IPSEN Hiring for Quality Manager Commercial Operations MEAM Job at Dubai Full Time

Title:

Quality Manager Commercial Operations MEAM

Company:

Ipsen Pharma (SAS)

Job Description:

Scope

Department: Global Quality

• Position title: Quality Manager
• Reports to: Quality Systems Commercial Operations Director, Commercial Operations
• Based in DUBAI

Purpose of position

• To foster quality culture within the Commercial Operations and to drive quality initiatives within IPSEN Commercial Operations Stakeholders providing a contact point for quality matters for one or more region.
• To implement & maintain 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 affiliates, rep offices, alliance partners but responsibilities may expand into other Commercial Operations as needed. (e.g. encompasses local Distribution, Medical Affairs, Safety Management and Regulatory Affairs activities)
• To support Commercial Operations Stakeholders (both global and local organizations) 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.

Main responsibilities and tasks

Ensure responsibilities regarding GxP related activities within Commercial Operations are duly fulfilled as per Quality RACI.

More specifically, key duties are:

Deploy QMS across Commercial Operations Groups efficiently

• Contribute to 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).
• Contribute to the definition of Ipsen QMS and related documents (e.g. GQS, e-quality systems URS), acting as Commercial Operations representative, where necessary.
• Define roadmap for the deployment and/or consolidation of QMS elements within commercial operations, and drive accordingly, where necessary.
• Work with both global and local Commercial Operations on QMS deployment, e.g. Quality Management Review SOPs writing and dissemination, where necessary.

Ensure GxP compliance

• Drive remediation plans when a product quality or GxP process issue is identified.
• Support inspection and audit management (i.e. inspection readiness program & CAPAs definition/completion).
• Strengthen the risk management culture and support the maintenance of the GQ risk register.
• Ensure comprehensive training program covering all GxP activities is in place and support training initiatives as needed.

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 efficiently support crisis management (QSEB) and CAPA follow-up when needed.
• Facilitate troubleshooting (e.g. complaints management, QTA negotiation, compliance issues) with sites/functions/business units. Assure appropriate CAPAs are written and completed on time.
• Support/trigger local initiatives on continuous quality improvement.

Travel: : Minimum 20% to 40% of the time, worldwide.

Experience:

• Ideal: 5 years in international pharmaceutical quality management, all practical GxP experiences as well as working in matrix organization is an asset so is working in Cial Operations environment.
• Minimum: 3 years relevant experience in pharmaceutical quality management environment.

Education:

• Ideal: Life sciences Master degree (pharmacy, chemistry, microbiology).
• Minimum: Life sciences degree with significant, appropriate experience.

Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.