Quality Manager

Quality Manager- South Brunswick, NJ

Position Summary: The Quality Manager/Sr. Manager, Quality Assurance will lead our QA system, ensuring compliance of our pilot manufacturing facility and analytical laboratory with regulatory and industry standards. This role involves planning, coordinating, and leading audits, as well as supporting regulatory inspections.

Key Responsibilities

• Maintain a robust quality system to ensure compliance with cGMP requirements in manufacturing and analytical processes.
• Manage the SOP system for the Quality unit, including review and approval of SOPs for other departments. Establish and enforce quality standards, testing materials, and product quality throughout manufacturing.
• Develop raw material standards and testing methods in collaboration with suppliers.
• Update and implement quality assurance procedures and documentation systems.
• Prepare and analyze product and process quality reports, driving continuous improvement.
• Lead the inspection readiness program to ensure preparedness for health authority inspections.
• Conduct internal audits, develop audit schedules, and manage audit improvement efforts.
• Train employees on Quality Systems and ensure compliance with regulatory guidelines.
• Investigate and resolve Out of Specification (OOS) / Out of Trend (OOT) results.
  
  

Additional Responsibilities:

• Develop and maintain an Internal Audit Program, participate in change controls and investigations. Draft, edit, and approve department procedures, ensuring compliance with regulations. Monitor regulatory changes and implement necessary updates promptly.
  
  

Qualifications and Requirements:

• Bachelor’s degree required; advanced degree (MBA, MS, or PhD) preferred in scientific, engineering, or related field.
• Minimum 8 years’ experience in regulated quality environments, ideally pharmaceuticals.
• Experience leading audits and supporting health authority inspections.
• Strong technical writing and review skills for lab investigations and regulatory documents.
• Global regulatory knowledge and strong problem-solving abilities.
• Excellent communication, negotiation, and leadership skills.
  
  

Knowledge and Skills:

• Expertise in laboratory systems/equipment (IQ/OQ/PQ), compendia (USP, EP, JP), and cGMP regulations.
• Advanced knowledge of Quality Lab Systems (e.g., Trackwise, ComplianceWire) for investigations and document management.
• Strong organizational and strategic problem-solving abilities.
  
  

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 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.