LSA QA Sr. Compliance Specialist

Lonza • Portsmouth, NH

3d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior