QA Compliance Specialist

Lonza•Portsmouth, NH

1d•Onsite

About The Position

As a QA Compliance Specialist, you will leverage your knowledge and expertise to support the Cell Therapy (CT) Quality Management System (QMS). In this role, you will act as a change agent—driving compliance, promoting inspection readiness, and supporting key review boards—while contributing to continuous improvement initiatives to ensure adherence to all applicable regulatory requirements.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field
Working knowledge of GMP regulations and guidelines (e.g., ICH Q7–Q11, 21 CFR Parts 210, 211, 600–680, 820)
Strong written and verbal communication skills, with the ability to effectively engage stakeholders at all levels
Experience with quality and enterprise systems such as DMS, TrackWise, SAP, Syncade, or similar platforms
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
High attention to detail with strong organizational, analytical, and problem-solving skills
Self-motivated and adaptable, with the ability to manage changing priorities and workload effectively
Ability to work both independently and collaboratively within a team environment
Sound judgment with the ability to identify issues, present solutions clearly, and escalate when appropriate
Experience in a regulated environment

Nice To Haves

cell therapy or biologics experience is a plus

Responsibilities

Support and continuously improve the CT Quality Management System (QMS) to ensure compliance with applicable regulations and internal standards
Serve as a compliance champion by promoting inspection readiness, modeling quality behaviors, and supporting cross-functional review boards (e.g., DRB, CAPA Review Board, Change Control Board)
Independently review and approve controlled documents within the Document Management System (DMS), including SOPs, work instructions, forms, and validation/qualification protocols and reports
Ensure all documentation changes are accurate, justified, and compliant with established procedures; escalate complex issues as needed and collaborate with stakeholders to resolve them
Participate in deviation investigations and the CAPA lifecycle, supporting root cause analysis and ensuring effective corrective and preventive actions
Partner with subject matter experts (SMEs) to identify and close gaps in procedures, processes, and policies to maintain compliance with regulatory requirements (e.g., Annex 1, CFRs)
Monitor and support key quality metrics (KPIs/KQIs), identify trends, and take action to drive continuous improvement
Build strong cross-functional relationships with Manufacturing, MSAT, QC, and other teams to foster a strong quality culture
Provide guidance and coaching on GMP principles to promote compliance and operational excellence
Manage multiple priorities effectively in a dynamic, fast-paced environment