Quality Manager Commercial Operations Meam
Dubai, United Arab Emirates
Job Description
Title: Quality Manager Commercial Operations MEAM Company: Ipsen Pharma (SAS) : Scope Department: Global Quality
- Position title: Quality Manager
- Reports to: Quality Systems Commercial Operations Director, Commercial Operations
- Based in DUBAI
- 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\xe2\x80\x99s.
- To ensure that quality and compliance are fully and efficiently integrated as per company\xe2\x80\x99s 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.
- 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.
- 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.
- Encourage best practices (\xe2\x80\x9cQuality beyond compliance\xe2\x80\x9d), specifically from a continuous improvement perspective.
- Maintain structured customers/stakeholder\xe2\x80\x99s communication between local Ipsen sites/functions and the corporate ones to improve integration.
- 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.
- 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.
- Ideal: Life sciences Master degree (pharmacy, chemistry, microbiology).
- Minimum: Life sciences degree with significant, appropriate experience.
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Job Detail
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Job IdJD1489473
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDubai, United Arab Emirates
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EducationNot mentioned