обновлено 11 дней назад
Project End-to-End (E2E) Quality Control Lead
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Project End-to-End (E2E) Quality Control Lead (GMP/Life Sciences): Leading QC project activities for laboratory development, expansion, and operational readiness at a regulated life sciences site with an accent on GMP compliance, quality systems, and cross-functional delivery. Focus on developing and qualifying QC laboratories, managing deviations and CAPA, assessing risks, and driving operational readiness for critical therapies.
Location: Bend, Oregon, USA; fully site-based. Relocation assistance is available for eligible candidates and their families.
Company
is a global life sciences company operating more than 30 sites across five continents and supporting the manufacture of medicines.
What you will do
- Lead QC project deliverables to meet GMP requirements, regulatory expectations, and business objectives.
- Oversee development, qualification, expansion, and operational readiness of QC laboratories.
- Represent QC with project teams, Quality Assurance leadership, customers, and regulatory agencies.
- Provide quality leadership across project lifecycles, including deviation management, CAPA, risk assessments, and readiness activities.
- Develop project plans and long-term QC capabilities with senior leaders and cross-functional teams.
- Monitor risks, timelines, and compliance challenges while driving continuous improvement and successful project outcomes.
Requirements
- Bachelor’s degree in a scientific discipline; an advanced degree is preferred.
- At least 5 years of Quality Control experience in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
- Strong knowledge of QC operations, laboratory compliance, data integrity, and regulatory expectations.
- Experience leading projects or project initiatives in a regulated environment.
- Working knowledge of quality systems, including CAPA, audits, investigations, and risk management.
- Strong communication, collaboration, stakeholder management, and cross-functional leadership skills.
Culture & Benefits
- Professional growth and advancement opportunities within a global life sciences organization.
- Collaborative, inclusive, and purpose-driven workplace.
- Medical, dental, and vision insurance.
- Relocation assistance for eligible candidates and their families.
- Opportunities to lead high-visibility projects and work with senior leaders across the organization.
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