Sr. Clinical QA Manager

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and 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, our European headquarters is in Dublin, Ireland 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 uson LinkedIn and Instagram.

JOB SUMMARY:

The Senior Clinical QA Manager (GCP) will be responsible for the quality oversight of the GCP activities related to clinical trials sponsored by BioCryst Pharmaceuticals. The Sr. Clinical QA Manger performs day-to-day clinical quality operations and compliance activities to support success of the clinical studies. The primary responsibilities will be to ensure that clinical processes are conducted in accordance to BioCryst Standard Operating Procedures and applicable regulatory GCP requirements (US FDA, EMEA, ICH, PMDA and country specific requirement), along with current industry standards and practices. Additionally, the position will be responsible for executing quality plans to include external Clinical QA audits of investigators, essential documents, CROs/Vendors, as well as internal audits of Clinical Development systems and processes. The Sr. Clinical QA Manager will report to the Associate Director, Quality Assurance. The Sr. Clinical QA Manager will support global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for company. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Drives continuous improvement of the Clinical Quality Management Systems (CQMS) and processes
• Develops and implements Clinical QA plans for BioCryst clinical studies to meet GCP quality standards, policies, and procedures.
• Supports and provides leadership in clinical audit activities for both internal and external parties (e.g., third-party vendors, clinical sites, and collaborators) to ensure alignment with BioCryst standards, regulatory requirements, and quality expectations.
• Coordinates and participates in the evaluation and selection of external vendors, including supporting risk-based assessments in coordination with External Vendor Management and determining quality expectations for the vendors in clinical trials.
• Serve as the CQA SME for cross-functional team meetings with Clinical Development (Clinical Operations, Nonclinical, Data Management, Biostatistics, Pharmacovigilance, Legal and Regulatory Affairs) regarding clinical quality matters, providing regular updates on audit outcomes, CAPA effectiveness, and overall quality status of ongoing clinical trials.
• Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to Quality and Clinical Management.
• Works closely with Clinical Development to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary.
• Leads clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks.
• Works with Clinical staff to investigate temperature excursions, investigational product complaints and deviations reported from clinical sites.
• Maintains a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program.
• Conducts reviews of clinical and regulatory documents, ensuring quality, accuracy and completeness. Coordinates/ Conducts quality assurance review/audit of protocols, Clinical Study Reports, Investigator Brochures, and Integrated Summaries, etc.
• Plays a key role in preparing for regulatory inspections, acting as a subject matter expert for inspectors and ensuring the clinical operations team is fully prepared for interactions. Reviews and updates BioCryst SOPs, identifying the need for new SOPs, and developing new CQA SOPs as needed.
• Shares responsibility with the team for the development of training materials and conducting training.
• Supports GVP QA activities as part of R&D QA team. Participates in GVP QA cross training.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree preferably in a scientific area, with at least seven (7) years of clinical quality assurance experience and minimum of 3 years clinical auditing/oversight experience in the regulatory compliance environment. GLP bioanalytical and toxicology auditing experience a plus.
• Excellent communication and negotiation skills; maintains high ethical standards, and enjoy working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
• Adheres to ethical and good clinical practices and the ability to work as part of a team. As well as work independently in a remote workforce environment.
• Excellent organizational skills and ability to work on multiple projects with competitive timelines is required.
• Strong attention to detail and respect for the need of accuracy of information.
• Exceptional verbal, written, and interpersonal communication and presentation skills.
• Must be capable and willing to travel (up to 15%), including the potential for international travel.
• Must have a thorough understanding of applicable US and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits.
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
• Demonstrated ability to work effectively in cross functional team environment.
• Good 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.