Sr. Manager, System Quality Compliance Job
Location: Bridgewater New Jersey
Description: Johnson & Johnson is presently looking of Sr. Manager, System Quality Compliance Job right now, this position will be placed in New Jersey. For complete informations about this position opportunity kindly see the descriptions. Johnson & Johnson companies are equal opportunity employers.
Sr. Manager, System Quality Compliance-00000CR4
Description
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
J&J is pursuing a tran! sformational Complaint Management solution that focuses on qua! lity as a competitive advantage. It will deliver a common process, organization, and technology solution that supports medical device and diagnostic product complaints across the J&J organization.
The Senior Manager, System Quality Compliance manages and is accountable for all quality requirements for the program on a global basis. This individual is responsible for providing expert advice to applicability of any regulatory and/or compliance aspects (ex. Software Quality, SOX, FDA, Security, Privacy) to the development team to ensure that the computerized system can be validated. Responsible for providing expert advice into the project Compliance Analysis, determining which regulations are relevant to the project. Responsible for approving the Compliance Plan and reviewing and approving relevant SDLC deliverables per that plan. Consults with project team to ensure adherence to the SDLC. For validated and/or SOX applicable systems, approves the Compliance Report. Pa! rticipates in stage gate reviews. Prepares for test execution - reviews test approach, cycles, timelines, and protocols.
Qualifications
A Bachelor's degree (or equivalent) is required. An advanced degree is preferred. A minimum of 8 years of business experience is required. Demonstrated strong organizational, interpersonal and communication skills are required. Demonstrated strong team leadership, and a proven track record of leading and developing teams is a plus. Breadth of experience in all areas of compliance and regulation, devising and implementing SOPs, and testing and monitoring is required. Experience with software quality validation protocols is required. Familiarly with system development lifecycle processes and procedures is required. Knowledge of Sarbanes-Oxley is required. Knowledge of internal controls is required. The ability to influence without authority is required. Strong collaboration and teaming skills are required.
The prefe! rred location for this position is Bridgewater, New Jersey, however thi! s position can also be located at any J&J location globally. Up to approximately 10% domestic and international travel may be required.
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J2W: LI
Primary Location: North America-United States-New Jersey-Bridgewater
Other Locations: Europe/Middle East/Africa, North America, North America-Canada, Latin America, Asia Pacific
Organization: MD&D Global Services LLC (6209)
Job : Quality Systems
Relocation: Eligible
No
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If you were ! eligible to this position, please email us your resume, with salary requirements and a resume to Johnson & Johnson.
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This position starts available on: Sat, 29 Jun 2013 03:21:20 GMT