Senior QA Lead, Biopharma Compliance & Validation

KBI Biopharma; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

KBI Biopharma is seeking a Principal QA Specialist to lead compliance review of GMP data, including in-process, release, and stability data. You will oversee analytical and microbial laboratory activities, ensuring patient safety and regulatory adherence while supporting product lifecycle activities for timely delivery to clients.

The role involves collaboration with manufacturing, QA batch disposition, and other stakeholders to maintain quality culture and support site goals.

Qualifications

• Bachelor’s degree and 10+ years' experience or Master’s degree and 6+ years' experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent.

Responsibilities

• Performs timely review of test data for in process, release, and stability samples. Assures activities comply with required procedures, cGLP, and cGMP requirements.
• Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities. Supports client audits and regulatory inspections as required. Other activities as assigned by Management.
• Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

Skills

Interpersonal skills

Attention to detail

Problem solving

Team collaboration

Education

Bachelor’s degree

Master’s degree

Tools

MS Office

LIMS

Databases

Spreadsheets

Outlook

Teams

Job description

KBI Biopharma is seeking a Principal QA Specialist to lead compliance review of GMP data, including in-process, release, and stability data. You will oversee analytical and microbial laboratory activities, ensuring patient safety and regulatory adherence while supporting product lifecycle activities for timely delivery to clients.

The role involves collaboration with manufacturing, QA batch disposition, and other stakeholders to maintain quality culture and support site goals.