KBI Biopharma · 7 hours ago
Principal QA Specialist
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expKBI Biopharma is a company focused on ensuring compliance in the pharmaceutical industry, and they are seeking a Principal QA Specialist. This role involves acting as a client liaison, overseeing quality metrics, and supporting product release processes while ensuring adherence to regulatory requirements and internal quality standards.
BiotechnologyHealthcarePharmaceuticalManufacturingBiopharmaHealth Care
Responsibilities
Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline
Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed
Routinely interfaces with the PMO team to ensure any Quality topics are addressed
Serves as QA facilitator for the Quality aspect of all projects requiring QA support. Serves as the accountable Quality lead, decision maker, and delegate for project teams and in related meetings
Supports audit / inspection readiness of the site. Participates in regulatory and other quality and compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned
Serves as client liaison and quality representative on behalf of KBI in audits, client and other client facing meetings and those requiring a Quality SME where the job skills and proficiencies allow
Supports Deviation Management activities by participating in investigational meetings, activities, writing as needed, and approving investigations. Leads Product and Client Complaint activities in accordance with SOP and established requirements
Supports efforts to ensure organization operates within established policies/procedures and complies with all applicable governmental regulations (cGMP, etc.), both domestic and foreign
Operates in a safe and efficient manner and in compliance with the safety and health policy
Qualification
Required
BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 7-10 years of relevant experience as described below
Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements
Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role
Demonstrates solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles
Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results
Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people
Demonstrated ability to keep Project Leads, such as PMs and team members informed of the status of assigned work
Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently
Demonstrated strong attention to detail and effective investigation, problem solving and organizational skills
Ability to properly prioritize tasks, manage time effectively
Preferred
Project Management experience or formal training is a plus
Prior direct regulatory agency, and audit management /r support experience a plus
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
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