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5 дней назад

Sr. Manager, Quality Excellence (Life Sciences)

155 000 - 175 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr. Manager, Quality Excellence (Life Sciences): Leading quality assurance, quality control, quality engineering, and laboratory functions while maintaining and optimizing a compliant QMS at a regulated manufacturing site with an accent on FDA, ISO, cGMP, audit, validation, CAPA, and risk management requirements. Focus on building high-performing quality teams, driving Lean and Six Sigma process improvement, leading audits and management reviews, and using KPIs and root-cause analysis to improve site performance.

Location: On-site in Hauppauge, New York, United States. Travel up to 10% to other Cytiva manufacturing locations in the US and worldwide.

Salary: $155,000–$175,000 annually, plus bonus or incentive pay.

Company

Cytiva is a hirify.global operating company developing solutions for life sciences, biotechnology, vaccines, medicines, and cell and gene therapies.

What you will do

  • Lead Quality Control, Quality Assurance, Quality Engineering, and Quality Laboratory functions at the Hauppauge site.
  • Serve as the site Quality Management Representative and ensure regulatory compliance, customer satisfaction, and effective quality operations.
  • Implement, maintain, and optimize the Cytiva Quality Management System, including procedures, work instructions, and supporting IT systems.
  • Partner with site and global leadership on process changes, change management, product development, and customer-focused solutions.
  • Build and develop a high-performing quality department with emphasis on psychological safety, physical safety, coaching, and continuous improvement.
  • Lead management reviews, audits, risk assessments, KPI monitoring, and executive or global best-practice initiatives.

Requirements

  • Bachelor’s degree in science or engineering, or 10+ years of equivalent experience in regulated manufacturing.
  • At least 7 years of experience in quality, quality engineering, or manufacturing operations within life sciences, biotechnology, medical device, biopharma, or another FDA/EPA-regulated manufacturing environment.
  • At least 5 years of leadership experience; experience leading both Quality Engineering and Quality Laboratory functions is preferred.
  • Knowledge of ISO 9001, ISO 13485, FDA regulations, cGMPs, CFR requirements, validation, CAPA, complaints, audits, risk management, and operational controls.
  • Experience with statistical quality methods, Lean Manufacturing, Six Sigma, Gage R&R, test schedules, and root-cause analysis.
  • Ability to work on-site in Hauppauge and travel up to 10%. The role also requires accessing equipment 5–6 feet above ground and lifting or moving 20–35 lb. parcels.

Nice to have

  • Analytical chemistry or microbiology experience in an ISO 17025 environment.
  • Experience with contamination control, sterilization, sanitation, E-beam, or ISO 14644.
  • Experience with SAP, Oracle, Veeva, or Magic.

Culture & Benefits

  • Paid time off and comprehensive medical, dental, and vision insurance.
  • 401(k) benefits for eligible employees.
  • Bonus or incentive pay eligibility.
  • Culture focused on belonging, continuous improvement, innovation, and measurable impact in human health.

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