QA Operations Lead, GMP Biopharma

Lonza; Portsmouth (NH); Presencial; USD 110 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Agile culture and dynamic working env.

Lead and develop a QA team

Exposure to complex biologics and QA/O

Collaborative cross-functional team

Performance-based compensation plans

Medical, dental, and vision insurance

Career growth and leadership programs

Resumo da oferta

Lonza is seeking a QA Operations Manager (Day Shift) in Portsmouth, NH to lead a high-performing QA team overseeing manufacturing quality, batch review, and product disposition readiness in a GMP setting.

The role partners with Manufacturing and Technical Operations to drive continuous improvement and ensure compliance, inspection readiness, and staff development in a fast-paced environment.

Qualificações

• 7+ years of Quality Assurance experience in a GMP-regulated biopharmaceutical/pharma environment.
• 3+ years of supervisory or management experience in QA.
• Strong knowledge of FDA/EMA/global GMP requirements including deviations, CAPAs, investigations, change controls, and product disposition processes.
• Proven leadership with ability to coach teams, manage priorities, and drive CI initiatives.

Responsabilidades

• Lead daily QA Operations activities with quality oversight for manufacturing operations and regulatory compliance.
• Manage batch documentation review, product disposition readiness, and documentation quality for timely product release.
• Provide quality guidance and risk-based decision-making for manufacturing activities and quality events.
• Oversee deviations, investigations, CAPAs, change controls, risk assessments, and quality event management.
• Lead, coach, develop, and resource-plan QA Operations personnel fostering a collaborative, accountable team.
• Partner with Manufacturing, Supply Chain, Technical Operations, and Quality to identify risks and resolve issues.
• Drive operational excellence through metrics, standardization, and new systems/processes implementation.

Conhecimentos

QA leadership

GMP knowledge

Leadership

Communication

Problem-solving

Risk assessment

Cross-functional collaboration

Formação académica

Bachelor's in Life Sciences

Advanced degree preferred

Descrição da oferta de emprego

Lonza is seeking a QA Operations Manager (Day Shift) in Portsmouth, NH to lead a high-performing QA team overseeing manufacturing quality, batch review, and product disposition readiness in a GMP setting.

The role partners with Manufacturing and Technical Operations to drive continuous improvement and ensure compliance, inspection readiness, and staff development in a fast-paced environment.