Overall purpose of job
To support establishment and maintenance of overall OneSEA quality management framework and quality system, including creation and maintenance of the Business Quality Manual, deployment and training of Business Quality SOPs, and implementation of the OneSEA Internal and Supplier Audit Program. This role is also responsible for the preparation and monitoring of Non-Conformance and Corrective and Preventive Actions to mitigate potential or actual non-compliance risks, and the creation and tracking of Change Control Requests arising from QMS related changes.
Essential duties and responsibilities
- Work with the BQS Director, BQS Manager and OneSEA BQ Community to identify opportunities and create initiatives to harmonize quality processes across sectors and countries.
- Manage the planning and execution of Internal and Supplier Audits in LOCs from Auditor Qualification, Schedule and Agenda preparation to Audit execution.
- Support in preparation for JJRC Audits, and participate in assessments when appropriate. Review recommendations of auditors and assist in the generation of mitigation actions/corrective action plan for BQS process related observations.
- Lead or support Quality System initiatives to develop and roll out standardized IT systems, processes and training across OneSEA to meet BQ needs and promote consistency and simplification.
- Support the Qualification and Training process through maintenance of OneSEA Training Matrix, deployment of OneSEA Training topics in Summit Learning Management System and generation of training completion reports for Management review.
- Support adherence to J&J Quality Policy (POL1) in OneSEA, while promoting consistency of processes and systems employed by OneSEA LOCs.
- Support compliance to all J&J Quality Policy and Technical Standards and regulatory requirements, where applicable, including Internal Audit, NC/CAPA, Change Control, Document Control, Quality Records Management and Regulatory Standards Management.
- Cross-Sector/Functional Partnership – The ability to work in a group of people from different sectors with different functional expertise towards achieving a common goal, including members from all levels internal/external to the organization.
- Enterprise Mindset – The mental attitude to embrace and understand not only your own functional silo, but the enterprise business process to create value to customers and shareholders, and to improve overall business process and success.
- Local Market Acumen – The ability to understand and adhere to key local market compliance standards to meet quality requirements and market needs.
Essential knowledge and skills
- Degree qualified from an accredited university.
- Relevant business experience in quality role, and have good understanding and a desire to develop the quality management system within OneSEA.
- Background on internal and supplier audits, and compliance knowledge preferably on ISO standards.
Core competencies required for this role
- Sufficient knowledge on J&J Quality and Technical Standards, BQ SOPs, Sector/Regional procedures, GxPs, regulations, and other quality systems and guidelines.
- Working knowledge of quality and operations systems and processes.
- Leadership, collaboration, and interpersonal skills.Communication, presentation and management skills.
- Displays initiative and able to independently create and deliver.
- Quality and organizational sense.