Global Quality Operation Specialist

The Quality Operation Specialist will be in charge for the collaboration model internally with Affiliates / Representative offices and externally with Alliance Partners who are MAH on end market(s). In her/his capacity will monitor, prepare reports, and follow up, including timely tracking of activities agreed through Technical Quality Agreement to be fulfilled by BESINS HEALTHCARE and its subcontractors. She/he will provide support in managing and maintaining various QMS elements (e.g. CAPAs, Deviations, Change Controls, Documentation, Vendor Management activities) in compliance with regulation and corporate processes. This is a corporate cross functional role that will cover working in the global organisation. Accountability 1: Collaboration with AFFILIATES / Representative offices (internal stakeholders)

Expected result:

Organize regular meetings with the stakeholders: approx. 12 BH local offices in scope Prepare standard Agenda as per Technical Quality Agreement in place Created and disseminate meeting minutes with the stakeholder. Register activities in tracker and properly prioritize it. In case of urgency or high risk communication coming from Health Agency, elevate it immediately. Perform review and regular follow up informing stakeholder on status of pending tasks Coordinate all requests with manufacturing site(s) and Supply Chain team. Disseminate received information / document(s) in agile way avoiding delays which can cause shortage on the market or regulatory consequences for the stakeholder Measure the time needed to obtain information and ask proactively improving process Prepare the Monthly / Quarterly Report with corrective and preventive actions (CAPA) if any and including risk of occurrence within an agreed time frame. Disseminate knowledge on processes / situation with BH Affiliates, distributors and BH partners. As required, participate in improvement initiatives. Accountability 2: Collaboration with ALLIANCE Partners (external stakeholders)

Expected result:

Organize regular meetings with the stakeholders (i.e. top 10 alliance partnership in scope) Prepare standard Agenda as per Technical Quality Agreement in place Regularly review meeting minutes disseminated by alliance partners Register activities in tracker and properly prioritize it. In case of urgency or high risk communication coming from Health Agency, elevate it immediately. Perform review and regular follow up informing stakeholder on status of pending tasks Coordinate all request with manufacturing site(s) and Supply Chain team. Disseminate received information / document(s) in agile way avoiding delays which can cause shortage on the market or regulatory consequences for the stakeholder Measure the time needed to obtain information and ask proactively improving process Prepare the Monthly / Quarterly Report with corrective and preventive actions (CAPA) if any and including risk of occurrence within an agreed time frame. Disseminate knowledge on processes / situation with BH Affiliates, distributors and BH partners. As required, participate in improvement initiatives. Accountability 3: Compliance oversight

Expected result:

Any request / complaint coming from affiliate / partner properly record in ENNOV system (if not organize differently). Based on RISK categorize it and in case critical / major defect elevate as per reporting line to senior management If requested prepare communication referring properly to QMS and provide manager concurrence. In case of communication with Health Agency, manage compliant escalation process to Global Quality Head / BH RP as per QMS requirements. To maintain compliance oversight, organize meeting(s) / training(s) to timely disseminate stakeholder expectations to all BH parties including contract party. Prepare and timely communicate applicable KPIs. Accountability 4: Risk Management

Expected result:

Identify potential risk in the process of management internal / external customers (stakeholders) and develop mitigation plan to reduce and/or control identify risk. Escalate major and critical risks to the senior management Qualifications

University degree in science, engineering or pharmaceutical related field. Master’s degree is a prerequisite. A minimum of 7+ years of experience in pharmaceutical or biotechnology industry, on position related to quality, regulatory, manufacturing and / or development Understanding of GxPs, quality systems and regulations (EU, FDA and knowledge of Canada or other geographies’ regulations is a plus). Proficient in Microsoft office. Working experience in eQMS is plus. Ability to work in an international matrix environment. Fluent English skills required, French or other languages will be a plus

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