KBI Biopharma · 23 hours ago
Sr. Director, Quality
Durham, NC
Full-time
Onsite
Director/Executive
8+ years expKBI Biopharma is a contract manufacturer of microbial fermentation and mammalian cell culture protein therapeutics. They are seeking a Senior Director of Quality to lead the Quality Assurance and Quality Control team, ensuring compliance with quality systems and regulatory standards while collaborating with site operations for overall success.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives
Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities
Key contributor to long term strategic planning and part of senior leadership team
Work with internal and client teams to establish Quality strategy, define roles, and problem solve
Qualification
Required
Bachelor of Science degree in a scientific discipline
8 years of quality management experience
At least 5 years' experience serving in a relevant technical management capacity
At least 15 years of regulated pharmaceutical industry experience
Thorough knowledge of cGMPs and biotechnology-derived product regulations
Demonstrated track record in Regulatory Inspection management
Strong orientation for Quality and Customer Service
Strong collaboration and team building skills
Demonstrated level of respect for individuals
High level of integrity and personal responsibility
Record of innovation
Experience developing, implementing, and executing strategic plans and objectives for organizations and departments
Ability to read, analyze, and interpret the most complex documents
Ability to respond effectively to the most sensitive inquiries or complaints
Ability to write speeches and articles using original or innovative techniques or style
Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management peer group, employee groups, customers, and/or the boards of directors
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
Ability to understand and interpret nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases
Ability to deal with a variety of abstract and concrete variables
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
Ability to sit or stand for long periods of time
Ability to use a computer, telephone, spreadsheets, PowerPoint, Outlook
Preferred
Master's degree with 6 years of quality experience
PhD with 4 years of quality experience
CMO experience
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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