LSA QA Sr. Compliance Specialist

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 7:00 AM–4:00 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:

The Sr. QA Compliance Specialist serves as a key member of the Quality Assurance organization and acts as a subject matter expert for Quality Systems and GMP Compliance. This role is responsible for driving inspection readiness, strengthening quality systems, and promoting a strong quality culture across the site. The successful candidate will partner cross-functionally with Manufacturing, QC, Validation, Engineering, and site leadership to ensure compliance with regulatory requirements and continuous improvement of quality processes.

• Serve as a subject matter expert for Quality Systems, GMP Compliance, and inspection readiness activities across the site

• Lead and facilitate Quality Review Boards, including Deviation Review Board, CAPA Review Board, Change Control Board, and Quality Council meetings

• Review and approve deviations, investigations, CAPAs, change controls, SOPs, and other quality records to ensure compliance with internal procedures and regulatory requirements

• Identify compliance gaps, process improvements, and risk mitigation opportunities while driving effective corrective and preventive actions

• Support internal audits, customer audits, and regulatory inspections, including coordinating and authoring audit responses and commitments

• Generate, trend, and communicate Quality Metrics, KPIs, and KQIs to support management review and continuous improvement initiatives

• Provide GMP guidance, coaching, and training to cross-functional teams while promoting a sustainable culture of quality and compliance

• Effectively manage multiple priorities and support site initiatives, special projects, and other duties as assigned

What we are looking for:

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline preferred

• Minimum 5+ years of experience in Quality Assurance, Compliance, or Quality Systems within a GMP-regulated pharmaceutical or biotechnology environment

• Strong knowledge of cGMP regulations, including FDA 21 CFR Parts 210/211, EU GMP Annex 1, and applicable ICH guidelines

• Demonstrated experience managing deviations, CAPAs, change controls, investigations, and quality risk assessments

• Experience supporting regulatory inspections, customer audits, and inspection readiness activities in a manufacturing environment

• Strong analytical, organizational, and critical-thinking skills with the ability to make sound quality and compliance decisions

• Excellent written and verbal communication skills, including technical writing and cross-functional collaboration abilities

• Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, MasterControl, or similar systems preferred