BioCryst Pharmaceuticals, Inc.
Director, Quality Control
US_North Carolina_Remote, USA · Director
Sponsorship not specifiedDetected 85 days ago
StatisticsProduct ManagementNegotiationGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsGxPRegulatory Affairs
About the role
- 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.
Responsibilities
- 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.
- 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.
- 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.
Requirements
- Minimum twelve (12) years of pharmaceutical/biotechnology quality experience, including significant experience in QC, QA oversight of QC, and/or analytical sciences.
- 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.
- 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.
- They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.
- Demonstrated experience supporting small molecule, biologics, and/or combination device programs.
- Proven experience supporting regulatory inspections and managing complex QC‑related compliance issues. Strong understanding and ability to implement risk management fundamentals/tools.
- Deep understanding of laboratory investigations and data integrity.
- 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.
Nice to have
- Advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related scientific discipline (MS/PhD preferred).
Compensation
- Provide oversight for annual product quality reviews associated with QC data (e.g. OOS/OOT trends, stability data, CoAs/QC release testing).
Company info
- 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.
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.
- 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.
Apply directly at BioCryst Pharmaceuticals, Inc. →Create a free account for alerts like thisView BioCryst Pharmaceuticals, Inc. immigration profile
This listing is sourced directly from BioCryst Pharmaceuticals, Inc.'s careers page and normalized into a canonical job model.