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.
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About Kelly
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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.
