The Senior Manager, IT Applications – QC and Process Sciences is accountable for the stability, compliance, and performance of enterprise applications with a primary focus on QC & Process Sciences lab systems. You will lead the run operations for Lab Ware/LIMS, Empower, Nu Genesis, and Soft Max, ensuring validated, secure, and efficient support for IOPS quality operations. This role partners closely with QC, QA, Validation, Manufacturing, and Global IT to deliver reliable sample lifecycle management, data integrity, and audit-ready computerized systems under cGMP/GxP.

• As a Senior Manager IT Applications
• Run, a typical day might include the following:
• Lead the end-to-end run function for the QC informatics stack (Lab Ware/LIMS, Empower, Nu Genesis, Soft Max), including integrations with instruments, ERP/MES, and data repositories.
• Own service delivery for QC applications across incident, problem, change, release, and configuration management, aligning with ITIL and GMP change control.
• Maintain validated state for QC systems: risk assessments, validation plans/reports, periodic reviews, audit trail assessments, access management, backup/restore, disaster recovery, and cybersecurity controls.
• Drive data integrity (ALCOA+) by enforcing role-based access, segregation of duties, electronic signatures, audit trail review processes, and safeguarding raw and derived data.
• Partner with QC leadership and System Owners to map and optimize sample and method workflows, specifications, stability studies, and lot-release processes within LIMS/CDS/SDMS.
• Establish and monitor operational metrics and dashboards (SLA adherence, right-first-time rates, change success rate, validation cycle time, audit observation closure, system availability).
• Coordinate vendor and partner management (system integrators, instrument vendors) and oversee upgrades, patches, and technology refreshes with minimal GMP impact.
• Prepare for and support internal/external audits (e.g., FDA/EMA, client audits), drive CAPA effectiveness, and ensure sustained inspection readiness.
• Author and maintain SOPs, user guides, and training materials; deliver role-based training to QC end-users and administrators.
• Collaborate globally with Application Leads to ensure alignment, share best practices, and standardize configurations and procedures across sites.
• Communicate status, risks, and resource needs to executive stakeholders; prioritize investments based on QC operational impact and compliance risk.
• Champion continuous improvement using MDI structures, lean practices, and automation to reduce manual steps and error risk in QC workflows.
• Manage budget, capacity planning, and on-call coverage to support 24x7 QC operations during campaigns, investigations, and release activities.

This Role May Be For You If You Enjoy:

• Reviewing overnight QC system performance, audit trail exceptions, and critical incidents; triaging and assigning tasks.
• Meeting with QC, QA, and Validation to prioritize change controls and minor enhancements aligned to release timelines.
• Approving Empower project configurations or LIMS workflow updates and ensuring proper documentation and validation impact assessment.
• Conducting user access reviews, periodic system health checks, and data integrity spot audits.
• Coordinating a vendor-supported patch or instrument driver update, executing installation in a controlled, validated manner.
• Updating executive stakeholders on KPIs, risks, and mitigation plans; adjusting resources to meet key priorities.

In order to be considered for this position, you must hold a BS/BA in Information Technology or related field and 8+ years of relevant experience or equivalent combination of education and experience. 5+ of those years must include managing systems and people.

Preferred Experience:

• Demonstrated experience leading QC laboratory informatics in a cGMP/GxP environment, including run operations for LIMS, CDS, SDMS/ELN/LES.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, CSV practices, data integrity principles (ALCOA+), and audit readiness.
• Hands-on administration experience with:Lab Ware LIMS (configuration, workflow design, user roles, reporting).
• Empower CDS (project administration, privileges, audit trail, e-sig, backup/restore).
• Nu Genesis SDMS (archival, search, report management, retention).
• Soft Max Pro (method management, data export, integration considerations).
• Experience integrating lab instruments (e.g., chromatographs, balances, plate readers) via vendor toolkits/drivers; familiarity with Windows Server, Active Directory, and database technologies (e.g., SQL).
• Proven track record implementing ITIL processes within GMP change control, managing releases with minimal operational disruption.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.