Locations: Beerse, Belgium
Functions: Quality Assurance
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Requisition ID: 1805705182W
Temperature Control & Monitoring
* Responsible for reviewing and approving requirements for transport qualification.
* Responsible for adherence to temperature control and monitoring requirements during transportation and distribution.
* Support validation/qualification of temperature-controlled systems (cold chain and controlled ambient).
* Accountable for the appropriate level of investigation of temperature control excursions during transport and subsequent remediation activities and related communication
* Support temperature mapping studies.
Quality Management Systems
* Responsible for ensuring the appropriate handling of transportation related customer complaints and quality events including track and trend and mitigation of Quality related issues.
* Responsible for overseeing the controls and quality standards for Quality systems transport qualification, CAPA, NC, supplier Audits, change management.
* Responsible for management of Quality system element, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, quality review.
* Responsible for management of quality related during business Reviews of the carriers / control towers.
* Support the successful management of all Health Authority inspections (e.g., FDA, MHRA, ANSM etc.) on transportation related matters.
* Responsible for the proactive identification and mitigation of compliance risk at the Carriers / control towers through quality tools (e.g audits, and other compliance programs.)
* Support the creation of transportation risk assessments and definition of appropriate actions related
* Responsible for timely and accurate metrics and reports per J&J policies. Reporting responsibilities include (but are not limited to):
* Metric evaluation and reporting as required.
* Trending reporting as required.
* Participation of Control Towers / Carriers business Reviews.
Responsible for assuring that necessary facility licenses are available for suppliers (when applicable e.g. cross docks).
Support the department goals and objectives, and business measurements.
Carriers / Control towers Quality Management
* Responsible for establishing Quality Agreements with, qualifying of, and Q&C management of transportation suppliers.
* Support the Carriers and control towers selection and approval processes.
Responsible for actively providing Quality input and oversight on Transportation network changes.
Profile needed for this function
This role requires a diverse business background, preferably with direct experience in a J&J sector, with specific quality, regulatory and regulatory compliance competencies in the areas of: customer service, Distribution Centers or transportation. A minimum of 5 years of experience in positions of increasing responsibility, with broadly based quality management experience. Experience with the global demands of the role specifically: healthcare regulatory requirements.
* Medical Device, pharmaceutical or Consumer DC, distribution or Transport Q&C management.
* Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority.
* Compliance experience, QMS experience.
* Change management and project management experience.
* Strong presentation skills.
* Issue remediation experience.
* Collaborative approach.
* Managing complexity.
* Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
* Knowledge of ISO 9001, ISO 13485, EU Good Distribution Practices and other healthcare related regulation
Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
Undergraduate degree in engineering, scientific, business or QRC disciplines.
Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
Fluent in English, other languages as Dutch is an added value
Specific know how of systems
Preferred user level experience of Document Control systems, TruVault, Adaptiv Trackwise.
Janssen Cilag S.A.S. (7825)