Top 335 Director, qa validation & computer systems assurance Jobs in Schenectady, Ny

Director, QA Validation & Computer Systems Assurance
Regeneron —Saratoga Springs, NY
- $172,200 - $286,900 a year
- Monday to Friday
- Computer Science
- 5 years
- Bachelor of Science
- Health insurance
- Dental insurance
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Saratoga Hospital —Saratoga Springs, NY
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- $90,000 - $100,000 a year
- Overnight shift
- Nursing
- RN License
- 5 years
- Paid holidays
- Loan repayment program
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Highway Director
Town of Colonie —Latham, NY
- $115,210 - $121,274 a year
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- Master's degree
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Ascend Autism —Latham, NY
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Rail Modal Group —Latham, NY
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Director of Student Support Services
Albany Leadership Charter School for Girls —Albany, NY
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Rehab Director SNF Speech Language Pathologist
Rosewood Rehabilitation and Nursing Center —Rensselaer, NY
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Genesis Medical Health, PC —Albany, NY
- $225,000 - $275,000 a year
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- Management
- Travel reimbursement
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Assistant Director of Nursing
Wilkinson Residential Health Care Facility —Amsterdam, NY
- $105,000 - $125,000 a year
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- RN License
- Mid-level
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4d
Director of Surgical Services
Clinical Management Consultants —Schenectady, NY
- $125,020 - $165,530 a year
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Assistant Director of Compliance and Quality Assurance
Liberty ARC —Amsterdam, NY
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Regional Director of Golf Outreach and Veteran Engagement
Guardian Outreach Ministries Inc —Albany, NY
- $80,000 - $150,000 a year
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- 3 years
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9d
Director of Talent Management
Partnership Solutions —Albany, NY
- $130,000 - $155,000 a year
- Full-time
- 5 years
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Assistant Director of Nursing
Conifer Park Inc —Glenville, NY
- $95,000 - $115,000 a year
- Full-time
- CPR Certification
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Resident Care Director
Peregrine Senior Living at Clifton Park —Clifton Park, NY
- $70,000 - $75,000 a year
- Full-time
- Mid-level
- Paid holidays
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Director, QA Validation & Computer Systems Assurance

Regeneron -
Saratoga Springs, NY

Apply Now

Job Details

$172,200 - $286,900 a year

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance
401(k) matching

Qualifications

GAMP
Team leadership
Enterprise software
FDA 21 CFR Part 11
ICH Q9
Manufacturing facility experience
Production validation processes
Pharmaceutical company experience
QA/QC
ICH Q10
Supervisory control and data acquisition (SCADA)
System development
Laboratory information systems (LIS)
Manufacturing
Pharmaceutical manufacturing facility experience
IT risk management

Full Job Description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of QA Validation to lead the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for the Regeneron manufacturing site located in Saratoga Springs, NY. The director is responsible for qualification and validation strategy across a highly automated, digitally integrated biopharmaceutical facility, including process equipment, utilities, manufacturing execution systems (MES), laboratory information management systems (LIMS), distributed control systems (DCS), and enterprise platforms. The role applies risk-based methodologies aligned with FDA CSA guidance, GAMP 5 (2nd ed.), ICH Q9(R1)/Q10, and SDLC frameworks to maintain validated state across commercial and clinical manufacturing, and represents and defends the validation and CSA programs during FDA, EMA, and other regulatory inspections.

When & where:

Location: Saratoga Springs, NY and Rensselaer, NY
Work model: Monday-Friday, 8am-4:30pm

Discover your role:

