3 дня назад
Assistant Manager of Quality
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Assistant Manager of Quality (Plasma Quality and Regulatory Compliance): Maintaining an inspection-ready plasma donation center through quality systems, SOP adherence, audits, CAPA, and regulatory compliance with an accent on GMP standards, KPI analysis, and deviation management. Focus on leading quality control programs, investigating root causes, coordinating remediation, and developing quality staff in a regulated biopharma environment.
Location: Auburn, Alabama, United States; onsite
Company
operates a global plasma donation network supplying plasma-derived therapies through CSL, a biopharma company.
What you will do
- Maintain an inspection-ready center through SOP adherence, quality systems, compliance policies, self-inspections, and remediation.
- Manage the site Quality Control program, including calibrations, sampling, competency checks, KPI monitoring, trending, root cause analysis, and change management.
- Lead and develop quality staff, including recruiting, performance reviews, education, and corrective actions.
- Lead supplier, customer, and regulatory audits; coordinate findings, CAPA remediation, and timely closure.
- Investigate deviations, determine root causes, monitor CAPA effectiveness, and escalate events affecting product safety, quality, identity, purity, or potency.
- Support process improvements that enhance donor service and product yields while maintaining regulatory compliance and safety.
Requirements
- Bachelor's degree in a scientific, life sciences, or related discipline.
- 5+ years of experience in quality and regulatory work, preferably in the plasma industry.
- Demonstrated leadership or supervisory experience.
- Knowledge of government and industry regulations, GMP standards, HSE, and OSHA requirements.
- Work onsite in Auburn, Alabama, United States.
Culture & Benefits
- Work in a dynamic, regulated biopharma environment focused on lifesaving plasma-derived therapies.
- Maintain a clean, efficient, and safety-focused work environment.
- Follow established HR, confidentiality, health, safety, and environmental policies.
- Access employee benefits.
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