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For your reference, we have included the original job posting below.
Sr. Quality Systems Specialist of Computer Systems Validation Job
Job Number:
25494323
Company Name:
Novo Nordisk
Job Location:
Princeton, NJ US
Job Categories:
Information Technology Research
Sr. Quality Systems Specialist of Computer Systems Validation Job
Auto req ID 3166BR Title Sr. Quality Systems Specialist of Computer Systems Validation Job Category Quality Job Description PURPOSE: This position is responsible for the planning, documenting, development and execution of the qualification and validation for all GXP and critical IT systems. Assures compliance of IT processes with applicable Federal and State regulations and the Novo Nordisk Quality System. Participates in cross-functional teams as necessary.
RELATIONSHIPS: Position reports to Senior Manager, Quality Systems. Works closely with internal (IT) and external partners involved in quality systems and validation activities. External relationships include interactions with NNI vendors and colleagues at other Novo Nordisk affiliates globally. Internal relationships include interactions with all NNI business units, especially IT, as well as counterparts based at Headquarters. Build, develop and grow any business relationship vital to the success of the project. Assist in identifying and resolving issues and conflicts within the project teams. Interact with IT System Managers and System Owners to provide guidance and assure compliance with applicable procedures and regulations.
ESSENTIAL FUNTIONS:
QUALITY SYSTEMS Primary Quality representative responsible for all computer system validation efforts at NNI, from project inception to implementation to ongoing system support. Actively participates in continuous improvement initiatives targeting all aspects of business at NNI, with a primary focus on IT-related systems. Provides back-up support for multiple NNI Quality functions. Assists with training processes, both within the Quality organization and externally throughout Novo Nordisk. Participates in all IT system assessments, audit activities and quality initiatives with formal review and approval responsibility. Review and approval of remediation efforts, testing and qualification plans and reports, non-conformities, and other organized activities and processes related to critical IT systems.
AUDITS/VALIDATION Assists in all internal and external audits, for compliance to GxP system and Novo Nordisk Quality requirements. Primary audit responsibility for IT vendors and systems. Sets the validation strategy and approach for IT Systems Interprets relevant regulations and procedures to apply and support within the Information Technology department
CROSS-DEPARTMENT COLLABORATION Trained in, and assists in the management and operations of cross-departmental processes, as needed. Liaise with counterparts at headquarters and other affiliates to form a consistent IT quality strategy.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Bachelors Degree required A minimum of 10 years IT experience required, preferably in the pharmaceutical industry. Strong QA analyst skills with experience in computer system validation in GxP environments. IT Audit experience desirable. Solid interpersonal / communication skills. ISACA's Certified Information Systems Auditor (CISA) certification a plus. Additional Information OTHER: Works within Novo Nordisk's established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals. Embraces Novo Nordisk Values in spirit and actions. Approximately 15% overnight travel
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management's assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned. Department LGQ - QUALITY SYSTEMS Position Location Princeton, NJ Job/Position State NJ Degree Required Bachelor's Degree Required Percent Travel 10 - 20%
