Director of Manufacturing Quality Assurance

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz R&D Partners Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

Passionate about science and innovation? Your dream Quality Assurance position awaits in the biologics industry

R&D Partners is seeking a Manufacturing Quality Assurance Group Lead (Director level) to oversee and manage quality assurance operations for biologics manufacturing. This South Korea-based role offers a comprehensive relocation package and is ideal for experienced QA leaders ready for an international opportunity. You will ensure compliance with global quality standards, support manufacturing processes, and lead quality-related decision-making. This position requires strong leadership skills, expertise in biologics manufacturing, and the ability to collaborate effectively with internal teams and external stakeholders.

Please note this role is based in South Korea and relocation will be necessary.

Responsibilities:

  • Oversee and manage quality assurance tasks for biologics manufacturing operations.
  • Ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
  • Conduct reviews and approvals of quality records, including line clearances, process oversight, and campaign readiness.
  • Analyse quality data to identify trends, risks, and areas for improvement.
  • Lead internal audits and inspections, particularly for cleanroom and manufacturing operations.
  • Collaborate with manufacturing teams to address quality issues and implement process improvements.
  • Communicate effectively with clients and stakeholders to ensure alignment with global standards and maintain strong relationships.

Key Skills and Requirements:

  • Previous working experience in biologics manufacturing and quality assurance.
  • Proven line management experience of 30+ FTEs.
  • Background in biologics manufacturing, including drug substance (DS) and drug product (DP) processes.
  • Hands-on experience in quality assurance at the operational level, such as walkthroughs, line clearances, and campaign readiness.
  • Expertise in leading audits and inspections, with a focus on cleanroom and manufacturing operations.
  • Knowledge of cell culture processes or verification.
  • Experience in internal audits and working within a Contract Development and Manufacturing Organization (CDMO) environment is highly valued.
  • Strong understanding of global regulatory guidelines (e.g., FDA, EMA, ICH).
  • Ability to manage and lead a team effectively.
  • Proficiency in analyzing quality metrics and writing technical documents.
  • Bachelor's degree in bioscience, bioengineering, biochemistry, molecular biology, or a related field.

Relocation & Benefits:

  • Fully paid rental housing (employee covers utilities only).
  • Round-trip flights and door-to-door international relocation support.
  • Child education assistance.
  • Free meals provided daily.
  • Korean language education support.
  • National pension, health insurance, and retirement allowance.
  • 15 days of annual leave and annual health exams.
  • Bonus scheme.

For more information, please contact
Billy O'Brien.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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