Overview
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines. This role supports the overall quality program and serves as a liaison between the Regulatory Affairs/Quality team and other service lines of Versiti. He/she/they partners with service lines to provide regulatory affairs input on projects and everyday tasks.
Total Rewards Package
CompensationThe target salary for this position is $83,745 annually.The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.BenefitsVersiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
- Core Quality Responsibilities * Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. * Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions. * May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for regulatory affairs, as required. * Reviews regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management. * Participates and may lead in the development, compilation, and submission of regulatory submissions as required. * May review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions. * Completes the review of events to assess impact. * Acts a resource for regulatory and quality matters.
- Specific Senior Regulatory Affairs (RA) Specialist Responsibilities * Authors and prepares documentation for regulatory submissions * Provides internal and external regulatory guidance and development of regulatory strategies * Maintains awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation * Maintains facility registrations for Versiti * Review documentation and make determination of submission to regulatory agencies, as applicable * Coordinates and consults with other functions on the content and assembly of regulatory documentation and ensures consistency, completeness, and adherence to standards for all the regulatory submission * Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed * Leads and tracks regulatory projects * Support junior-level RA Specialists in project execution and/or day-to-day RA tasks
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
Education
- Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required
- Master's Degree preferred
Experience
- 4-6 years of experience in related field required
- 4-6 years of experience with a master's degree required
- Experience in Regulatory Submissions and facility registrations required
- Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred
Knowledge, Skills and Abilities
- Advanced knowledge of the principles and practices within Regulatory Affairs (requiring academic preparation and experience)
- An experienced professional qualified in Regulatory Affairs, and possess experience in other complex technical area(s)
- Requires advanced knowledge and application of external standards and regulations that impact related disciplines.
- Determines and implements a course of action based on regulations, standards, and guidelines, and may modify processes and methods as required
- Requires knowledge of company policies, practices, and procedures or ability to quickly gain applicable knowledge
- Require knowledge and application of external standards and regulations.
- Ability to use professional concepts and company's policies and procedures to solve a variety of problems
- Strong written communication and business acumen skills
- Proficiency in Microsoft Office
- Possess strong attention to detail
- Ability to read, interpret and disseminate applicable regulations and standards
- Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred
Licenses and Certifications
- Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, RAPS RAC) preferred
Tools and Technology
- Personal Computer (desktop, laptop, tablet) required
- General office equipment (computer, printer, fax, copy machine) required
- Microsoft Suite (Word, Excel, PowerPoint) required
- Gap Assessment Tools for Standards/Regulations required
