What Quality & Regulatory Audit contributes to Cardinal Health
Responsible for independent (with supervisory assistance as needed) planning, scheduling, and conducting Clinical QA inspections/audits/reviews to assure compliance with regulatory requirements and adherence to corporate policies, and internal standards/requirements.
Applies intensive and diversified knowledge of pre-clinical, biomedical monitoring and clinical trials principles and practices in broad areas of assignments and related fields
Makes decisions independently on biomedical monitoring problems and methods, and represents the organization in meetings to resolve important questions and to plan and coordinate work
Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines
Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters
Consults with supervisor concerning unusual problems and developments
Responsible for or more of the following:
Plans, develops, coordinates, and directs a large important biomedical monitoring / clinical trial project or a number of small projects with many complex features
As an individual contributor, carries out complex or novel assignments requiring the development of new or improved techniques or procedures
Work is expected to result in the development of new or improved techniques or procedures.
Work is expected to result in the development of new or refined materials, processes, and/or methods
Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others
Assesses the feasibility and soundness of proposed clinical studies
Performs as a Lead Auditor to facilitate and manage Franchise pre-clinical and biomedical research monitoring audit programs, including but not limited to, audits of the clinical affairs department, audits of clinical trial program suppliers, Principal Investigators, animal laboratories, Contract Research Organizations and software providers
Facilitates and manages external and internal inspections as they are related to the Franchise Biomedical Monitoring and Pre-Clinical programs and Clinical Affairs. May perform as a scribe, back room manager, request administrator or other critical roles in an inspection.
Serves as biomedical monitoring compliance and pre-clinical lead for the Franchise and ensures department metrics are monitored to ensure goals are met. Manages Franchise Pre-Clinical and Biomedical Monitoring programs.
Performs as a staff consultant on a technical specialty, a type of facility or equipment, or a program function
Practices company safety and quality policies and procedures. Actively requires conformance.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
Responds to compliance inquiries from the applicable peer department with supervisory assistance as needed.
Keeps abreast of new regulations/requirements through active review of current compliance-based literature.
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
EDUCATION/TRAINING and/or EXPERIENCE:
BS degree in relevant discipline and four or more years of related pre-clinical, biomedical monitoring, clinical quality, clinical affairs, quality compliance or quality systems experience; or
MS in relevant discipline and three or more years of related pre-clinical, biomedical monitoring, clinical quality, clinical affairs, quality compliance or quality systems experience; or
Has significant complex level clinical quality, clinical affairs, pre-clinical or biomedical monitoring experience
Must possess at least five years experience within the medical product industry, preferably medical or combination devices
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
Must possess significant level of knowledge regarding global medical device regulations (CMDCAS, 21CFR Part 820, RDC, JPAL, MDD, ISO 13485) and global clinical trial regulations (Declaration of Helsinki, 21CFR Parts 11, 50, 56, 58, 312, 812, 45 CFR Part 46, ICH GCP-E6, ICH–E2A)
Must effective in English communication skills, both written and oral
Lead Auditor Certification or training is highly desired
ASQ certifications in auditing and/or biomedical auditing is highly desired
Certification as a Clinical Research Associate (CRA) is highly desired
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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My work is very analytical, and it’s very satisfying sifting through the layers of information to solve challenges. It can be time consuming, but that moment of finding what’s holding an order up is worth the effort.
I also enjoy being a representative of Cardinal Health and building rapport and trust with our customers.
Patricia, Collections Coordinator