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    Qa Compliance Lead Auditor (Pv Quality Compliance)

    Fortrea
    2+ years
    Not Disclosed
    Mumbai Pune
    10 Nov. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Global Quality Assurance Expert
    Company: Fortrea

    About Fortrea:
    Fortrea is a global leader in contract research, leveraging decades of clinical development expertise to provide cutting-edge solutions for pharmaceutical, biotechnology, and medical device companies. With operations in over 90 countries, Fortrea transforms drug and device development across more than 20 therapeutic areas, enabling faster and more efficient access to life-changing therapies for patients worldwide.

    Essential Job Duties:

    As a Global Quality Assurance Expert, you will be responsible for ensuring regulatory compliance and driving improvements in quality assurance processes. This role involves leadership, strategic communication, and subject matter expertise to ensure that Fortrea’s global QA practices remain aligned with industry standards and regulatory requirements.

    • Lead Global QA Policies: Take the lead in generating global Quality Assurance policies, offering guidance on regulatory interpretation and application. Influence internal practices and ensure policies align with evolving regulations.
    • Subject Matter Expertise: Provide in-depth expertise on niche regulatory topics, offering guidance to internal teams, clients, and regulatory authorities. Serve as the point of contact for regulatory audits and inspections.
    • External Audits/Inspections: Host and lead external audits, including regulatory inspections, strategic client audits, and country-specific inspections. Ensure timely and comprehensive responses to audit findings.
    • Quality Metrics & Continuous Improvement: Oversee the reporting of quality metrics and coordinate the implementation of corrective actions. Lead initiatives aimed at improving compliance and efficiency through process improvements.
    • Quality Initiatives: Manage and participate in global Quality initiatives designed to enhance QA practices and improve organizational efficiency.
    • Support QA Manager: Act as a backup for the QA Manager, ensuring all QA responsibilities are met. Provide monthly activity reports and support other QA activities as needed.
    • Compliance Monitoring: Ensure all Regulatory Compliance and Quality Assurance (RC&QA) responsibilities are followed in accordance with controlled documents and industry standards.
    • Additional Duties: Perform other QA-related duties as assigned by management, contributing to the success of the broader organization.

    Experience:

    • Minimum of 8 years of experience in the regulatory environment, particularly in GXP roles (Good Clinical, Good Manufacturing, Good Laboratory Practices).
    • Expertise in regulatory requirements, with detailed knowledge of specific regulations (or multiple regulations) and their application to clinical research.
    • Experienced Lead Auditor, capable of managing external audits and inspections, and ensuring compliance with regulatory standards.
    • Proven track record of strategic communication with clients and regulatory authorities.
    • Strong background in leading process improvement initiatives and driving continuous quality enhancements within organizations.

    Qualifications:

    • Minimum Required:
      • A Bachelor’s Degree in Pharmacy, Chemistry, Biology, or a related field.
      • Postgraduate degree (MSC or equivalent) in a science or management-related discipline is preferable but not required.
      • Equivalent professional experience may substitute educational requirements.
    • Desirable Skills:
      • Strong leadership abilities, particularly in managing cross-functional teams.
      • Excellent communication and interpersonal skills to effectively engage with clients and regulatory bodies.

    Why Join Fortrea?

    At Fortrea, we’re looking for motivated problem-solvers who are passionate about overcoming the barriers in clinical trials. We offer an exciting opportunity to make a meaningful impact on global healthcare by leading transformative initiatives. As part of our team, you'll embrace a collaborative workspace where personal and professional growth are equally prioritized, enabling you to drive innovation and success within the clinical research sector.

    Fortrea is an Equal Opportunity Employer:
    Fortrea is committed to fostering a diverse and inclusive workplace. We do not tolerate harassment or discrimination of any kind and make employment decisions based on qualifications and business needs. We encourage all individuals, regardless of race, religion, gender, sexual orientation, disability, or any other protected characteristic, to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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