Requisition ID 17913BR
Title Sr. Analyst, IT QC
Job Category Information Technology
Job Description PURPOSE:
Ensures fulfillment of the IT Quality Control (ITQC) responsibilities and ITQC support for IT systems supporting orders, samples, customer service and other regulatory areas. Scope includes approximately 14 systems supporting approximately 3000 users, and related projects. This includes preparation, review and approval of quality management documentation according to Novo Nordisk Quality System, advice on quality matters, and assistance for closing compliance gaps found in audits and inspections.
RELATIONSHIPS:
Reports to a manager in the Manager, IT Governance and Quality and works under general direction. The position works with Project Managers, System Managers, Business Analysts, Application Development members, Infrastructure and Ops team, members of the Quality Department, Global IT and ITQC Partners and external vendors.
ESSENTIAL FUNCTIONS:
• Utilizes knowledge of the assigned business functions to identify business needs and develop value-added solutions
• Recognizes and responds to stakeholder needs and ensures commitments are delivered upon
• Clearly communicates with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions
• Partners with stakeholders to assess, develop and implement solutions to meet their business need
• Applies knowledge of business and industry to assist with the decision making process
• 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
• Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding IT policies, solutions and initiatives
• Develops and communicates compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
• Facilitates cross-functional collaboration among necessary stakeholders when making decisions and developing strategic plans
• Promotes and gains support for ideas by negotiating and establishing clear, positive links between ideas and key business needs
• Delivers messages and presentations to various, cross-functional groups to gain support for strategic initiatives and ideas
• Demonstrates an understanding of many relevant IT areas and their applications
• Utilizes knowledge of relevant IT areas to recommend existing solutions to client needs
• Manages tasks according to the project plan, goals and timelines and coordinates with others
• Supports the allocation of resources by accurately communicating availability
• Works collaboratively with project teams to keep them informed of project status, including any barriers
• Utilizes expert knowledge of risk management standards and practices to influence, develop and mentor others and ensure compliance of local and global systems
• 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
• Applies comprehensive knowledge of external risk management changes and influences the development of new standards to be followed by the organization
• Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
• Utilizes expert knowledge regarding risk management practices, and leads and mentors a team through the system life-cycle
PHYSICAL REQUIREMENTS:
Approximately 5% overnight travel
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required; an advanced degree preferred; solid relevant experience may be substituted when appropriate; additional certifications a plus
• A minimum of 10+ years of related experience in the pharmaceutical industry required
• A minimum of 8 years of progressively responsible Computer Science, IT, programming/systems analysis or other related experience required
• Project management experience or cross functional team lead experience required Strong QA analyst skills with experience in computer systems validation in GxP environments in a pharmaceutical industry required
• Must have the ability to work effectively in a highly matrixed team environment
• Demonstrates superior written and oral communication skills
• Must have excellent Microsoft Office skills with Microsoft
• Experience authoring validation protocols, VSSs, SOPs, Validation Plans and test scripts is required
• Knowledge of Novo Nordisk Quality Management process and Computer Systems Validation principles a plus
• Strong skills in interdependent partnering and influencing
• Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
• Work is performed with limited direction
• Independently determines and develops approach to solutions and may determine long-term solutions
• Demonstrates leadership capabilities; has the ability to act as project lead in the development and implementation of processes and programs
Department FIN - IT GOVERNANCE & QUALITY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%
Title Sr. Analyst, IT QC
Job Category Information Technology
Job Description PURPOSE:
Ensures fulfillment of the IT Quality Control (ITQC) responsibilities and ITQC support for IT systems supporting orders, samples, customer service and other regulatory areas. Scope includes approximately 14 systems supporting approximately 3000 users, and related projects. This includes preparation, review and approval of quality management documentation according to Novo Nordisk Quality System, advice on quality matters, and assistance for closing compliance gaps found in audits and inspections.
RELATIONSHIPS:
Reports to a manager in the Manager, IT Governance and Quality and works under general direction. The position works with Project Managers, System Managers, Business Analysts, Application Development members, Infrastructure and Ops team, members of the Quality Department, Global IT and ITQC Partners and external vendors.
ESSENTIAL FUNCTIONS:
• Utilizes knowledge of the assigned business functions to identify business needs and develop value-added solutions
• Recognizes and responds to stakeholder needs and ensures commitments are delivered upon
• Clearly communicates with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions
• Partners with stakeholders to assess, develop and implement solutions to meet their business need
• Applies knowledge of business and industry to assist with the decision making process
• 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
• Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding IT policies, solutions and initiatives
• Develops and communicates compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
• Facilitates cross-functional collaboration among necessary stakeholders when making decisions and developing strategic plans
• Promotes and gains support for ideas by negotiating and establishing clear, positive links between ideas and key business needs
• Delivers messages and presentations to various, cross-functional groups to gain support for strategic initiatives and ideas
• Demonstrates an understanding of many relevant IT areas and their applications
• Utilizes knowledge of relevant IT areas to recommend existing solutions to client needs
• Manages tasks according to the project plan, goals and timelines and coordinates with others
• Supports the allocation of resources by accurately communicating availability
• Works collaboratively with project teams to keep them informed of project status, including any barriers
• Utilizes expert knowledge of risk management standards and practices to influence, develop and mentor others and ensure compliance of local and global systems
• 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
• Applies comprehensive knowledge of external risk management changes and influences the development of new standards to be followed by the organization
• Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
• Utilizes expert knowledge regarding risk management practices, and leads and mentors a team through the system life-cycle
PHYSICAL REQUIREMENTS:
Approximately 5% overnight travel
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required; an advanced degree preferred; solid relevant experience may be substituted when appropriate; additional certifications a plus
• A minimum of 10+ years of related experience in the pharmaceutical industry required
• A minimum of 8 years of progressively responsible Computer Science, IT, programming/systems analysis or other related experience required
• Project management experience or cross functional team lead experience required Strong QA analyst skills with experience in computer systems validation in GxP environments in a pharmaceutical industry required
• Must have the ability to work effectively in a highly matrixed team environment
• Demonstrates superior written and oral communication skills
• Must have excellent Microsoft Office skills with Microsoft
• Experience authoring validation protocols, VSSs, SOPs, Validation Plans and test scripts is required
• Knowledge of Novo Nordisk Quality Management process and Computer Systems Validation principles a plus
• Strong skills in interdependent partnering and influencing
• Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
• Work is performed with limited direction
• Independently determines and develops approach to solutions and may determine long-term solutions
• Demonstrates leadership capabilities; has the ability to act as project lead in the development and implementation of processes and programs
Department FIN - IT GOVERNANCE & QUALITY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%