Within this role 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:
- Managing the 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 DataPro2.across the Global IOPS organization
- Supervising the Lab Systems team including performance management and people development activities
- Working with business teams and IT leadership to help develop strategy for a growing organization and team
- Technical coaching and mentoring for resources in their direct organization
- Coordinating the needs of functional departments and establishing priorities for Laboratory Systems requirements gathering, system designing and implementing
- Developing and revising methods, record keeping, policies and procedures for Laboratory Systems in compliance with regulations and guidance
- Investigating and resolving computer software and IT hardware issues with QC instrumentation
- Collaborating with relevant QA organizations to ensure validated QC computers and software are maintained in a validated state
- Implementing change control following established procedures
- Supporting validation of Laboratory following SDLC design methodology
- Performing 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, you should display a high level of integrity in the performance of his/her work
- You have proven ability to support Applications in a highly regulated environment
- You possess the knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11
- You have knowledge of helpdesk ticketing systems such as Service Now advantageous
- You have knowledge of Regulatory Asset Manager Systems advantageous
- You possess excellent customer facing skills allowing comfortable traversing of cross departmental levels
- You have the ability to think analytically and learn quickly
- You can manage Operational budgets
- You are ITIL certified
- You are 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 Experience:
- 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.
#JOBSIEST #IRELIM #LI-Onsite
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.