11 часов назад
Director, Quality Systems
191 500 - 247 500$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Quality Systems (Pharmaceutical Quality Assurance): Developing and maintaining compliant quality systems for a biotechnology company with an accent on document management, training compliance, change control, CAPA, deviation management, and quality metrics. Focus on validating MasterControl, supporting inspection readiness, coordinating international quality systems staff, and driving continuous improvement across functions and sites.
Location: Framingham, United States; 5-day on-site expectation
Salary: $191,500–$247,500 annual base pay, plus performance bonus, equity, and benefits.
Company
is a biotechnology company developing oncolytic immunotherapies designed to activate systemic anti-tumor immune responses and transform cancer treatment.
What you will do
- Oversee and maintain the compliant Quality System in line with ICH Q10 and applicable US and international regulations.
- Manage document control, training compliance, change control, deviation management, CAPA, and quality metrics reporting.
- Monitor Quality System health, report risks to management, and drive cross-functional improvement initiatives.
- Lead inspection readiness activities, including risk mitigation, inspection responses, interim controls, and CAPA plans.
- Lead and support the international quality systems team while partnering across functions, sites, and time zones.
- Oversee the implementation, validation, maintenance, and business use of MasterControl electronic quality systems.
Requirements
- At least 10 years of experience in Quality Assurance or Quality Systems within the pharmaceutical industry.
- Experience with electronic documentation systems and inspection management.
- Bachelor’s degree or equivalent required; a biological or pharmaceutical advanced degree is preferred.
- Experience working cross-functionally across multiple sites and/or time zones.
- Strong verbal and written communication, conflict management, negotiation, independent working, and collaboration skills.
Nice to have
- Project management or operational excellence experience with Lean, Six Sigma, or both.
- Continuing education or an advanced degree in a biological or pharmaceutical field.
Culture & Benefits
- Purpose-driven work focused on improving outcomes for patients and caregivers.
- Collaborative, bold, committed, and candid working principles.
- Medical, dental, and vision insurance.
- 401(k) matching, flexible time off, paid holidays, and year-end shutdown.
- Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.
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