Director, Quality Control — Remote & Analytical Excellence

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a Director of Quality Control to provide strategic and operational oversight of QC activities across small molecule, biologic, and device programs. You will lead analytical control strategies, method performance, reference standards, and investigations, ensuring compliance with global GxP standards and internal systems.

You will partner with Analytical Development, QA GMP Operations, Regulatory Affairs, and CMOs to align analytical control strategies from

Qualifications

• Advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related discipline.
• Minimum twelve (12) years of pharmaceutical/biotechnology quality experience.
• Experience with QC/QA oversight and analytical sciences in drug development and manufacturing.
• Strong knowledge of FDA/EMA ICH GMP globally and regulatory expectations.

Responsibilities

• Provide governance for QC activities across raw material, in-process, release, stability, and testing.
• Ensure QC labs operate in compliance with regulations and internal standards.
• Act as primary Quality escalation point for QC-related issues.
• Oversee investigations, CAPAs, and data integrity with scientifically sound justifications.
• Lead lifecycle management of reference standards, reagents, and analytical controls.
• Oversee global stability program design, data review, and regulatory support.
• Support regulatory submissions and audits; liaise with QA, Regulatory, and external labs.

Skills

Quality oversight

Regulatory knowledge

Leadership

Analytical thinking

Education

MS/PhD preferred

Job description

BioCryst Pharmaceuticals seeks a Director of Quality Control to provide strategic and operational oversight of QC activities across small molecule, biologic, and device programs. You will lead analytical control strategies, method performance, reference standards, and investigations, ensuring compliance with global GxP standards and internal systems.

You will partner with Analytical Development, QA GMP Operations, Regulatory Affairs, and CMOs to align analytical control strategies from