Sr. Manager Technology Quality
Locations: Beerse, Belgium
Functions: Quality Systems
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Requisition ID: 1905717270W
Johnson & Johnson is recruiting for a Sr. Manager Technology Quality, Healthcare Technology to be located in EMEA.
Johnson & Johnson Family of Companies, caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
Global Quality IT - Healthcare Technology ensures compliance of systems across the enterprise in accordance with J&J SDLC, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections.
You, the Manager Technology Quality, Healthcare Technology is responsible for supporting the project team through the day to day project activities under the supervision and direction of function head. The purpose of this role is to assist and work closely with the Project Manager for project planning and execution activities.
You, The Manager Technology Quality, Healthcare Technology is responsible for
* Reviewing and approving validation deliverables of healthcare technology products and infrastructure to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
* Supporting internal and external Health Authority regulatory inspections.
* The approval of lifecycle/design controls documentation deliverables including the approval to release system implementation and/or changes for production use.
* In conjunction with franchise quality assurance teams, provide quality oversight in support of engineering, release and post-market support activities for:
* SaMD - Standalone software medical devices (i.e. mobile, wearables, web applications)
* SiMD - Medical devices with embedded software
* Hardware integrated solutions such as software driven surgery systems (robotics)
* Digital manufacturing and 3D printing
* Medical device infrastructure, including IaaS and internal hosting of product software
* Providing quality guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
* Perform pre and post review and approval of validation test scripts including test defects
* Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
* Ensure a high degree of Inspection Readiness for Systems in GQ-IT portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within scope of responsibility
* Ensure a high degree of Inspection Readiness for Systems in software medical device portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within scope of responsibility
* Participate in audits, approves audit non-conformity action plans
* Demonstrates an understanding of many relevant Quality and Compliance principles and their applications
* Leads and mentors a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices.
* Assist or drive status meetings to communicate and address project risks or issues
* Works collaboratively with project teams to keep them informed of project status, including any barriers
* Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
* Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
* Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
* Provide an environment which encourages the company's credo and diversity of opinions and thoughts
* Ensure timely completion of assigned training and expense reporting
* Develop and maintain an effective working partnership with senior management.
* Collaborate with other leaders and staff within GQ-IT HCT group to ensure each function is executed in an efficient manner.
* Ensure timely reports of status, metrics and time sheets as required by the GQ-IT organization
* Ensure timely completion of assigned training and expense reports
* A Bachelor's degree and a minimum of 8 years of progressive experience in the healthcare or biotech industry is required.
* Direct experience in Computerized System Validation activities is preferred.
* A degree in Computer Science, Information Systems, Business Administration or other related field is preferred.
* Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required.
* Strong QA skills with experience in Computerized System validation in GxP environments in the healthcare industry required.
* Strong experience and knowledge working with medical device regulations and standards such as 21 CFR 820, ISO 13485 etc. is preferred.
* Experience with medical device software, including standalone and embedded systems is preferred.
* Experience with integrated hardware projects such as robotics and 3D printing platforms is preferred.
* Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands is required.
* Must have the ability to work effectively in a highly matrixed systems environment is required.
* Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly preferred,
* Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is preferred.
* Experience in Testing Management Tools like HPALM is required.
* Superior written and oral communication and excellent Microsoft Office skills required.
* Strong skills in interdependent partnering and influencing required.
* Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar is preferred.
* This position will be located in Providence RI and may require up to 10% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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