Commercial Quality Senior Executive

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J&J IM is recruiting for a Commercial Quality Senior Executive reporting to the Commercial Quality Head and to be based in Cairo Egypt.

Role responsibilities

Oversight monitoring and improvement of Gulf Cluster quality/compliance metrics extending support to KSA Organization when required.

Partner proactively with commercial and functional stakeholders to ensure quality aspects of new launches delisting/divestures and Commercial Quality initiatives are aligned with strategic business direction.

Identify and sponsor local initiatives/projects to increase compliance reduce cost of non-quality/non-conformance and leverage cross-functional/cross-sector opportunities for J&J.

Trigger lead and/or coordinate local regional or global escalations recalls and communications with Health Authorities regarding product quality safety and/or compliance issues including serious quality issues and product supply interruption; support KSA Organization as needed.

Leading the local Quality System Management Review: Report to the Management Board of Gulf Cluster the performance of the QMS and the adequacy of the quality resources extending support KSA Organization when required

Lead/coordinate auditing inspections and external inspections for Gulf Cluster ensuring the commercial quality systems are in a constant state of readiness for planned/ad hoc audits or inspections; support KSA Organization as required. Quality Systems:

Ensure compliance with minimum requirements for lifecycle management of GxP documents/records provision of appropriate training for all job functions with GxP responsibilities (maintain the training matrix) and effective change control systems that are followed and closed on time.

Monitor Quality System performance versus local GxP CQM and J&J requirements using pertinent business/compliance metrics and goals and drive continuous improvement through periodic internal audits deviation management CAPA management and performance reviews.

Timely notify and engage LOC Quality Head SLT Commercial Quality and other affected stakeholders on substantive concerns (product quality safety and/or compliance) per CQM escalation procedures and ensure activities comply with requirements applicable to controlled substances.

Ensure activities are carried out in compliance with the specific requirements applicable to controlled substances.

Ensure suppliers and distributors (mainly for Gulf Cluster) are appropriately managed qualified and governed by required agreements that are reviewed/updated as needed; support EMEA centralized audits on suppliers and distributors when required and support KSA local team as needed.

Maintain a robust system to ensure product transportation storage receipt assessment and market release are performed per J&J requirements including proper assessment/communication of transportation temperature excursions and issuance of quality records for investigation/assessment; implement a robust process to receive and evaluate returned goods before rejecting or re-issuing.

Plan and assure regular internal audits of applicable GxP practices within the Local Operating Company and ensure product and AE complaints are efficiently managed in collaboration with relevant partners (e.g. Health Authorities LSO manufacturing plant QA logistics and other supporting functions).

Escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours with QE backup in every case of absence).

Support Gulf Cluster (and KSA Organization management team as needed) in new product introduction and all product portfolio lifecycle management processes and proactively work on improving the quality systems.

Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP including any legislation/guidelines relating to controlled substances.

Requirements

A background of working in pharmaceutical biotechnology industries with a substantial experience of either quality assurance or process methodologies. At least 5 years experience required.

Fluent knowledge of Arabic and English.

Knowledge of GMP GDP regulations and understanding of the importance of this area to the function.

Continues development into current local and EMEA regulations guidelines and industry quality standards.

Excellent interpersonal collaboration networking and communication skills self-motivated clear thinker.

Relevant university degree or business experience and qualifications in areas applying process methodologies.

Capable of analytical thinking and capable of summarizing the key elements.

Ability to leverage across both clusters.

Computer literate with good knowledge of the quality systems

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