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QA Compliance Lead

QA Compliance Lead

ConfidentialMumbai, Pune
9 days ago
Job description
  • 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 (RCQA) 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

    • Skills Required

    Pharmacy, Chemistry, Biology, Interpersonal

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    Qa Lead • Mumbai, Pune