QA Specialist IV-QRM

Lonza•Portsmouth, NH

14d•Onsite

About The Position

The QA Specialist IV – Quality Risk Management (QRM) plays a critical role in ensuring compliance with cGMP regulations by advancing and maintaining an effective, site-wide risk management program. This individual serves as a subject matter expert in QRM principles and tools, partnering cross-functionally to embed risk-based decision-making into quality systems and operational processes. The role is responsible for facilitating risk assessments, providing technical guidance, and driving continuous improvement initiatives to enhance product quality, patient safety, and regulatory compliance. This position operates with a high degree of independence while aligning with broader organizational and global quality objectives.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree preferred)
5–8+ years of experience in a GMP-regulated environment within Quality Assurance, Quality Systems, or related function
Strong working knowledge of cGMP regulations (FDA, EMA, ICH) and application of Quality Risk Management principles (ICH Q9)
Proven experience leading and facilitating risk assessments using tools such as FMEA, HACCP, Fishbone, What-if analysis, and process mapping
Demonstrated ability to design and implement practical, compliant, and inspection-ready risk management solutions
Experience developing and delivering technical training to diverse audiences
Strong analytical and problem-solving skills, with the ability to assess risk impact and drive effective mitigation strategies
Excellent communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organization
Ability to manage multiple priorities and lead projects independently in a fast-paced environment
Familiarity with data integrity principles and regulatory expectations
Experience supporting audits and inspections, with the ability to clearly defend QRM approaches and decisions

Nice To Haves

Certification in Quality (e.g., ASQ CQE/CQA) or formal risk management training is a plus

Responsibilities

Ensure compliance with cGMP regulations by supporting and advancing the site’s Quality Risk Management (QRM) program as a key component of the overall Quality System
Serve as a subject matter expert (SME) on QRM principles, providing technical guidance, training, and hands-on support across departments
Partner with cross-functional teams to plan, facilitate, and execute risk assessments, including tool selection, risk evaluation, and mitigation strategies
Collaborate with departments to understand project needs and design effective, inspection-ready risk management solutions
Lead and facilitate risk assessment activities (e.g., FMEA, HACCP, What-if, process mapping), ensuring outcomes are scientifically sound and compliant
Support integration of QRM principles into day-to-day operations and decision-making across the site
Review and approve QRM documentation to ensure alignment with internal procedures and regulatory expectations
Drive continuous improvement of the QRM program through lessons learned, trend analysis, and process enhancements
Develop, maintain, and deliver QRM training materials to support site-wide knowledge and adoption
Identify and implement advanced risk management tools and methodologies to enhance program effectiveness
Support global and site-level initiatives requiring QRM expertise
Ensure adherence to Data Integrity principles in all activities in accordance with company policies and regulatory expectations
Act as a representative for the QRM program during internal audits, customer audits, and regulatory inspections
Operate with minimal day-to-day supervision while aligning work to broader organizational goals