QA Compliance Specialist
About the role
The position is located in Portsmouth, NH, with a typical work schedule of Monday through Friday from 8:00 AM to 5:00 PM EST.
Responsibilities
- Leverage knowledge and expertise to support the Cell Therapy Quality Management System (QMS).
- Act as a change agent, driving compliance, promoting inspection readiness, and supporting key review boards.
- Contribute 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).
- Maintain 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.
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).
- A high attention to detail with strong organizational, analytical, and problem-solving skills.
- A self-motivated and adaptable individual with the ability to manage changing priorities and workload effectively.
- Experience in a regulated environment; cell therapy or biologics experience is a plus.
Qualifications
- None specified.
Skills
- Knowledge of GMP regulations and guidelines.
- Strong communication and collaboration skills.
- Experience with quality management systems.
- Proficiency in Microsoft Office.
- Attention to detail and problem-solving skills.
- Experience in a regulated environment.
- Cell therapy or biologics experience (optional).
Benefits
Performance-related bonus. Medical, dental, and vision insurance. 401(k) matching plan. Life insurance, short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation is determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Pay
TBD
Schedule
Monday through Friday, 8:00 AM–5:00 PM EST
Lonza
At Lonza, our people are our greatest strength. 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.