layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Manager, Quality Assurance at Lonza, Portsmouth, NH

What you will do

Lead the QA Operations Batch Record Review team, providing daily oversight of batch record review activities and ensuring timely, compliant release support
Recruit, train, coach, and develop QA Batch Record Reviewers while managing team workload, resource planning, and performance
Provide guidance on quality and compliance observations, including severity assessments and determination of when quality records are required
Partner with Manufacturing teams to review and resolve batch record and electronic batch record observations, ensuring accurate and compliant documentation
Assess, review, and approve deviations, CAPAs, investigations, change controls, effectiveness checks, extensions, and other quality records in accordance with site procedures
Serve as the primary Quality partner for Manufacturing Operations, supporting batch disposition activities, quality-related inquiries, and operational decision-making
Represent Quality Assurance on cross-functional teams while driving continuous improvement initiatives, quality strategy development, inspection readiness, and Quality Management System effectiveness

What we are looking for

Bachelor's degree in a scientific discipline required
5-10 years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotech, or life sciences environment
Prior experience leading, mentoring, coaching, and developing direct reports
Strong working knowledge of GMP regulations, quality systems, deviations, CAPAs, investigations, and change control processes
Experience supporting regulatory inspections, customer audits, and quality compliance activities
Experience with systems such as TrackWise, SAP, Syncade, and Microsoft Office applications preferred
Excellent communication, decision-making, problem-solving, and stakeholder management skills with the ability to influence across all levels of the organization

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Manager, Quality Assurance

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What you will get

Compensation programs that recognize high performance

What you will do

What we are looking for

About Lonza

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