Flexible Qa Startup Jobs (NOW HIRING)

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 Quality Assurance to provide quality leadership for the startup and long‑term operations of the Regeneron Drug Substance manufacturing facility located in Saratoga Springs, NY, a greenfield biologics site scheduled to begin operations in 2028.

The position is responsible for building the QA organization and digital processes needed to support facility design, commissioning, qualification, and startup, and for the ongoing QA oversight of a fully automated “plant of the future” built around high levels of technology integration, data integrity, and review‑by‑exception batch disposition.

Location: Saratoga Springs, NY and Rensselaer, NY

Work model: Monday‑Friday, 8am‑4:30pm

• Lead the QA startup strategy for the Saratoga Drug Substance facility, including quality systems build‑out, staffing, and readiness for design review, commissioning, qualification, and process validation.
• Define automation, systems integration, and data integrity requirements (e.g., MES, DCS/SCADA, historian, LIMS) needed to enable review‑by‑exception batch record disposition.
• Partner with Automation, Engineering, and IT/Data Integrity functions to design exception‑based quality control strategies, including electronic batch record rules, automated in‑process checks, and real‑time release criteria.
• Build and execute a business strategy that translates vision and corporate goals into departmental objectives for a highly automated plant of the future.
• Build and maintain a high‑performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites.
• Set the course for the future—define priorities, goals and objectives for the quality team.
• Provide direction, set performance standards, evaluate, develop performance and inspire direct reports.
• Drive the department for optimal performance, constantly raising the bar, and be accountable for the performance and results of the department.
• Ensure manufacturing quality staff are appropriately trained to support a highly automated, review‑by‑exception environment.
• Oversee exception review, in‑process testing oversight, batch record review, and quality‑on‑the‑shop‑floor responsibilities of first response to product quality issues in production.
• Provide career development and training advice and regular feedback to direct reports on company and departmental operations.
• Establish data integrity governance for automated systems, ensuring ALCOA+ principles and 21CFR Part11/Annex11 compliance from startup.
• Direct activities of resources, both internal and outside contractors/vendors/systems integrators, supporting facility digital startup and automation design.
• Lead cross‑functional teams and manage deliverables for the assigned projects; drive projects through completion within timeline, quality and budgetary constraints.
• Interface with senior management to report on project and program milestones and to present project needs.
• Ensure policies, procedures, and standards are established, consistently followed, and adhered to; develop new quality systems for a fully automated facility.
• Provide first response for Quality and Compliance issues on the manufacturing floor; review and final QA approval of deviations, protocols, change documentation, SOPs, master batch record approval, including automation/system‑based release logic.
• Ensure product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned.
• Represent the Company and directly interface with auditors during regulatory body inspections, including inspections of automation and data integrity systems.
• Ensure periodic informal audits are completed in production; lead teams for tracking of quality activities, metrics, CAPA tracking.
• Report metrics and assess data trends to work with operating departments to facilitate process improvements.
• Implement and improve operational and strategic policies and directives.
• Develop or support program development for cell culture operations, centrifugation/harvest, chromatography, UFDF, viral clearance, and aseptic dispensing in an automated environment.
• Provide leadership and direction to ensure a constant state of inspection readiness for a newly commissioned facility.
• Influence others to achieve results and challenge the status quo in designing and operating a plant of the future.

• Bachelor’s degree in Life Sciences, Engineering, or related field with at least 12+ years experience in a Quality Operations, Quality Management or manufacturing role, in cGMP biologics/Drug Substance manufacturing.
• 4+ years experience in a leadership role.
• Experience with facility startup, commissioning, qualification, and process validation for greenfield or new manufacturing facilities.
• Experience with automation systems (MES, DCS/SCADA), data integrity requirements, and review‑by‑exception quality models.
• Experience with cell culture, centrifugation, chromatography, UFDF, and aseptic dispensing operations.

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, paid time off, and family support benefits.

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.