Supplier Quality Management Specialist- Somerset NJ

Reports to : Regulatory and Compliance Manager

Summary of Essential Functions:

This position is responsible for ensuring the quality of products sourced from external suppliers by overseeing supplier assessments, audits, and supplier performance management. The role involves ensuring compliance with all relevant regulatory standards (such as cGMP), implementing corrective action plans (CAPAs), driving continuous improvement initiatives, and collaborating with internal teams, including procurement and manufacturing, to maintain product quality throughout the supply chain.

• Supplier Quality Management – Experience in managing supplier relationships, conducting audits, supplier qualification, and performance monitoring.

• cGMP Knowledge – Understanding of current Good Manufacturing Practices (cGMP) regulations and how they apply to the pharmaceutical industry, ensuring compliance across the supply chain.

• Audit and Compliance – Ability to conduct supplier audits, assess quality systems, and ensure adherence to regulatory standards (e.g., FDA, ICH).

• Data Analysis – Strong analytical skills to interpret complex data, identify trends, and solve quality-related issues effectively using quality tools and statistical analysis.

• Corrective Action and Continuous Improvement – Experience in implementing Corrective Action Plans (CAPAs) and driving continuous improvement initiatives to resolve quality issues and enhance supplier performance.

• Technical Writing and Documentation – Proficiency in reviewing and managing technical quality agreements (TQAs), supplier documentation, and ensuring all records are in compliance with regulatory requirements.

• Cross-functional Collaboration – Strong communication and interpersonal skills to work effectively with internal teams (e.g., procurement, manufacturing, quality assurance, and product development) and external suppliers.

• Supplier Performance Reviews – Ability to assess and provide feedback on supplier performance, track supplier quality metrics, and ensure corrective actions are implemented.

• Change Control Management – Experience in reviewing and approving supplier change controls, ensuring that changes do not negatively affect product quality.

Education and Experience:

• Bachelor’s degree required, preferably in a pharmaceutical or technical field. 3+ years of experience in pharmaceutical/biological manufacturing, packaging, and laboratory operations. Extensive knowledge of cGMP regulations and quality principles within the pharmaceutical industry. Proven experience in supplier quality management, including conducting supplier audits, supplier qualification, and performance monitoring.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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 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. 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 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.