Director, Clinical Quality Assurance

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.

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.

Your role:

• Lead the Clinical Quality Assurance (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).
• Under general guidance from S(VP) Quality develops strategy, policies, procedures, methodologies, tools for managing CQA processes and employees.
• Member of extended Senior Leadership Team representing CQA and contributing to the strategic and tactical discussions related to daily activities, issues of escalation, resources, time allocation and performance metrics.
• Provide consultation to the Service delivery and non-delivery branches and staff in interpretation of regulations/guidelines, as they apply Biorasi and its clinical trials.
• Ensure that Biorasi standard operating procedures (SOPs), processes, and procedures are compliant with applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs).
• Serve as an SME for areas of responsibility during regulatory inspections, and support preparation and hosting of 3^rd party audits and inspections, including, but not limited to regulatory agencies, sponsor, certification bodies, and business partners.
• Establish, maintain, lead, carry out internal project-focused QA audit plans and study audits; Corrective and Preventive (CAPAs), quality risk management and indicators, and on-going oversight and communication with the key study operational and support personnel. Ensure that deficiencies, deviations, and quality and compliance risks are detected and mitigated in a timely / prompt manner.
• In partnership with Regulatory Affairs, and Quality Management, keep abreast of industry developments – forthcoming regulations, guidance, best practices; provide expert and practical guidance and advise to company, regional management, and sponsors partners on the laws, regulations, and industry best practices that are applicable to the clinical trials.
• In partnership with Human Resources, Learning and Development functions, and Quality Management, lead the update, development, and delivery of training and other programs related to applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs).
• In coordination with the Commercial, Project Management, and Finance Branches 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 in coordination. Select, allocate, and manage CQA team resources across projects.
• Champion and support Biorasi-wide strategic quality improvement initiatives related to people, process, and technology, as assigned. Support and collaborate with Process Agility, and Quality Management functions on implementation the quality management processes and initiatives.
• Adhere to applicable national and international laws, regulations, and guidance (or sections thereof) governing clinical trials, including, but not limited to applicable the Good Clinical Practices (GCPs).
• Comply with Biorasi policies, standard operating procedures (SOPs), operating guidelines, and other written instructions.
• Demonstrate effective leadership and working skill in teamwork, delegation, organization and coordination.
• Promote and support Biorasi values and culture of quality, collaboration, mutual respect, and trust among the staff and functions.
• Represent Biorasi as needed for outside events, sponsor meetings, public speaking, and in the general business community.
• Other duties and initiatives, as assigned.

Your Profile:

• Degree in science, related scientific discipline, or business. Bachelor's degree, Master's degree preferred.
• Ability to travel 25% of the time.
• Fluent English (oral and written).
• 10+ years in drug development or clinical research within the pharmaceutical industry with 3 years in quality assurance, quality management experience.
• Proven ability to manage and develop people.
• Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize.
• Knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements.
• Excellent verbal, written communication, and presentation skills.
• Computer literacy.

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 or email us at careers@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 half-day Fridays, paid time off, paid holidays, extensive country specific benefits, 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.