5 дней назад
Sr. Manager, Quality Excellence (Life Sciences)
155 000 - 175 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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 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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
6 дней назад
Sr Auditor QA (Medical Devices/Pharmaceuticals)
92 000 - 138 000$
7 дней назад
Manager Quality Assurance, Audit (Medical Devices)
116 000 - 174 000$
5 дней назад
Sr Mgr Quality Assurance (MedTech)
122 000 - 212 750$
6 дней назад
Supervisor QC (Medical Devices)
79 000 - 119 000$
3 дня назад
Manager, Quality Control
116 750 - 146 000$
6 дней назад
Senior Director, Quality (Biopharma)
205 000 - 283 000$