QA Operations Leader - Biopharma Manufacturing

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

On-site on Portsmouth facilities

Job summary

Lonza Group Ltd. in Portsmouth, NH is seeking a QA Operations Manager (Day Shift) to lead a high‑performing QA team responsible for quality oversight of manufacturing operations, batch documentation review and product disposition readiness in a fast‑paced GMP environment.

You will influence quality strategy, mentor a growing team, and partner across Manufacturing, Supply Chain and Technical Operations to ensure inspection readiness and continuous improvement.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline (advanced degree preferred).
• 7+ years of Quality Assurance experience in GMP biopharmaceutical/pharma/biotech settings.
• 3+ years in supervisory/management roles within a QA organization.
• Experience with manufacturing quality oversight, quality systems and batch documentation review.
• Strong knowledge of FDA/EMA/global GMP requirements including deviations, CAPAs, investigations, change controls and disposition processes.
• Proven leadership with ability to coach teams, manage priorities and drive improvement.
• Excellent communication, problem-solving, stakeholder management and risk-based decision making.

Responsibilities

• Lead daily QA Operations activities with quality oversight for manufacturing; ensure cGMP compliance.
• Manage batch documentation review, product disposition readiness and documentation quality for timely release.
• Provide quality guidance and risk-based decisions 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; foster a collaborative, accountable team environment.
• Partner with Manufacturing, Supply Chain, Technical Operations and Quality to identify risks and support operational success.
• Drive operational excellence via metrics, standardization and implementation of new systems and processes.

Skills

QA Leadership

Quality Oversight

Batch Documentation

Regulatory Knowledge

CapA & Deviations

Education

Bachelor's degree in Life Sciences

Job description

Lonza Group Ltd. in Portsmouth, NH is seeking a QA Operations Manager (Day Shift) to lead a high‑performing QA team responsible for quality oversight of manufacturing operations, batch documentation review and product disposition readiness in a fast‑paced GMP environment.

You will influence quality strategy, mentor a growing team, and partner across Manufacturing, Supply Chain and Technical Operations to ensure inspection readiness and continuous improvement.