Regulatory Affairs and Quality Assurance Manager

4 days ago

Quezon City, National Capital Region, Philippines QuickStart Solutions Full time $90,000 - $120,000 per year
Job Responsibilities
  • Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO, FDA, and other applicable standards.
  • Conduct internal and external audits to assess compliance and drive corrective/preventive actions (CAPA).
  • Manage product quality issues, including customer complaints, deviations, and non-conformances.
  • Ensure regulatory compliance across all operational areas, including product registration, labeling, and documentation.
  • Act as the primary contact with regulatory agencies for inspections, audits, and product submissions.
  • Oversee supplier qualification and monitoring to ensure quality of raw materials and services.
  • Provide regulatory and quality guidance to cross-functional teams throughout the product lifecycle.
  • Train and lead QA/RA team members, fostering a strong culture of quality and compliance.
Job Qualifications
  • Bachelor's degree in Pharmacy, Life Sciences, Engineering, or a related field (Master's preferred).
  • 5+ years of experience in Quality Assurance and/or Regulatory Affairs, preferably in a regulated industry (pharma, medical devices, cosmetics, or food).
  • Strong knowledge of regulatory standards such as FDA, EMA, ISO 13485, GMP, and other applicable regulations.
  • Experience managing audits and inspections, including interactions with regulatory authorities.
  • Proficient in quality tools and systems, such as CAPA, risk management, and document control software.
  • Excellent communication skills, both written and verbal, for effective collaboration and regulatory correspondence.
  • Strong leadership and project management skills, with experience in team supervision and cross-functional coordination.
  • Analytical and problem-solving abilities, with a detail-oriented and proactive approach to compliance.

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