Strategic Quality Assurance Leader

1 day ago

Ahmedabad, Gujarat, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,00,00,000
Job Title

Job Overview:

This is a senior leadership role responsible for the strategic direction, oversight, and execution of all Quality Assurance (QA) and Regulatory Affairs (RA) functions.

Key Responsibilities:

  • Develop and implement QA and RA strategies aligned with business goals
  • Lead cross-functional teams to ensure quality and regulatory compliance throughout the product lifecycle
  • Represent the company in regulatory and quality discussions with external stakeholders
  • Provide regular updates and reports to the Leadership and Board on compliance status, risks, and strategic initiatives
  • Oversee the Quality Management System (QMS) ensuring compliance with ISO 13485, GMP, GDP, GVP, and MDD/MDR standards
  • Lead internal and external audits, inspections, and quality improvement initiatives
  • Manage CAPA, non-conformance, and complaint handling processes
  • Ensure validation of equipment, processes, and software used in manufacturing and testing
  • Supervise final batch release, documentation control, and production line clearance
  • Champion continuous improvement initiatives and foster a culture of quality across the organization
  • Develop and execute regulatory strategies for India and international markets
  • Maintain compliance with MAH requirements and marketing practices
  • Lead regulatory due diligence for licensing, acquisitions, and partnerships
  • Monitor and communicate changes in regulatory requirements to senior management
  • Coordinate Medical Device Reporting, product recalls, and safety notifications

Required Skills and Qualifications:

  • Master's degree in Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, or related field
  • Minimum 15 years of experience in QA and RA, with at least 5 years in a leadership role in the medical device or pharmaceutical industry
  • Proven expertise in ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, GDP, and GVP
  • Experience in hosting and leading audits by regulatory authorities
  • Strong project management, analytical, and problem-solving skills
  • Excellent communication, interpersonal, and leadership abilities
  • Proficiency in Microsoft Office and QMS software tools
  • Regulatory Affairs Certification (RAC) or equivalent preferred

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