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
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, 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.
Ready to shape the future of life sciences? Apply now.
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