QA Project Manager II- Operations

Lonza•Portsmouth, NH

30d•Onsite

About The Position

The QA Project Manager II serves as the primary Quality liaison for one or more external customers, ensuring quality and compliance requirements are met across customer programs. This role manages and coordinates key quality activities including change controls, deviations, investigations, CAPAs, Product Quality Reviews, and Quality Agreements. The position works closely with internal teams such as MSAT, Manufacturing, Engineering, and Quality Control to facilitate communication, resolve quality issues, and ensure customer expectations and regulatory standards are consistently met.

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.
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.

Nice To Haves

Experience with SAP, TrackWise, and Microsoft Office Suite preferred.

Responsibilities

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.