Commercial Quality Professional

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Overall purpose of job:
The Commercial Quality (CQ) Professional is responsible for receiving, processing and reporting of Product Quality Complaints associated with the use of Janssen Cilag Pty. Ltd. products in accordance with Regulatory and Company requirements, and leading and managing all Product Quality Complaints requirements of allocated company projects.

Essential duties and responsibilities:

• Complaint Processing - Receive, log, review and process product quality complaints in accordance with regulatory guidelines and local and global standard operating procedures (SOPs); Take the lead in communication and follow-up with customer in a timely manner, including provision of acknowledgment and close-out letters; Lead the regular liaison with
• Medical Information and Drug Safety to ensure timely identification (especially Lack of Efficacy), management and follow up of all reports with PQC implications; Manage the timely notification of Janssen Quality leaders if any cases need escalation; Manage queries from all stakeholders within the J&J organisation in a timely manner; Manage the review of
• closure reports in a timely manner; Manage TGA & Medsafe enquiries in a timely manner with relevant internal stakeholder consultation.
• Retrieval of Complaint Samples / Shipment to Manufacturer - Manage the retrieval of complaint samples and all necessary information/documentation from customers within appropriate timelines; Lead the inspection of incoming complaint samples; Send complaint samples or complaint sample photos to manufacturer for investigation; Document and
• file all transactions.
• Reconciliation – Lead and manage the conduct of regular reconciliation activities within the PQC function, and across Medical Information and Drug Safety in line with relevant SOPs.
• Filing & Archiving – Ensure compliant filing and archiving systems are in place for the storage and retrieval of all source documents according to local and global requirements; Assist with periodic archiving of documents.
• Business Unit support and review of local clinical, health economic and marketing proposals and protocols for PQC reporting requirements – Support the review of all allocated local clinical (Phase I-IV), Product Access (e.g. SAS, NPP, Compassionate, etc...), health economic, market research and other marketing proposals for implementation of and compliance with all regulatory and company PQC reporting requirements; Provide input into PQC sections of local protocols and proposals as required; Support processes for collection and maintenance of documentation for company activities with PQC reporting requirements
• Training – Participate in the provision of PQC training as and when required; Complete all allocated personal training within required timeframes.
• Standard Operating Procedures – As and when required, assist in the review of SOPs, the provision of impact assessments or gap analyses, and in the preparation of new SOPs to ensure local compliance to global, regional and regulatory requirements.
• Metrics and Management Reporting –Participate in the collation and preparation of reports of KPIs and other measures, as and when required.
• Audit Support – Assist with audits and the preparation for internal and external audits, and any allocated follow-up actions.
• Contribute to any other activities per direct manager or Commercial Quality Head request.

Special requirements

• English proficiency;
• Empathic communication
• Digital savvy;
• High computer literacy
• Process and detail-oriented
• Customer-centricity
• Perseverance