The PositionIndependently manage assigned API automation and IT systems throughout their lifecycle, including development, operation, maintenance, change control, incident resolution, validation and retirement. Coordinate system work and maintain controls that support reliable operation and compliance with applicable GxP, data protection, financial and company requirements.
RelationshipsAccording to the organizational chart.
Essential Functions- Manage requirements and controls for assigned systems in accordance with applicable procedures and external requirements, including security, audit trails, data integrity and retention, patching, monitoring and continuity
- Work with IT Security and subject matter experts to document and maintain appropriate system security controls
- Coordinate the validation approach and qualification testing for assigned systems to demonstrate that approved requirements are met (for example, FAT, SAT, UAT, IQ, OQ, PQ and/or GEP, as applicable)
- Develop and maintain lifecycle plans for assigned systems, including upgrades, hardware obsolescence and retirement; recommend priorities based on risk and operational needs
- Lead risk assessments and coordinate change control and validation activities for assigned systems
- Review and approve testing protocols, as authorized, to confirm that approved requirements are adequately tested
- Maintain system configurations and documented configuration baselines for assigned systems
- Maintain system documentation, including operating and maintenance standards, specifications, configuration baselines, user instructions, architecture, data flows and system assessments
- Work with subject matter experts to keep system documentation aligned with local, corporate and applicable regulatory requirements
- Coordinate user training and user support for assigned systems
- Manage user access approvals and periodic access reviews in accordance with established requirements
- Monitor user feedback and identify improvements to system usability and support
- Lead system-specific improvements and coordinate cross-functional contributors to deliver agreed scope and schedules
- Lead investigations and resolution of complex incidents and deviations for assigned systems; work with subject matter experts to implement and verify corrective actions
- Apply support standards, coordinate internal and external support and recommend improvements to procedures, service levels and incident handling
- Serve as an escalation point for support, improvements and projects involving assigned systems
- Maintain and monitor the validated state through periodic system evaluations and review of control performance against documented requirements
- Review system alarms, user access, deviations and trends; address identified risks through the applicable processes
- Prepare system records and explain the controls and lifecycle decisions for assigned systems during audits and inspections
- Manage the schedule and execution of approved upgrades, obsolescence work and retirement activities for assigned systems
- Maintains a safe work environment
- Other duties as assigned
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Way and 4 Principles in all activities and interactions with other
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.). May lift up to 33lbs/15kg occasionally and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands and or fingers. The ability to speak, listen and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand and walk. The ability to push, pull, lift, finger and grasp inside and outside conditions including temperature changes; atmospheric conditions including: odours, fumes and dust.
Qualifications- Bachelor's degree in Information Technology or related field of study from an accredited college or university preferred with a minimum of five (5) years of IT systems management experience focusing on compliance required, preferably in the pharmaceutical industry (GxP)
- Minimum of five (5) years of engineering experience operation & maintenance of IT systems preferred
- Experience supporting & troubleshooting automation/IT systems & batch processes a plus
- Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred
- Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11 &/or PIC/S Annex 11 a plus
- Functional knowledge of API processes & batch sequencing a plus
- Demonstrated ability to manage the lifecycle of assigned computer systems, including validation, operation, maintenance and retirement required
- Functional understanding of the application of statistical analysis to problem solving preferred
- Expert in GxP documentation practices required
- Excellent oral & written communication skills required
- Experience in regulatory audits & inspections required
- Demonstrated ability to plan and deliver system lifecycle work, coordinate critical milestones and resources and adapt plans to operational needs and unplanned problems required
