LSA QA Sr. Compliance Specialist

About the role

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.

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

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

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

Qualifications

None specified

Skills

None specified

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)

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge

Schedule

The typical work schedule is Monday through Friday, 7:00 AM–4:00 PM EST