Validation manager Jobs in USA

Kelly Science is seeking a Quality Validation Manager for a growing team located in Raleigh, NC.

Salary: $135,000/year
Shift: Monday- Friday 1st Shift
Employment Type: Full Time; Direct Hire

Summary:
As Quality Validation Manager, you will lead the Validation Team in providing excellent customer service and ensuring compliance with cGMP and FDA/EMEA regulations. Serving as the validation expert, you will oversee qualification, validation, and revalidation for site equipment, systems, processes, and facilities, and drive improvement initiatives. You’ll collaborate with cross-functional teams, conduct risk assessments, review change proposals, author and approve protocols and reports, address deviations, and maintain GMP documentation.

Job Responsibilities:

• Oversee daily operations and provide leadership for the Validation department, managing both internal staff and external contractors.
• Develop, maintain, and improve validation systems, policies, and procedures to ensure compliance with cGMP FDA/EMEA regulations.
• Manage and review validation activities, including qualifications, revalidations, risk assessments, and documentation for equipment, processes, and facilities.
• Support cross-functional teams in site projects, regulatory initiatives, and process improvements; participate in audits and inspections.
• Lead and manage large-scale validation projects, coordinate with stakeholders, supervise contractors, and drive operational excellence initiatives.

Qualifications:

• Bachelor's degree in a life sciences related field
• Minimum of 10 years’ pharmaceutical validation experience and 8 years’ of supervisory experience
• Deep knowledge of validation life cycle and protocols (IQ/OQ/PQ), steam sterilization, equipment qualification, cleaning, and process validation.
• Strong leadership, coaching, mentoring, and departmental management skills, including performance reviews and establishing group objectives.
• Ability to prioritize, multitask, communicate, and stay organized in a fast-paced, regulated manufacturing environment.
• Proficient in quality issue identification, corrective/preventative actions, regulatory compliance (cGMP, cGLP, cGXP, FDA, ICH, EMEA, 21 CFR 11), and conducting audits.
• Experience with process improvements, document approvals, troubleshooting, problem-solving, risk assessment, and supporting department goals.

Interested? Please apply today for immediate consideration!

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 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.