KBI Biopharma · 18 hours ago
Quality Assurance Manager
USA – NC – Kannapolis
Full-time
Onsite
Mid Level
4+ years expKBI Biopharma is a company focused on quality management in the biopharma sector, and they are seeking a Quality Assurance Manager. This role will oversee the quality management program, ensuring compliance with regulations and continuous improvement in site performance.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements
Provide support for Quality Systems and maintain the appropriate level of customer service
Prepare, host, and respond to findings for external audits (e.g.: regulatory, ISO/CAP/CLIA, client, etc.)
Prepare non conformance reports and monitoring reporting performance and trends
Problem solve, identification of root cause and implementation/follow up of corrective procedures and preventive actions to ensure timely resolution of such problems
Ability to perform internal audits as required according to site and global plans
Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate
Timely completion and follow up through to closure of CAPA actions
Measuring and monitoring of performance against agreed KPIs
Collate and share information/data across the site as appropriate through reports and follows up on identified improvement opportunities
Actively contribute to the success of the overall QA team and the site
Responsible for ensuring the company and its quality management system (QMS) meets relevant regulations and standards (e.g., FDA, QSR, ISO standards, CLIA, CAP, GLP, GDP, EH&S) and other guidelines
Oversee supplier/vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations guidelines
Managed QA department and quality activities such as document control, training, calibration, complaints, incoming inspection, nonconformance, deviation, CAPA system, supplier management system, internal and external audits
Support site EHS program
Actively participate and/or drives EU/Global QMS improvements as required
Qualification
Required
Bachelor's degree in a scientific discipline
4-5 years of related quality assurance experience
Experience with GLP/GCLP/ ISO9001 is required
Ability to work in an in-vivo laboratory environment is required
Able to make competent decisions based on a review of analytical data
Able to write clear, coherent internal business communications / reports and presents results of work
Willing and able to work under the pressure of deadlines and find solutions to meet timelines
Ability to work across teams by being a flexible team player with strong communication and interpersonal skills
Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and internet
Exceptional organizational and time-management skills. Ability to multi-task with a high degree of professionalism and diplomacy
Preferred
Experience in the life sciences industry is preferred
Experience with EHS programs is preferred
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
Company data provided by crunchbase