KBI Biopharma · 1 day ago
Manager/Senior Manager, QA Analytical
Durham, NC
Full-time
Onsite
Senior Level
6+ years expKBI Biopharma is a global contract development and manufacturing organization providing integrated drug development and biologics manufacturing services. The role involves managing the QA Analytical function, overseeing laboratory operations, and ensuring compliance with GMP testing protocols.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
Leads and directs the QA Analytical team supporting analytical testing operations
Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities
Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents
Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing
Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required
Qualification
Required
BS in scientific field with 8+ years' experience or MS and 6+ years' experience in a QA or GMP environment or equivalent
Experience in a QA role supporting GMP analytical testing
Minimum of 2 years of supervisory experience
Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs
Knowledge of US, EU and Row cGMP guidelines
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Basic math skills
Ability to apply concepts of basic algebra and statistics
Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables
Knowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management
Knowledge of and experience using a computer, a telephone
Preferred
Experience with electronic laboratory information management systems
Benefits
Annual bonus structure for all employees
Medical, dental, and vision coverage
Paid PTO and holidays
401K matching
Employee recognition programs
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
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2025-11-14
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