. Medical Affairs, Safety Management, Regulatory Affairs, Global Supply Chain).
- Responsible for the definition of Ipsen QMS and related documents (e.g. Global Quality System, Quality Technical Agreement (QTA)) in collaboration with Global Quality, acting as business representative.
- Contribute to the definition of roadmap for the deployment and/or consolidation of QMS elements within Commercial Operations, and drive accordingly.
- Follow local QMS deployment working with both global and local, Affiliates, Representative Offices, Business Units and Alliance Management.
- As Document Manager guide process owners, authors, and users regarding the quality document review process (e.g. use of Easidoc) including training strategy.
Ensure GxP compliance :
- Drive remediation plans when a product quality or GxP process issue is identified.
- In charge of supporting inspection and audit (i.e. inspection readiness program & CAPAs definition/completion).
- Strengthen the risk management culture and support the maintenance of the Global Quality risk register.
- Ensure comprehensive training program covering all GxP activities is in place and support training initiatives as needed.
- Responsible for the implementation of Quality Management Reviews for a dedicated area.
Foster Quality culture :
- Encourage best practices (“Quality beyond compliance”, specifically from a continuous improvement perspective).
- Maintain structured customers/stakeholder's communication between local Ipsen sites/functions and the corporate ones to improve integration.
Support sites & business units :
- Focus on proactive crisis prevention and efficiency support crisis management (QSEB) and CAPA follow-up when needed.
- Facilitate troubleshooting (e.g. analytical transfer, compliance issues) with sites/functions/business units. Assure appropriate change, deviation and CAPAs are written and completed on time. Escalate as needed.
- Support/trigger local initiatives on continuous quality improvement.
- Product complaint manager for Alliance partners.
- Create, negotiate and follow QTAs for Quality Commercial Operations.
- In charge of APQRs communication to MAH on a timely manner.
- Responsible for supplier's oversight in collaboration with Global Quality and business.
- Minimum 20% of the time, worldwide.
- No direct or functional reports.
Experience / Qualifications :
- Ideal : 2 years in international pharmaceutical quality management, practical GxP experiences as well as working in matrix organization is an asset so is working in Commercial Operations environment.
- Minimum : 2 years relevant experience in pharmaceutical quality management environment.
- Ideal : Life sciences Master degree (pharmacy, chemistry, biology).
- Minimum : Life sciences degree with significant, appropriate experience.
- Thorough knowledge and understanding of Health Authorities requirements and industry standards related to GxP.
- Experience in QMS design and content.
- Experience with major Health Authority inspections and audits.
- Fluent in French and English, both oral and written. Additional language appreciated.
- Ability to work in cross-functional environment (matrix organization).
- Excellent written, verbal and interpersonal communications skills ; highly organized.
- Ability to work to short deadlines and react quickly to change situations.
- Strong analytical and problem solving skills.
Rémunération : Non précisé.
Soyez l'un des 10 premiers candidats.