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 - Senior Director, Clinical Quality Assurance!
- 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
- You will partner with the Project Management, Medical, Clinical, Regulatory and IT Leadership and the Study Execution Team members to provide GCP/GVP support for clinical studies
- You are responsible for leading the Clinical Quality (CQA) function of Biorasi focused on the oversight of the company’s and clinical trial compliance with applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs and GVP).
- You take care for developing and implementing strategy, policies, procedures, methodologies, tools for managing CQA processes and employees.
- You lead the Clinical Quality (CQA) function of Biorasi focused on the oversight of the company’s and clinical trial compliance with applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs).
- You serve as an GCP / GPV SME and mentor to the CQA, service delivery and non-delivery staff in interpretation of regulations/guidelines, as they apply Biorasi and its clinical trials.
- In coordination with the commercial, service-delivery and financial functions oversees the CQA resource allocation and planning by developing, reviewing and approving CQA -related project study budgets, work breakdown structure, project schedule and overall budget
- You select, allocate, and manage CQA team resources across projects.
- You represent CQA during regulatory inspections, and support preparation and hosting of third party audits and inspections, including, but not limited to regulatory agencies, sponsor, certification bodies, and business partner
- You demonstrate effective leadership and working skill in teamwork, delegation, organization, and coordination.
- You represent Biorasi as needed for outside events, sponsor meetings, public speaking, and in the general business community.
- Bachelors or advanced degree in science, business, or legal
- Approximately 10 years of clinical research experience in CRO industry and GCP/GPV quality assurance practice
- Expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and international regulations
- Extensive knowledge of FDA and EMA 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; Prior management experience required
- Excellent verbal, written communication, and presentation skills
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.