Associate Director IT Applications - Tarrytown, United States - Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals, Inc Tarrytown, United States

1 week ago

Full time

Description

The IT department is hiring The Associate Director IT Applications - Lab Systems position leads the Global Laboratory Systems team within the Information Technology function and is 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, a typical day might include 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

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