Sr. Clinical QA Specialist

COMPANY:

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. 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 the Company’s website at www.biocryst.com.

JOB SUMMARY:

The Senior Clinical QA Specialist will be responsible for the development, maintenance, and oversight of the GCP activities related to clinical trials sponsored by BioCryst Pharmaceuticals. The primary responsibilities will be to ensure that clinical processes are conducted in accordance with 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. The Senior Clinical QA Specialist will report to the Sr. Manager, Clinical Quality Assurance. The Senior Clinical QA Specialist 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:

• Supports the GCP-related quality systems to ensure compliance with applicable regulatory requirements and best industry practice.
• Supports continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence.
• Performs routine and complex internal and external audits according to BioCryst’s procedures, regulations, and/or contracted CRO applicable procedures. These audit types include (not limited to) investigator site, Trial Master Files, Clinical Study Reports, other clinical study related documents, and systems/processes.
• Conducts auditing activities with minimal supervision of CQA Management and/or more experienced auditor.
• Performs routine and complex internal and external audits according to BioCryst’s procedures, regulations, and/or contracted CRO applicable procedures. These audit types include, but are not limited to, Investigator Site, Vendor, Phase 1 CRU, Trial Master File, System/Process, Clinical Study Report, and other clinical study related documents.
• Operational auditing activities include the planning of audits, ensuring the scheduling of audits, reporting of observations/findings, tracking and collection of reported responses and corrective actions and audit closure.
• Contribute to External Vendor Management of outsourced clinical vendor audits by providing quality assurance expertise in the review of agendas, reports, responses to audit observations and evaluations for qualification.
• Participates in meetings to discuss audit findings as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes.
• Maintains databases for Clinical QA audit observations and CAPAs; Track, review, approve, and assess the adequacy of CAPAs.
• Represents Clinical Quality Assurance on key sponsor and study project teams including dissemination of key quality information, guidance, training, and support.
• Reviews clinical documents, ensuring quality, accuracy, and completeness including protocols, clinical study plans, clinical study reports and notes to file.
• Works with Clinical staff to investigate temperature excursions, IMP product complaints reported from clinical sites. Assists with archive process for off-site storage as needed.
• Works closely with Clinical Operations to ensure 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.
• 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 Clinical Quality management.
• Assists with the preparation, coordination, and management of regulatory agency inspections.
• Reviews and updates CQA SOPs and assists as needed to develop/review new SOPs.
• Shares responsibility with the team for the development of training materials and conducting training.
• Must have a thorough understanding of applicable US and international regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits.
• Appropriate technical skills in the compliance disciplines e.g., GCP/ICH.
• Be able to interact effectively in a team-based environment.

EXPERIENCE & QUALIFICATIONS:

• Minimum BS degree, preferably in a scientific area. Minimum of five (5) years of pharmaceutical and clinical quality assurance auditing and oversight experience in the regulatory compliance environment.
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
• Maintain a thorough understanding of applicable US and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits (experience preferred).
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
• Demonstrated ability to work effectively in cross functional team 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 occasionally (up to 15%), including the potential for international travel.
• Good problem-solving and decision-making skills.
• 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.

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.