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Portsmouth, New Hampshire, United States
Onsite
QA Compliance Specialist
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 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.
What you will do:
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.
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
What we are looking for:
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; cell therapy or biologics experience is a plus
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.