5 дней назад
Head of Quality Assurance, Drug Product, GMP QA
226 275 - 377 125$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Head of Quality Assurance, Drug Product, GMP QA (GMP and biologics manufacturing): Leading quality oversight for internal manufacturing sites and CDMOs with an accent on risk-based quality systems, audit readiness, batch disposition, and regulatory compliance. Focus on managing QA teams, resolving complex manufacturing quality issues, strengthening CAPA and data integrity systems, and supporting reliable global product supply.
Location: Onsite in Basking Ridge, New Jersey, United States; up to 30% global travel required.
Salary: USD 226,275–377,125 per year.
Company
is a multinational pharmaceutical company developing innovative medicines in oncology, cardiovascular disease, rare diseases, and immune disorders.
What you will do
- Lead the independent Quality Assurance organization and manage a team of 5–7 MSMQs.
- Provide quality oversight for internal manufacturing sites and contract development and manufacturing organizations.
- Oversee batch disposition, lot release, manufacturing and testing activities, complaint management, investigations, CAPA, change control, and data integrity.
- Drive audit readiness, inspection management, regulatory compliance, and communication with global health authorities.
- Partner with Regulatory Affairs, Supply Chain, Tech Unit, and global Quality leaders to ensure supply, compliance, PPQ planning, and commercial manufacturing transitions.
- Promote continuous improvement and integrated risk management across the product lifecycle.
Requirements
- Bachelor’s degree in a science-related discipline; an advanced degree is strongly preferred.
- 10+ years of experience in Quality Assurance and/or biologics manufacturing within a large multinational pharmaceutical organization.
- 10+ years of experience managing teams and leading across cultures, countries, and time zones.
- Extensive experience with audit readiness, health authority inspections, risk management, CMO oversight, and GMP QA requirements.
- Expertise in one or more of formulated bulk, filling and finishing, secondary packaging, visual or automated inspection, and associated materials such as vials, syringes, and device delivery systems.
- Strong business-level English required, both written and oral; ability to travel globally up to 30% required.
Culture & Benefits
- Work in a multinational organization with a presence in more than 30 countries.
- Collaborate with internal and external stakeholders across multiple global regions.
- Support a culture of accountability, transparency, knowledge transfer, talent development, and continuous improvement.
- Participate in strategic Quality leadership forums and initiatives.
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