QA Manager, OTF Support

General Information

Name


QA Manager, OTF Support


Employment Type


Direct Hire


Position level


Full-time


Virtual/Remote?


No


Labor Category


Scientific


Date


28-May-2026


City


Winston Salem


State


North Carolina


Country


United States


Ref #


9247853046


Description & Requirements

Description

Manager, QA Floor Support - Winston-Salem, NC

Step into a high-visibility leadership role where your expertise in Quality Assurance directly impacts the success of clinical and commercial manufacturing. We're seeking a QA Floor Support Manager who thrives in fast-paced, highly regulated environments and is ready to lead from the front-on the floor, in real time.

This is your chance to shape quality operations, drive commercial readiness, and build a high-performing team in an advanced manufacturing setting.
Position Overview

As the QA On-The-Floor (OTF) Manager , you will lead QA floor operations at a cGMP manufacturing site, providing real-time quality oversight across clinical and commercial activities. Reporting into senior quality leadership, you'll play a critical role in maintaining compliance, ensuring inspection readiness, and partnering cross-functionally to keep operations running in a state of control.

This is a fully onsite role in Winston-Salem, NC , requiring flexibility to support multiple shifts.
What You'll Do
Lead & Develop a High-Impact Team

• Manage, coach, and grow a team of 3-4 direct reports (with expected expansion)
• Ensure team members are fully trained, qualified, and performing at a high level
• Oversee daily assignments, documentation review, and floor support activities
• Maintain team readiness, including gowning qualifications and procedural training

Own QA Presence on the Manufacturing Floor

• Provide hands-on, real-time QA oversight during manufacturing operations
• Conduct routine walkthroughs, observe processes, and reinforce cleanroom behaviors
• Align QA support schedules with manufacturing needs
• Identify, document, and escalate GMP issues or atypical events

Drive Quality Decisions & Operational Excellence

• Make critical QA decisions related to room/equipment release, line clearance, and batch review
• Support deviations, change controls, alarms, and return-to-service activities
• Partner with Manufacturing to troubleshoot issues and implement corrective actions
• Evaluate QA performance on the floor and implement continuous improvement plans

Ensure Compliance & Inspection Readiness

• Oversee timely review of GMP documentation, including batch records, logbooks, and testing data
• Author and revise SOPs and quality procedures
• Support internal audits, regulatory inspections , and ongoing compliance initiatives
• Maintain strict standards for data integrity and documentation accuracy

Collaborate Across Functions

• Work closely with Manufacturing, Quality Control, Supply Chain, and Facilities
• Participate in cross-functional teams and process improvement initiatives
• Help drive commercial readiness in a rapidly evolving environment

What We're Looking For

• Bachelor's degree in a scientific or related field
• 5+ years of QA experience in cGMP aseptic/sterile manufacturing (on-the-floor experience strongly preferred)
• Direct leadership experience with a track record of developing teams
• Strong knowledge of FDA, EU, and ICH regulatory requirements
• Experience in cell therapy or advanced therapies -especially through commercialization-is highly preferred
• Proven ability to make decisions in real time , influence teams, and drive alignment
• Excellent organizational, analytical, and communication skills
• Ability to manage multiple priorities in a fast-paced environment

What's in It for You

• Competitive salary: $114,000 - $127,000
• 15% performance bonus
• Relocation assistance to Winston-Salem, NC
• Opportunity to play a key leadership role in a growing, cutting-edge manufacturing environment

Location Requirement

This role is fully onsite in Winston-Salem, NC . Candidates must be willing to relocate and live in the area.

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.