Manager, 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, 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- Manager, Clinical Quality Assurance, in India (Remote Position)!

Overview

• We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, 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

• Preparation, hosting/supporting, follow-up and closure of client audits.
• Participates in and supports conduct and follow-up of regulatory authority inspections of Biorasi, Biorasi clients and Investigator Sites managed by Biorasi as required
• Ensure all relevant records and information are available and QC’d prior to the audit/inspection
• Ensure all auditee attendees are aware of responsibilities and expectations and are familiar with the audit/inspection process
• Ensure all records and information provided to client auditor/inspectors is documented and tracked
• Manage and co-ordinate sponsor audit/regulatory inspection responses and review responses to ensure they address the finding and for appropriateness and completeness.
• Schedule, prepare, conduct and report assigned internal audits of projects and operational processes in accordance with approved procedures, schedules and formats
• Write and issue audit reports in accordance with standard format and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
• Act as mentor and oversee training compliance of QA direct reports as necessary.
• Contributes to the review and development of Biorasi Controlled Documents (CDs) e.g. Standard Operating Procedures, Work Instructions, Forms & Templates
• Assists with continuous improvement efforts related to Quality Management
• Act as Business Partnering to assigned Operational Department
• Contribute as QA Subject Matter Expert (SME) for assigned business function(s)
• Perform ad hoc activities as required
• Assist the head of Quality Assurance to ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.

Requirements

• 10 years of experience as Manager Quality Assurance for clinical trials, as well as CRO experience
• Strong planning, leadership, negotiation and presentation skills.
• Experienced with auditing clinical vendors and investigator sites.
• Practical knowledge of regulations and ICH guidelines with a focus on clinical and quality and compliance
• Excellent verbal, written English communication and presentation skills.

About our company

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, 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.