QA Compliance SpecialistLocation: 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
