Johnson & Johnson Careers
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Senior QMS Associate, CLS EMEA Q&C
Requisition ID: 1805643463W
Caring for the world, one person at the time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people.
Johnson & Johnson is one of the leading health care companies in the world. Johnson & Johnson’s footprint covers sites and companies across three of its sectors - Consumer Health Care, Medical Devices and Pharmaceuticals businesses.
Senior QMS Associate Customer Logistics Services (CLS) - based anywhere in the EMEA region!
The Senior QMS Associate is the regional lead for ensuring that that the QMS IT Platforms are administered and maintained in compliance with J&J requirements. This person serves as the Company’s Subject Matter Expert on the system and corresponding QMS process, and will work within a cross-functional team comprised of Operations, Quality and Compliance and IT stakeholders from J&J globally, to monitor system functional performance, manage access controls, manage system master files, and ensure compliant application of the process and use of the system.
The Senior QMS Associate is responsible for developing, implementing, training and providing access to the IT Platforms as required by the CLS business.
Establishes the standards for IT Platform data segregation and denomination by region and by location to ensure accuracy and organization in the system.
Essential duties and responsibilities:
• Act as the subject matter expert for regional platform administration requirements.
• Ensure that site/organization QMS Platforms are deployed in alignment with current standard operating procedures.
• Responsible for training and ongoing support for IT tools and corresponding QMS processes.
• Liaise, guide and work with regional teams to identify areas for improvement in the process, IT Platform & training methods to ensure harmonization and improvement of practices across sites
• Provide regional audit/inspection readiness support.
• Provide full administrative support and user access to QMS IT Platforms.
• Attend global user forum meetings representing the regional service organizations and distribution sites as applicable
Other features of the job:
• Responsible to provide metrics required per QMS procedures in line with the use of IT Platforms & other tools
• Update of relevant standard operating procedures
Essential knowledge and skills:
• 5 years in a regulated industry, ideally Health Care sector (Medical Devices, Pharmaceutical industry).
• Experience with administrating & trouble shooting regulated QMS applications.
• Understands and has experience of Computer System Validation and 21 CFR part 11 requirements.
• Knowledge of quality system processes such as Training, Document Management, Change Control, CAPA, Investigation, Audit (knowledge of all quality system processes preferred).
• Ability to assess multiple issues, and interpret the compliance and business impact, translating into system and process requirements.
• Capability to focus and prioritize, with the ability to multitask in a fast paced dynamic environment.
• Trains others ensuring effectiveness of understanding based on the users capability and role.
• Strong Customer focus, maximizing users experience and ensuring compliance in execution.
- Excellent level of spoken and written English
- Ability to travel up to 10% of the time
- Ideally work from an easily accessible location, so that travelling would not be a discomfort
Required: Undergraduate degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent relevant industry experience if no degree.
Core competencies required for this role:
• Knowledge of cGMP's and basics in quality processes
• 2 years system admin or comparable experience in a controlled environment
• Good knowledge of Microsoft applications (Word, Excel,…).
• Excellent communication skills
• Ability to prioritize tasks and work independently
• Customer Focus
• Technical Writing experience
• A high level of accuracy and commitment to timeframes.
• Strong analytical and problem solving skills
• Ability to fit in well culturally in a complex organization
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