QA Governance Specialist

7 days ago

Mumbai Pune, India beBeeRegulatory Full time US$ 90,000 - US$ 1,20,000
Job Description

As a Quality Assurance Compliance Lead, you will play a critical role in shaping the organization's QA policies and procedures. Your expertise in regulatory requirements and ability to influence internal practices will ensure compliance with evolving regulations.

You will provide guidance to internal teams, clients, and regulatory authorities on niche regulatory topics. Additionally, you will host and lead external audits, including regulatory inspections, strategic client audits, and country-specific inspections.

Your responsibilities will also include overseeing the reporting of quality metrics, coordinating the implementation of corrective actions, and leading initiatives aimed at improving compliance and efficiency through process improvements.

Furthermore, you will manage and participate in global Quality initiatives designed to enhance QA practices and improve organizational efficiency.

As a backup for the QA Manager, you will ensure all QA responsibilities are met and provide monthly activity reports as needed.

Finally, you will ensure all Regulatory Compliance and Quality Assurance (RCQA) responsibilities are followed in accordance with controlled documents and industry standards.

Key Responsibilities:

  • Lead Global QA Policies: Take the lead in generating global Quality Assurance policies, offering guidance on regulatory interpretation and application.
  • Subject Matter Expertise: Provide in-depth expertise on niche regulatory topics, offering guidance to internal teams, clients, and regulatory authorities.
  • External Audits/Inspections: Host and lead external audits, including regulatory inspections, strategic client audits, and country-specific inspections.
  • Quality Metrics Continuous Improvement: Oversee the reporting of quality metrics and coordinate the implementation of corrective actions.
  • 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.
  • Compliance Monitoring: Ensure all Regulatory Compliance and Quality Assurance (RCQA) responsibilities are followed in accordance with controlled documents and industry standards.

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