Janssen Turkey – Senior Commercial Quality Specialist

• Implement the Quality System via transposition of the requirements of the Commercial Quality Manual (CQM) and J&J Quality Management System
• Prepare, update and approve LOC procedures in accordance with local GMP/GDP, CQM and J&J requirements
• Execute batch release to the market.Delegation of Responsbile Manager role, when needed
• Execute minimum requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity
• Ensure the provision of appropriate training for all job functions with GMP/GDP responsibilities
• Ensure appropriate internal and external change control systems are in place and are followed
• Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the CURVE
• Monitor quality system performance versus local GMP/GDP, CQM and J&J requirements via use of pertinent business and compliance metrics and goals
• Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews
• Notify and engage LOC Quality Head and Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in CQM

• Ensure an effective procedure and adequate system to handle product and PQC complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours, plus COMMERCIAL QUALITY HEAD backup in every case of absence)
• Ensure suppliers of any critical materials (all product related suppliers & services) are qualified and periodically audited against company & local GMP standards
• Examines the regulations / procedures of the Ministry of Health in line with company strategies, ensures compliance with them and undertakes the responsibility for them
• Manages the product and service supplier processes within the scope of Quality requirements. Ensures supplier qualification, organizes, and conducts inspections and participates
• Ensures that the procedures related to the quality system are prepared, updated, and trained in accordance with Janssen International Quality System Guidelines, “Good Manufacturing Practice” and “Good Distribution Practice”
• Checks the format conformity of newly published or updated procedures
• Ensures systematic management of parameters measuring process efficiency within the scope of the Quality System
• Provides support to the LOC CQ Head and RM in systematically managing the parameters measuring process efficiency within the scope of the Quality System and sharing them periodically with the management team
• Obtains and reviews the annual product evaluation reports in accordance with the Quality System
• Ensures the management and tracking of Quality Issues, CAPA and Deviation management and CoC processes
• Ensures that the annual Internal and External Audit Plans are prepared, and these audits are carried out
• Conduct regular (self-)inspections of GMP/GDP practices that are applicable on the supply chain within the responsibilities of the Local Operating Company
• Support to the LOC CQ Head and RM in recall and escalation situations
• Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management
• Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes
• Implement departmental strategies and services as the business expert on quality systems, distribution, and quality management in collaboration with Enterprise Commercial Quality, implement common distribution standards and Quality Management Systems (where appropriate)
• This role will optimize quality systems and processes and ensure alignment with the worldwide

• Ensures compliance with relevant agreements, legal requirements, ethical standards, Corporate Business and Security Procedures and HCBI.
• Contributes to the LOC CQ Head and RM in terms of being ready for audit
• Fulfills confidentiality principles

• Participates in training programs and applies newly acquired knowledge and skills
• Gains in-depth knowledge of “Good Manufacturing Practice” legislation and other relevant Official Regulations and Laws
• Contributes to the LOC CQ Head and RM to prepare and carry out trainings for Company employees and 3rd party employees

• Provides effective feedback to the LOC CQ Head and RM on potential system development issues
• Works towards continuous improvement and development of the Quality Management System. Interaction with Business Partners
• Collaborates effectively with business partners (Logistics Department, Finance, Medical, Regulatory Affairs, PV, Sales & Marketing, Sales Operations, Warehouse Operations, Deliver, External Manufacturers, Logistics, etc.)

• Ability and agility to deliver high-quality, high value technology solutions understanding of use of automated techniques and tools
• Provide technology solution requirements in a manner that can be easily consumed by the business, design, build, test, training, and operations
• Work towards a solution via artificial intelligence, use new platforms
• Understanding of the definition of the term; the implications for people, processes, and technology
• Contributes to support the digital transformation efforts of the CQ and business
• And essential elements of data science, science applications and innovations, and supports for creation a common data science vocabulary

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