COMPANY:
At BioCryst, 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 our website at www.biocryst.com or follow us on LinkedIn and Instagram.
JOB SUMMARY:
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.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- 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 that stability studies support regulatory filings, shelf‑life assignments, and ongoing product verification.
- Provide oversight for annual product quality reviews associated with QC data (e.g. 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 rationale, while verifying specifications are scientifically justified, phase‑appropriate, and aligned with regulatory commitments.
- Partner with Regulatory Affairs to support specification‑related regulatory submissions and variations.
- Provide Quality and technical oversight of analytical method validation, verification, lifecycle management, and method transfers in close collaboration with Analytical Development, including review of validation design, acceptance criteria, and method performance trends. Ensure methods are robust, controlled and compliant across external testing sites.
- Lead and/or support Quality Assurance (QA) audits and regulatory inspections of QC laboratories,serving as a Quality SME. Confirm inspection observations, audit findings and regulatory commitments are effectively addressed and sustained.
- Ensure QC‑related processes are appropriately defined within the Quality Management System (QMS), including SOPs, training, change control, and risk management.
- Drive continuous improvement initiatives across QC processes, analytical efficiency, and compliance maturity.
- Contribute QC metrics, trends, and risk assessments to Quality Management Review (QMR) and Quality Council forums.
- Provide functional leadership, mentoring, and development for QA staff supporting QC oversight.
- Support selection, qualification, and ongoing oversight of external QC laboratories and CMOs.
EXPERIENCE & QUALIFICATIONS:
- Advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related scientific discipline (MS/PhD preferred).
- Minimum twelve (12) years of pharmaceutical/biotechnology quality experience, including significant experience in QC, QA oversight of QC, and/or analytical sciences.
- Demonstrated experience supporting small molecule, biologics, and/or combination device programs.
- Strong working knowledge of FDA, EMA, ICH and EU GMP and global regulatory expectations for laboratory operations.
- Proven experience supporting regulatory inspections and managing complex QC‑related compliance issues. Strong understanding and ability to implement risk management fundamentals/tools.
- Experience with statistical analysis of analytical data and method capability with strong scientific and analytical judgment.
- Deep understanding of laboratory investigations and data integrity.
- Demonstrated ability to apply scientific judgment to analytical data interpretation, method performance issues, and complex laboratory investigations.
- Excellent organizational skills and ability to work on multiple projects with competitive timelines is required.
- Excellent communication, negotiation, and presentation skills; maintains high ethical standards, and enjoys working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
- Demonstrated ability to work effectively in cross functional team environment and independently in a remote work setting, as necessary.
- Excellent problem-solving and decision-making skills.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.