1 день назад
Manager of Quality Assurance (Biotechnology)
100 000 - 120 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager of Quality Assurance (Biotechnology): Developing and operating an ISO 9001-certified Quality Management System across the Seattle biotech site with an accent on qualification, raw material management, product release, and quality system execution. Focus on managing deviations and CAPA, change control, risk management, and harmonizing quality practices across production, QC, and R&D.
Location: United States; site responsibilities cover Seattle, Washington, with the posting also listing Redmond, Washington and Piscataway, New Jersey.
Salary: $100,000–$120,000 annual total compensation, including bonus, depending on experience and qualifications.
Company
is a biotechnology company providing life-science research services and products, biologics CDMO solutions, synthetic products, and cell therapy services worldwide.
What you will do
- Lead the strategic development and operational management of the site’s ISO 9001-certified Quality Management System.
- Ensure consistent execution of quality systems across multiple production lines, QC groups, and R&D.
- Manage facility, utility, and equipment qualification activities.
- Establish and maintain quality systems, raw material controls, production process support, and product release processes.
- Oversee deviation, CAPA, change management, and risk management activities.
Requirements
- Experience managing quality assurance systems in a biotech, life-science, or manufacturing environment.
- Knowledge of ISO 9001 quality management requirements.
- Ability to support production, QC, and R&D operations across a site.
- Capability to manage qualification, product release, deviations, CAPA, change control, and risk management.
- Full-time work at the U.S.-based site is required.
Culture & Benefits
- Medical, dental, and vision insurance.
- 401(k) retirement plan with a company match that fully vests on the first day.
- Paid parental leave after three months of employment.
- Paid vacation, personal, sick, floating holiday, and company holiday time.
- Flexible spending and health savings accounts, disability coverage, commuter benefits, well-being initiatives, and recognition programs.
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