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Clinical Quality Assurance
3 months ago
**About the Role**: We are looking for a Clinical Quality Assurance Professional to join our Clinical Quality Assurance (CQA) team. This role will globally assess processes and procedures, operations, and compliance to Good Clinical Practice (GCP) regulatory requirements/standards (ISO 14155, 21 CFR 50, 54, 56, 812, and ICH E6, etc.) and controlled documents.
This is a remote position, and you can work from home in most locations within the United States.
**Responsibilities**:
- Participate in setting up and maintaining quality systems that are compliant with applicable clinical regulations and standards. This includes assisting in the assessment, creation, and presentation of quality metrics within Clinical
- Provide compliance guidance and advice to Clinical Study Teams and Functional Groups throughout the clinical investigation life cycle
- Assess compliance of Sponsor/Investigator/Monitor/Vendor to the study protocol, ICH GCP guidelines and all applicable regulations. This includes the documentation/data that is generated, documented, and reported
- Plan, schedule, and conduct or oversee internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analyses of clinical trials. Document/review audit observations and responses; evaluate impact and make recommendations for improvement initiatives
- Support the Clinical vendor qualification, selection, and management process; participate in the assessment of Clinical Vendor systems compliance supporting clinical activities
- Provide compliance guidance and leadership for regulated activities including the preparation and coordination of inspections/audits by regulatory authorities for clinical trials and inspection readiness training for Clinical Study Teams
- Participate in problem-solving with Clinical Leadership, Clinical Study Teams, and Clinical Functional Teams
- Provide systems compliance oversight of computer systems implemented to support clinical activities. Participate in development of quality management system documentation related to computer systems/software use
- Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position. Advise leadership on the possible impacts of regulatory changes
**Required Qualifications**:
- Bachelor's degree and minimum 5 years of experience in the Medical Device industry; equivalent experience in Biotech, Pharmaceutical or Healthcare industries will be considered
- Minimum 3 years of experience in clinical quality system compliance and auditing in the Medical Device industry
- Strong working knowledge of Good Clinical Practices (GCP) and all applicable regulations
- Working knowledge of the clinical research lifecycle and Subject Data Protection regulations and laws
- Working knowledge of inspection management
- Demonstrated project management and influence skills
- Organizational skills, flexibility, and ability to multi-task
- Strong verbal and written communication skills
- Ability to travel up to 25%
**Desired Qualifications**:
Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
**What We Offer**: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
