Clinical Trials Quality Assurance Specialist
Vyriad is a clinical stage biotechnology company focused on curing cancer using potent, safe and cost effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery and fun.
The Clinical Trials Quality Assurance Specialist is responsible for oversight of quality and regulatory compliance for clinical trials activities. QA staff work to identify and reduce regulatory and compliance risk by continuously monitoring and evaluating policies and practices to ensure compliance is built into the operational programs. The Clinical Trials Quality Assurance Specialist is responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages all clinical related quality assurance activities and communicates with leadership to take necessary actions to mitigate identified risks.
Ensure clinical trials activities are conducted in compliance with regulations.
- Ensures that all processes contributing to the performance of a clinical trial are conducted in compliance with regulations and internal quality management system policies and procedures.
- Troubleshoots clinical trials and activities and provide risk mitigation strategies.
- Manages and maintains databases for the quality system.
- Prepares and assists in preparing annual reports and quality trending reports.
- Assists with the preparation and compilation of materials for submission to regulatory agencies.
Coordinates implementation and maintenance of quality and compliance practices for the clinical program.
- Establishes strategic direction and prioritization on quality and compliance initiatives. Ensures the quality and compliance strategic planning activities are aligned with facility vision, mission, and objectives.
- Advises clinical staff in the review and interpretation of regulatory requirements impacting them and advises on necessary compliance actions.
- Participates in the development and review of protocols, processes, and product specifications to ensure compliance with regulatory and quality requirements.
- Educates leadership and operational personnel to ensure the regulatory requirements are understood at the level necessary to execute defined functions, including risks of non-compliance.
- Participates in the preparation of regulatory filings (IND, TMF, NDA’s, annual updates).
- Establishes strategic direction and prioritization on quality initiatives. Ensures the quality strategic planning activities are aligned with facility vision, mission, and objectives.
- Manage activities to ensure Quality Management System (QMS) are appropriately implemented. Authors/approves policies and procedures to define and support processes ensuring adherence to quality system requirements.
- Evaluates quality risks and makes recommendations to leadership. Ensures quality concerns are prioritized and resources for support are identified.
- Establishes systems to collate and review quality metrics and ensures information is reviewed by executive leadership/management.
- Participates in annual planning for quality initiatives.
- Provides support as needed for on-site assessments.
- Reviews corrective action plans for deficiencies cited in assessments; ensures responses adequately address citations and requirements; reviews and endorses responses.
- Performs audits and gap analyses against regulatory and internal requirements. Effectively documents and communicates non-compliance issues and observations.
- Prepares assessment reports that are concise and customer focused.
- Assists in the collection, analysis and interpretation of monitoring data for regulatory issues (using statistical tools and graphs). Determines if, or recommends when, process improvements are needed.
Leads process improvement activities for the clinical program.
- Identifies potential improvements and leads process improvement teams as needed.
- Facilitates the documentation, design and implementation of new and changed processes.
- Assists with the application of quality management tools for measuring improvements.
- Continually expands knowledge of quality management and regulatory principles.
- Serves as a resource and mentor in quality principles and regulatory requirements.
- A bachelor’s degree in a science related field is required.
Experience and/or Qualifications
- Relevant: Research or analytical. Experience with cGMP production highly desirable.
- A minimum of 5 years’ experience required in a quality assurance and/or regulatory affairs role in an FDA regulated role with clinical trials operation and management.
- Knowledge and experience in FDA Good Clinical Practices and ICH requirements is required.
- Additional experience with other requirements (Good Manufacturing Practices, Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional human relations and communication (written, verbal, and listening) skills are required.
- Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role.
- Must have demonstrated capacity to comprehend complex protocols, programs, and situations.
- The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Rochester, MN (Required)
United States (Required)
- Health Insurance
- Dental Insurance
- Vision Insurance
- Long/Short-Term Disability Insurance
- Paid time off 15 days with 6 company holidays
- Simple IRA
How to apply
To apply please send a resume and cover letter to firstname.lastname@example.org. References will be requested and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Vyriad is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.