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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