Serve as the primary Quality liaison for assigned external customers, managing quality communications and ensuring alignment on compliance-related matters.
Coordinate and manage customer-related quality processes, including change controls, deviations, investigations, CAPAs, Product Quality Reviews, and Quality Agreements.
Facilitate collaboration between customers and internal teams (MSAT, Manufacturing, Engineering, QC) to resolve quality issues and support project execution.
Lead Joint Quality Team (JQT) meetings, including agenda preparation, meeting facilitation, documentation of minutes, and tracking of action items.
Participate in Internal and Joint Project Team meetings as the Quality representative and contribute to decision-making on compliance and quality matters.
Review and approve investigation reports and root cause analyses for minor and major deviations, ensuring corrective and preventive actions effectively address root causes.
Partner with internal functional teams to support and manage the change control process for customer programs.
Track, analyze, and present customer quality metrics and KPIs on a monthly and quarterly basis.
Review and approve product-specific quality documentation, including Quality Agreements, Product Quality Reviews, and Master Batch Records.
Support customer audits and ensure adherence to Data Integrity principles in accordance with Lonza policies and regulatory requirements.
Requirements
Bachelor's degree in a scientific discipline required; equivalent combination of education and experience may be considered.
5-7 years of experience in Quality Assurance within a GMP-regulated environment.
Strong working knowledge of GMP regulations and raw material compliance requirements.
Experience with SAP, TrackWise, and Microsoft Office Suite preferred.
Excellent written and verbal communication skills.
Demonstrated ability to manage multiple priorities independently in a fast-paced environment.
Strong attention to detail with the ability to collaborate cross-functionally and lead quality initiatives.
About Lonza
Ready to shape the future of life sciences?
Benefits
Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
QA PM II- Operations
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-4:30 PM EST.
What you will get:
below you will find a comprehensive summary of the benefits package we offer:
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Lonza · Us - Portsmouth, NH