Director, Quality Control

COMPANY

At Bio Cryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives.

For more information, please visit  or follow us on Linked In and Instagram.

The Director, Quality Control (QC) is responsible for providing strategic and operational quality oversight of all Quality Control (QC) activities supporting the development, manufacture, testing, release, and lifecycle management of small molecule, large molecule/biologic, and combination products. The Director, Quality Control provides technical leadership and scientific decision making for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations, serving as a recognized technical authority for QC‑related matters across the product lifecycle.

This role ensures QC activities are executed in compliance with global GxP regulations and internal Quality Systems. The Director serves as the primary Quality authority for QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance, and partners closely with Analytical Development to ensure effective method design, lifecycle transfer, performance characterization, and alignment of analytical control strategies from early development through commercialization.

The role also partners closely with QA GMP Operations, Global Technical Operations, Regulatory Affairs, and external testing laboratories/CMOs.

• Provide quality and technical oversight and governance for all QC activities including raw material, in-process, release, stability, and special testing for drug substance, drug product, and combination devices.
• Ensure QC laboratories/operations operate in compliance with applicable regulations and internal standards.
• Act as the primary Quality escalation point for critical QC‑related quality and compliance issues.
• Provide quality oversight and approval of Laboratory Investigations, including OOS, OOT, atypical results, deviations, and data integrity events, ensuring investigations are scientifically sound, risk‑based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure.
• Trend QC events and ensure systemic issues are identified and addressed.
• Establish and maintain lifecycle management for reference standards and critical reagents, partnering with Analytical Development to define qualification strategies, potency assignment and requalification approaches, while ensuring consistent implementation across internal QC labs and external testing partners.
• Provide Quality oversight and lifecycle management of the global stability program, including protocol design input and approval, execution oversight, data review and interpretation, trend analysis, and reporting while ensuring stability studies support regulatory filings, shelf‑life assignments, and ongoing product verification.
• Provide oversight for annual product quality reviews associated with QC data (OOS/OOT trends, stability data, CoAs/QC release testing).
• Ensure robust processes for CoA generation, review, and approval processes for clinical and commercial materials ensuring analytical data integrity, specification compliance, and alignment with regulatory filings.
• Oversee specification management, including establishment, review, approval, and lifecycle maintenance for drug substance, drug product, and combination devices in collaboration with Pharmaceutical Sciences. Ensure alignment on scientific justification and regulatory…