CAPA/NC/Root Cause Leader
Job Description SummaryWe are excited to be recruiting for a newly created role of a CAPA/NC/Root Cause Leader to be part of a global Central Quality Team. As a subject matter expert, you will provide critical support to the Global Process Owner on the strategic and tactical direction for three Quality System Elements: CAPA, Non-Conformance, & Root Cause Analysis.
You will drive the Inspire Quality Initiative within the BD Quality Team improving, harmonising and introducing new processes around the world in relation to CAPA, Non-Conformance, & Root Cause Analysis.
This role can be located anywhere in the EU.
The CAPA/NC/Root Cause Leader while acting in accordance with all applicable federal, state, and local laws/regulations and Corporate BD, procedures and guidelines, will be responsible for:
- Data analysis and data mining regarding CAPA/NC/Root Cause.
- Identify trends and opportunities across BD within CAPA/NC/Root Cause.
- Responsible for preparing presentations for global management review.
- Contributor in developing policies, procedures, templates, and tools for CAP/NC/Root Cause.
- Accountable for entering metrics into the BD global systems, follow up and escalate metrics, as appropriate.
- Responsible for the development and organization of the CAPA/NC/Root Cause network and meeting cadence.
- Contributor to the training of the CAPA/NC/Root Cause network participants. Setting curricular.
- Monitors internal and external audit observations within BD.
- Monitors for regulatory changes in the field and completes gap assessments.
- Supports regulatory inspections and audits.
- Supports work with the IT Teams to for the implementation of key system solutions across BD including development and execution of test scripts.
The successful candidate will be educated to degree level or equivalent. You will have good I.T. skills in particular, data analysis tools, QMS Software and MS Office. You will be an expert with Root Cause Analysis tools. You will have excellent Technical Writing skills.
You will be an effective communicator at all levels and be able to use these skills to collaborate, influence and implement change. You will be driven with an exceptional attention to detail and a ravenous appetite for processes, systems and data.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please APPLY.
Primary Work LocationGBR Plymouth - Belliver Industrial Estate
Additional LocationsAUT Vienna - Handelskai, BEL Erembodegem - Dorp 86, CHE Eysins - Business Park Terre-Bonne, DEU Frankfurt - Walther-von-Cronberg-Platz, DNK Helsingor, FRA Le Pont-de-Claix Cedex, HUN Budapest - Dobrentei, IRL Dun Laoghaire - Pottery Road, ITA Rome, LUX Luxembourg - rue d'Esch, NOR Oslo, SVK Slovakia Field, SWE Helsingborg – Florettgatan
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