Senior Manager of Quality Assurance at LumaBio Partners in Philadelphia, Pennsylvania

Posted in Other 1 day ago.

Type: full-time





Job Description:

Our client are looking for a Senior Quality Assurance (QA) Manager to oversee and manage the Quality Assurance function within our pharmaceutical manufacturing operations. This role requires a deep understanding of GMP (Good Manufacturing Practices), regulatory compliance, and quality systems to ensure the safety, efficacy, and quality of our pharmaceutical products.

The Senior QA Manager will lead the QA team, collaborate cross-functionally, and ensure that our products meet the highest quality standards, from development through production to delivery.

  • Lead, mentor, and develop the QA team, fostering a culture of continuous improvement and high performance
  • Oversee day-to-day QA operations, ensuring that all activities align with company goals and regulatory requirements.
  • Ensure product quality throughout the manufacturing process, from raw materials to finished goods.
  • Oversee batch record review, CAPA (Corrective and Preventive Action) management, deviation investigations, and risk management processes.
  • Identify opportunities for process improvements within manufacturing operations to ensure quality and efficiency.
  • Support the development and optimization of manufacturing processes through collaboration with operations, R&D, and other departments.
  • Strong knowledge of FDA, EMA, ICH guidelines, and other global regulatory requirements.
  • Proven experience in managing QA teams, ensuring GMP compliance, and overseeing quality systems in a pharmaceutical manufacturing environment.

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