Clinical QA Manager
Job Title: Clinical QA Manager
Department: Quality Assurance/ Regulatory Affairs
Location: Durham, NC
The Clinical QA Manager (GCP) will be responsible for QA oversight of the BioCryst clinical development activities and commercial products. This position will ensure clinical processes are conducted in accordance with BioCryst SOPs and GCP guidelines and regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Clinical QA Manager will be responsible for establishing and maintaining the GCP audit management function and the supporting processes, procedures, and tracking. Coordinate regularly with, Clinical Operations, Project Management, Regulatory Operations, as required to establish and manage annual global GCP compliance activities including internal process audits and project-related audits. This individual will have the proven ability to adhere to ethical and good clinical practices and the ability to work as part of a team.
Specifically, the position will:
- Develop and execute Clinical QA plans to meet regulatory compliance goals
- Perform or coordinate domestic and international audits of investigator sites, documents, databases, vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH and BioCryst policies and procedures
- Communicate 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
- Maintain databases for audit observations and CAPAs; Track, review, approve, and assess the adequacy of CAPAs
- Conduct audits of clinical and regulatory documents, ensuring the quality, accuracy and completeness of various documents, including but not limited to Trial Master Files, Clinical Study Reports, Investigator Brochures, and Integrated Summaries.
- Participate in the evaluation and qualification of CROs and other service providers
- Assist with the preparation, coordination, and management of regulatory agency inspections
- Review and update CQA SOPs, identifying the need new CQA SOPs, and developing new CQA SOPs as needed
- Share responsibility with the team for the development of training materials and conducting training
- Work with Clinical staff to investigate temperature excursions, product complaints and deviations reported from clinical sites. Maintain deviation database.
- Assist with archive process for off-site storage
- Must be capable and willing to travel (up to 30%), including international travel
- 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.
- Computer skills and understanding are necessary
- Appropriate technical skills in the compliance disciplines e.g., GCP/ICH
- Be able to interact effectively in a team-based environment
BS degree, preferably in a scientific area, with at least seven (7) years of industry experience and 3+ years auditing experience in the regulatory compliance environment.
Distinguishing Characteristics of this Level
Clinical QA Manager (GCP) must have excellent communication and negotiation skills, maintain high ethical standards, and enjoy working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
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 (oral and written).
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 laws.
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.