Clinical QA Manager
Durham, United States
Posted on: April 17, 2021
Closing: May 17, 2021
Position Type: Full Time
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.
The Clinical QA Manager (GCP) 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 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. The Clinical QA Manager will report to the Director, Quality Assurance. The 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.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures.
- Leads or Manages the oversight of domestic and international investigator site audits, Trial Master Files, Clinical vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH and BioCryst policies and procedures.
- Communicates Investigator Site and Clinical Vendor audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes.
- Maintains databases for Investigator Site audit observations and CAPAs; Tracks, reviews, approves, and assesses the adequacy of CAPAs. Provides input and supports observation and CAPA tracking for external Clinical vendors.
- Participates in the evaluation and qualification of CROs and other clinical vendors/ suppliers in coordination with External Vendor Management. Supports the Clinical Vendor audit management function and the supporting processes, procedures and tracking related activities, including external compliance and audit support of CROs, specialty laboratories and Phase I units.
- 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.
- Performs program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.
- Attends cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management.
- Conducts internal audits (systems, processes, vendors, computer system validation)
- Conducts reviews of clinical and regulatory documents, ensuring quality, accuracy and completeness. May conduct quality assurance review/audit of protocols, Clinical Study Reports, Investigator Brochures, and Integrated Summaries, etc.
- Assists with the preparation, coordination, and management of regulatory agency inspections.
- 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.
- Works with Clinical staff to investigate temperature excursions, product complaints and deviations reported from clinical sites.
- Participate in the budget planning process for Quality Assurance
- All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
- BS degree required, preferably in a scientific area.
- Minimum of at least five (5) years of clinical quality assurance experience and a minimum of 3 years clinical auditing/oversight experience in the regulatory compliance environment or an equivalent combination of education and experience.
- 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.
Posted on: April 17, 2021
Closing: May 17, 2021
Position Type: Full Time