Novex Innovations
Position: Quality Assurance Manager
Location: Winston-Salem, NC
Company Overview:
Novex Innovations is a rapidly growing, privately held contract development and manufacturing organization (CDMO) headquartered in Winston-Salem, North Carolina. We help clients navigate the journey from pre-clinical development through commercialization across biologics, pharmaceuticals, and medical devices.
At Novex, we are scaling quickly, investing in our future, and building a collaborative, high-performance culture. We value initiative, accountability, and a solutions-driven mindset while keeping client needs at the center of our work.
Job Summary:
The Quality Assurance Manager at Novex Innovations is a hands-on QA leader responsible for supporting GMP-compliant biopharmaceutical, pharmaceutical, tissue, and medical device-related operations in a multi-client CDMO environment. This position provides day-to-day QA oversight for manufacturing, laboratory, documentation, quality system, supplier, client, and audit activities.
The ideal candidate will combine practical QA judgment, strong communication skills, and direct experience in regulated manufacturing environments with working knowledge of aseptic processing, clean-room operations, batch documentation, deviations, CAPAs, change control, training, and inspection readiness. This is an operational QA role that requires close partnership with Manufacturing, Science & Technology, Regulatory, Client Programs, and leadership to keep client programs compliant, well documented, and executable.
Key Responsibilities:Quality Assurance Operations and On-the-Floor Support:
· Provide hands-on QA support in laboratories, controlled work areas, clean rooms, and manufacturing spaces.
· Support aseptic and controlled-environment operations by reinforcing gowning practices, clean-room behavior, contamination control, approved procedures, and Good Documentation Practices.
· Identify and escalate quality, documentation, training, or process issues and help drive practical, risk-based resolution.
Quality Management System and Documentation:
· Manage or support core quality processes, including deviations, CAPAs, change controls, complaints, training, document control, supplier quality, and audit readiness.
· Review and approve, as appropriate, batch records, master batch records, laboratory records, protocols, reports, deviations, OOS/OOT events, CAPAs, and related GMP documentation.
· Ensure quality records are complete, accurate, timely, and consistent with applicable SOPs, GMP expectations, Good Documentation Practices, and client requirements.
Client, Audit, and Regulatory Support:
· Serve as a primary QA point of contact for assigned client programs, client audits, quality discussions, technology transfer activities, and routine production support.
· Prepare for and support client audits, supplier audits, internal audits, and health authority inspections, including responses and follow-up actions.
· Support client and regulatory documentation requests related to development, manufacturing, testing, technology transfer, and CMC-related activities.
Supplier Quality, Training, and Quality Culture:
· Support supplier qualification, vendor oversight, material quality review, contract laboratory oversight, and supplier-related quality events.
· Develop, deliver, and reinforce practical GMP, GDP, aseptic behavior, documentation, and quality system training.
· Promote a quality culture based on accountability, timely escalation, clear documentation, and practical problem solving.
Team Leadership and Cross-Functional Coordination:
· Coordinate closely with Manufacturing, Science & Technology, Quality Control, Regulatory, Client Programs, and leadership to support compliant program execution.
· Supervise, mentor, and develop QA personnel or quality support staff as assigned.
· Balance client expectations, regulatory requirements, operational realities, and quality system discipline in a fast-paced CDMO environment.
Qualifications:
· Bachelor's degree in biology, chemistry, biotechnology, pharmaceutical sciences, engineering, or a related scientific or technical field required; advanced degree preferred but not required.
· Minimum of 7 years of relevant QA, Quality Operations, Quality Systems, or compliance experience in a pharmaceutical, biopharmaceutical, biologics, cell therapy, tissue, sterile/aseptic, or related regulated manufacturing environment.
· Minimum of 3 years of supervisory, team leadership, project leadership, or cross-functional quality leadership experience.
· Direct experience supporting GMP manufacturing, laboratory operations, clean-room operations, aseptic processing, or controlled work areas required.
· Working knowledge of GMP expectations, SOPs, work instructions, batch records, deviations, CAPAs, change control, training, supplier qualification, audit support, and Good Documentation Practices.
· Ability to make sound, risk-based quality decisions under time pressure while maintaining compliance, documentation discipline, and appropriate escalation.
· Excellent written and verbal communication skills, strong organizational skills, attention to detail, and ability to manage multiple client programs, quality events, audits, and documentation priorities.
Additional Preferences:
· Prior experience in a CDMO, CMO, contract testing, or other multi-client regulated service environment strongly preferred.
· Experience with biologics, sterile fill/finish, cell therapy, HCT/Ps, tissue banking, or complex biologically derived products is highly desirable.
· Familiarity with FDA requirements, including 21 CFR Parts 210, 211, and 600 where applicable; experience with ICH guidance, EU GMP expectations, or quality/regulatory certifications is a plus.
Working Environment:The work is performed in a combination office, laboratory, clean-room, and manufacturing environment. The position requires direct interaction with internal teams, clients, auditors, suppliers, and visitors, and will involve time in controlled work areas. The employee must follow applicable safety, quality, gowning, aseptic behavior, documentation, and facility procedures when entering laboratory, clean-room, or manufacturing spaces. Occasional travel may be required for client meetings, audits, supplier visits, or con
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Vision insurance
Work Location: In person
