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    Director, Clinical Quality Assurance

    Biorasi
    10+ years
    Not Disclosed
    Mumbai
    10 Nov. 26, 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

    Join Biorasi: Lead the Future of Clinical Research Quality

    At Biorasi, we are dedicated to transforming clinical research and bringing new therapies to patients worldwide. As an award-winning, full-service clinical research organization, we emphasize innovation, collaboration, and a dynamic work environment. We are growing rapidly and seeking professionals passionate about clinical research and quality assurance to join our energetic, forward-thinking team.

    Your Opportunity:

    We are seeking a Clinical Quality Assurance (CQA) Leader to guide our organization’s compliance and quality assurance efforts. This senior role involves shaping strategy, ensuring adherence to global regulations, and driving a culture of quality and continuous improvement.

    Your Role:

    • Strategic Leadership:

      • Develop CQA strategy, policies, procedures, and tools under the guidance of the SVP of Quality.
      • Serve as a member of the extended Senior Leadership Team, contributing to strategic and operational decisions.

    • Regulatory Expertise:

      • Ensure adherence to global Good Clinical Practice (GCP) standards and regulatory requirements.
      • Serve as a Subject Matter Expert (SME) during regulatory inspections, audits, and sponsor engagements.

    • Operational Excellence:

      • Design and implement QA audit plans, Corrective and Preventive Actions (CAPAs), and risk management processes.
      • Oversee resource allocation, budgets, and timelines for CQA activities across clinical projects.
      • Collaborate with operational teams to detect and mitigate quality risks promptly.

    • Training and Development:

      • Partner with HR and Learning teams to develop and deliver training programs on applicable GCP regulations and quality processes.

    • Process Improvement:

      • Champion strategic initiatives to enhance people, processes, and technology.
      • Collaborate with internal teams on implementing quality management systems and continuous improvement programs.

    • Stakeholder Engagement:

      • Maintain relationships with sponsors and partners, providing guidance on regulatory and quality matters.
      • Represent Biorasi at external events, sponsor meetings, and public forums.

    • Compliance and Communication:

      • Promote a culture of quality, respect, and collaboration within Biorasi.
      • Ensure team alignment with Biorasi policies and regulatory standards.

    Your Profile:

    • Education:

      • Bachelor's degree in science, related scientific discipline, or business (Master's degree preferred).

    • Experience:

      • 10+ years in clinical research or drug development within the pharmaceutical industry, including 3+ years in quality assurance or quality management.
      • Proven experience managing teams and leading quality-focused initiatives.

    • Skills:

      • Strong organizational, multitasking, and prioritization skills.
      • Deep knowledge of ICH GCP and global regulatory standards.
      • Exceptional verbal, written, and presentation communication abilities.
      • Proficiency in using relevant technology and tools.

    • Travel:

      • Ability to travel up to 25% of the time.

    Why Biorasi?

    • Work-Life Balance: Enjoy half-day Fridays, paid time off, and holidays.
    • Comprehensive Benefits: Extensive country-specific benefits, including medical, dental, vision, and life insurance.
    • Professional Growth: Access to training programs, career development opportunities, and tuition reimbursement.
    • Rewards: Participate in employee bonus programs.
    • Culture: Be part of a diverse, inclusive, and collaborative environment committed to quality and innovation.

    If you’re ready to elevate your career in clinical research quality assurance, apply today at biorasi.com or send your resume to careers@biorasi.com.

    Biorasi is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We comply with all fair employment practices regarding citizenship and immigration status.

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