QA Specialist IV-QRM

QA Specialist IV - QRM

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 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 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.

• 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

What we are looking for:

• 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

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

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.