Associate Director IT Applications

3 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

As a Associate Director within IT Applications, you will lead the Global Laboratory Systems team within the Information Technology function and will be responsible for managing the system lifecycle development, maintenance and compliance activities for Laboratory software and process control systems in our QC, Chemistry, Micro and Process Sciences labs. These systems include but are not limited to Nugenesis SDMS, Compliance Builder and bench top computer systems and instrument software such as Endoscan V, SoftMax Pro and DataPro2.

As an Associate Director within IT Applications, a typical day might include, but is not limited to, the following:

  • Manages team responsible for global operations, system administration and enhancements of Nugenesis SDMS, Compliance Builder and bench top computer systems and instrument software such as Endoscan V, SoftMax Pro and the Global IOPS organization.
  • Supervises the Lab Systems team including performance management and people development activities.
  • Work with business teams and IT leadership to help develop strategy for a growing organization and team.
  • Technical coach and mentor for resources in their direct organization.
  • Coordinates the needs of functional departments and establishes priorities for Laboratory Systems requirements gathering, system design and implementation.
  • Develops and revises methods, record keeping, policies and procedures for Laboratory Systems in compliance with regulations and guidance.
  • Investigates and resolves computer software and IT hardware issues with QC instrumentation.
  • Collaborates with relevant QA organizations to ensure validated QC computers and software are maintained in a validated state.
  • Implements change control following established procedures.
  • Supports validation of Laboratory following SDLC design methodology.
  • Performs related duties as assigned.

This role may be for you if you:

  • Recognize the importance of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production, should display a high level of integrity in the performance of his/her work.
  • Passionate about quality / right first time
  • Organised and good documentation skills
  • Proven ability to support Applications in a highly regulated environment
  • Knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11
  • Knowledge of helpdesk ticketing systems such as Service Now advantageous
  • Knowledge of Regulatory Asset Manager Systems advantageous
  • Excellent written and oral communication skills
  • Good IT skills and knowledge of standard software packages (e.g., Microsoft Word, Excel, Teams etc.,)
  • Possess excellent customer facing skills allowing comfortable traversing of cross departmental levels
  • Ability to think analytically and learn quickly
  • Manage Operational budgets
  • ITIL certified
  • Project Management trained

In order to be considered for this position, you must hold a Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field

  • Associate Director: 10 + years industry experience
  • Director: 12+ years of relevant experience in lab/IT setting, or may substitute relevant experience in lab/IT setting for educational requirement.

May consider experience in lieu of education; level decided upon completion of an interview process

  • Additional Experiences:
  • 8-10+ years of managing employees and budgets
  • 7-10+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment
  • Experience with IT Compliance guidelines as per GAMP 5

#REGNIEEC #JOBSIEST #IRELIM #LI-Onsit

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. #J-18808-Ljbffr

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