GLP Quality Expert

GLP QA Expert – Somerset NJ

Position Summary

Act as an experienced quality expert responsible for ensuring compliance with GLP requirements, applicable regulatory guidelines, and internal quality systems. The role independently leads complex audits, manages quality challenges and non-conformities, supports inspection readiness, and drives continuous improvement across departments.

In addition to conducting and overseeing quality activities, the GLP QA Manager serves as a mentor and resource to junior QA staff, contributes to the development of the QMS, and takes ownership of a designated QA focus area such as Vendor Qualifications, Process Audits, or Continuous Improvement.

Key Responsibilities

• Independently plan, execute, document, and follow up on complex study, facility, process, and system audits , as well as vendor qualifications.

• Prepare, review, and finalize Quality Assurance Statements and other quality documentation.

• Facilitate and support regulatory inspections and sponsor audits , including preparation, coordination, and follow-up activities.

• Take ownership of an assigned QA focus area , such as Vendor Qualifications, Process Audits, Continuous Improvement, or another area aligned with organizational priorities.

• Conduct quality risk assessments, evaluate potential impacts, and provide quality input to critical business and operational decisions.

• Lead or support investigations into deviations, non-compliances, and quality issues, including root-cause analysis and development of appropriate corrective and preventive actions.

• Assess compliance with GLP requirements, regulatory expectations, and internal procedures, identifying opportunities for improvement.

• Provide guidance and mentorship to QA Officers and junior QA staff, including participation in onboarding, training, and professional development.

• Represent QA in cross-functional and interdepartmental quality initiatives.

• Contribute to audit planning, scheduling, and prioritization based on risk and business needs.

• Support the development, maintenance, and continuous improvement of QMS.

• Maintain a high level of inspection readiness across relevant departments and processes. Proactively identify and resolve quality issues and develop practical, risk-based solutions.

• Develop and improve audit methodologies, tools, templates, and processes to enhance QA effectiveness and consistency.

Core Competencies

• Quality & Regulatory Expertise: Applies strong knowledge of GLP and regulatory expectations to ensure sustained compliance.

• Analytical Thinking: Thoroughly evaluates information, identifies trends and root causes, and reaches well-supported conclusions.

• Communication: Communicates clearly and effectively across departments, functions, and organizational levels.

• Leadership & Mentoring: Provides guidance and support to junior QA staff and contributes positively to team development.

• Assertiveness & Collaboration: Confidently raises quality concerns while maintaining constructive and supportive relationships.

• Continuous Improvement: Identifies opportunities to strengthen quality systems, audit practices, and organizational processes.

• Ownership & Accountability: Takes ownership of assigned responsibilities and QA focus areas and follows through to completion.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment\_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.