Own and maintain the site Validation Master Plan (VMP), including scope for process, cleaning, sterilization, utilities, and equipment qualification across GMP manufacturing areas
Design and implement risk-based qualification and requalification programs consistent with current FDA, EMA, and ICH guidance
Ensure validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) meets regulatory expectations for commercial and clinical programs
Lead periodic review programs to maintain validated state for equipment, utilities, and automated systems
Lead the CSA program in alignment with FDA's 2022 CSA guidance and GAMP 5 (2nd ed.), shifting from prescriptive CSV toward risk-based, fit-for-purpose assurance activities
Own the site SDLC framework governing qualification and assurance of GxP-relevant software and computerized systems, including MES (e.g., Syncade, PAS-X), DCS/SCADA, LIMS, EBR, ERP integrations, and data historians
Establish critical thinking and scripted/unscripted testing strategies based on software category, intended use, and risk to product quality and patient safety
Oversee supplier/vendor assessments for software used in GxP contexts, including software development lifecycle practices and audit readiness
Ensure data integrity by design across automated and integrated systems, including audit trail configuration, access controls, and electronic records compliance (21 CFR Part 11/Annex 11)
Partner with IT, automation, and manufacturing engineering teams to integrate CSA requirements into system procurement, development, and change management processes
Provide QA oversight for qualification of highly automated systems, including continuous manufacturing platforms, inline/online/atline PAT instruments, and automated material handling systems
Partner with automation and digital transformation teams to ensure GxP requirements are embedded in future-state manufacturing architecture, including digital twin environments
Review and approve GxP documents including validation protocols and reports, CSA plans and assessments, change controls, deviations/failure investigations, risk assessments, SOPs, and the VMP
Provide QA validation and CSA oversight within the site change control system, ensuring impact assessments and requalification/revalidation requirements are properly scoped
Maintain periodic review programs for validated processes and qualified systems, including metrics-driven risk prioritization
Present and defends validation and CSA programs during FDA, EMA, and other regulatory agency inspections; leads preparation of inspection-ready documentation and staff readiness
Monitor evolving regulatory guidance (FDA, EMA, PIC/S, USP) relevant to validation, CSA, data integrity, and computerized systems
Lead, develop, and retain a team of validation scientists, engineers, and CSA specialists across a complex, multi-system GMP environment
Develop and manage validation and CSA budgets, contractor resources, and schedules; sets performance objectives and manages hiring and separation activities
Collaborate with Manufacturing, Engineering, Automation, IT, and Regulatory Affairs to align validation and CSA strategies with site priorities and enterprise digital initiatives; communicates program status and risk posture to senior leadership
Support global quality alignment across Regeneron manufacturing facilities on validation and CSA standards and best practices

This role requires:

BS/BA required in Engineering, Computer Science, Life Sciences, or related field; advanced degree preferred
12+ years of experience in pharmaceutical or biopharmaceutical manufacturing, including at least 7 years in validation, CSA, or quality assurance roles
5+ years of people management experience in a GxP environment
Direct experience leading computer systems assurance or CSV programs for commercial biologics or pharmaceutical manufacturing sites required
Working knowledge of SDLC methodologies applied to GxP software (GAMP 5, 2nd ed.), FDA CSA guidance (2022), 21 CFR Part 11, EU Annex 11, and ICH Q9(R1)/Q10
Experience with MES, DCS/SCADA, LIMS, and ERP/EBR systems in a GMP context required
Experience representing validation and CSA programs in regulatory inspections (FDA PAI, BPAI, or EMA inspections) preferred
Strong working knowledge of risk management principles and their application to validation and software assurance decisions

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$172,200.00 - $286,900.00

Apply Now

Refine Your Search

director, qa validation & computer systems assurance jobs in schenectady, ny

Director, QA Validation & Computer Systems Assurance

Director of Pre/Post Surgical Services

Director of Perioperative - Operating Room and Endoscopy

Director of Health Services

Highway Director

Director of Speech and Occupational Therapy

Sr. Advisor or Director, Advanced Nuclear

Associate Clinical Director (BCBA)

Director or Sr. Director

Director of Logistics

Director of Student Support Services

Rehab Director SNF Speech Language Pathologist

Medical Director / Attending Physician – Skilled Nursing Facility (SNF)

Assistant Director of Nursing

Director of Surgical Services

Assistant Director of Compliance and Quality Assurance

Regional Director of Golf Outreach and Veteran Engagement

Director of Talent Management

Assistant Director of Nursing

Resident Care Director

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