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Schedule: Full-timeAbout Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
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 and controlled documents.
This is a remote position, and you can work from home in most locations within the United States.
- 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
- Assess compliance of Sponsor/Investigator/Monitor/Vendor to the protocol, ICH GCP (International Conference on Harmonization Good Clinical Practice) 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
- 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
- Provide compliance guidance and leadership for regulated activities including the preparation and coordination of inspections/audits by regulatory authorities for clinical trials; provide inspection readiness training for Clinical Study teams
- Participate in problem-solving with Clinical Leadership, Clinical Study teams, and Clinical Functional teams
- Participate in the assessment of Clinical Vendor systems compliance supporting clinical activities
- Provide compliance guidance and advice to Clinical Study teams and functional groups
- 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 ramifications of regulatory changes
Required Qualifications:
- Bachelor's degree
- Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
- Minimum of 2 years experience in clinical and/or quality system compliance and auditing
- Knowledge of Good Clinical Practices (GCP) and all applicable regulations
- Knowledge of the clinical research lifecycle and Subject Data Protection regulations and laws
- Working knowledge of inspection management
- Demonstrated project management and leadership skills
- Organizational skills, flexibility, and ability to multi-task
- Strong verbal and written communication skills
- Ability to travel up to 25%, as necessary, to achieve business and project objectives
Desired Qualifications:
- Knowledge in 21CFR Part 11 and application of predicate rules with respect to clinical processes and systems
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: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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