Director, Clinical Quality Assurance

10+ years

Not Disclosed

Mumbai

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Director of Clinical Quality Assurance (CQA)
Company: Biorasi

About Biorasi
Biorasi is an award-winning, full-service clinical research organization passionate about advancing clinical trials. We are committed to fostering an innovative, collaborative, and dynamic work environment where employees thrive. Join a global team driving new therapies to patients in a fast-paced and growing industry.

Your Role
As the Director of Clinical Quality Assurance, you will oversee Biorasi’s compliance with applicable GCP regulations and standards. You will lead the Clinical Quality Assurance (CQA) function, develop strategic policies, and provide consultation to internal and external stakeholders. Key responsibilities include:

Leading and managing Biorasi’s CQA function, ensuring compliance with national and international GCP regulations.
Developing strategies, policies, procedures, and tools for CQA processes and staff management.
Acting as a key member of the extended Senior Leadership Team, contributing to strategic and tactical decisions.
Serving as a Subject Matter Expert (SME) during regulatory inspections and hosting third-party audits.
Establishing and executing internal QA audit plans, CAPAs, and quality risk management initiatives.
Staying abreast of industry developments and providing guidance on regulations and best practices.
Collaborating with Human Resources and Quality Management to develop and deliver training programs.
Overseeing resource allocation, planning, and budgeting for CQA-related projects.
Championing quality improvement initiatives across people, processes, and technology.
Representing Biorasi at industry events, sponsor meetings, and within the broader business community.

Your Profile

Bachelor’s degree in science, related discipline, or business; Master’s degree preferred.
Fluent in English (oral and written).
Minimum 10 years of experience in drug development or clinical research within the pharmaceutical industry, with at least 3 years in quality assurance or quality management.
Proven ability to manage and develop teams.
Strong organizational skills and ability to multitask in a fast-paced environment.
Deep understanding of ICH GCP and global regulatory requirements.
Excellent communication, presentation, and leadership skills.
Proficiency in computer systems and applications.
Ability to travel up to 25%.

Why Join Biorasi?
We prioritize the well-being of our employees and offer thoughtfully designed benefits, including:

Half-day Fridays.
Paid time off and holidays.
Comprehensive country-specific benefits.
Employee bonus programs.
Career growth opportunities, training, and development.

Apply Now
If you meet the qualifications and want to join a creative, energetic, and collaborative team, visit our Careers Page or email us at careers@biorasi.com.

At Biorasi, we embrace diversity and are committed to creating an inclusive environment. We are proud to be an equal opportunity employer and comply with all fair employment practices. Join us and contribute to advancing clinical research while building your career in a supportive and innovative organization.

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Director, Clinical Quality Assurance

Job Description

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