We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity - Director, Audits and Inspections! This is a remote based position located anywhere within the United States.

Overview

• We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India and Ukraine.
• Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
• Development and worklife balance: We want our employees to develop personally as well as professionally

Your Responsibilities

• Developing and implementing plans, methodologies, and tools for a proactive assessment of Biorasi GCP/GVP/ISO9001 compliance.
• Leading, conducting and reporting the results of the internal and vendor GCP/GVP/ISO9001 audits of Biorasi Quality Management System, processes, and clinical studies.
• Collaborating Biorasi Operational, Medical, and administrative function on identifying and managing quality and compliance risks, and opportunities for quality initiatives.
• Providing subject matter expertise and consultation in interpretation of applicable regulations, policies, and procedures aimed at implementing durable CAPAs.
• Coordinating and hosting 3rd party audits and inspections.
• Developing and presenting educational programs and providing guidance to operational staff on compliance procedures.

Your Profile

• Bachelors or advanced degree in science, business, or legal.
• 5+ years in clinical research within the biopharmaceutical or CRO industry.
• 5+ years GCP/GPV/ISO9001 Quality Auditing experience.
• Extensive knowledge of US FDA and international regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize. Ability to make timely, compliant and practical quality decisions when faced with complex clinical, compliance, technical and regulatory considerations.
• Effective leadership and collaboration, delegation, organization and coordination. Proven ability to motivate, influence, and develop people at all organizational levels.
• Experience in the conduct and reporting of audits for Phase I to Phase IV studies (e.g., investigator sites, eTMF, database, Clinical Study Report, process, third-party vendor), as well as hosting 3rd party inspections.
• Excellent verbal, written communication, and presentation skills.
• Up to 25% USA and international travel.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off to include vacation, holidays, and sick days, medical, dental, vision, life insurance, short-term and long-term disability, company matching 401K, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and 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 or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.