Quality Systems Consultant

Codon Partners is seeking a Quality Systems Consultant to join their team in Durham, Durham County, supporting a fast‑growing biotechnology client that develops cell and gene therapy platforms.

About the Role

As a Quality Systems Consultant, you will partner with the client’s leadership to design, implement, and maintain quality management frameworks that align with GMP expectations and regulatory standards for advanced therapeutics.

What You'll Do

• Assess existing quality processes and identify gaps relative to FDA, EMA, and ISO 13485 requirements for cell and gene therapy manufacturing.
• Develop standard operating procedures, work instructions, and batch records that support IND‑enabling studies and early‑phase clinical trials.
• Guide the implementation of change control, deviation investigation, and CAPA systems to ensure continuous improvement.
• Provide training to manufacturing, QC, and QA staff on quality policies and documentation practices.
• Support audit readiness by preparing for internal and external inspections, including pre‑IND meetings.
• Collaborate with process development and regulatory affairs teams to embed quality considerations into product lifecycle decisions.

What We're Looking For

• Bachelor’s degree in life sciences, engineering, or a related field; advanced degree or certifications (e.g., ASQ CQA, RAC) preferred.
• Minimum 5 years of experience in quality assurance or quality systems within biologics, gene therapy, or cell therapy environments.
• Deep knowledge of cGMP, 21 CFR Part 210/211, ISO 13485, and ICH Q7/Q10 guidelines.
• Proven ability to author and review SOPs, batch records, and quality agreements for early‑stage clinical material.
• Strong interpersonal skills to influence cross‑functional teams and facilitate training sessions.
• Experience with electronic quality management systems (EQMS) and familiarity with risk‑based approaches such as FMEA.

About Codon Partners

Codon Partners specializes in connecting life‑science innovators with expert talent that accelerates product development. We work with emerging biotech firms in the Research Triangle region to build robust quality, regulatory, and manufacturing foundations that support successful IND filings and commercial scale‑up.

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