Senior Quality Manager, External Manufacturing

1 month ago

Shanghai, Shanghai, China Organon Full time

Job Summary

We are seeking a Senior Quality Manager to lead our External Manufacturing team in Shanghai, China. The successful candidate will be responsible for ensuring the quality of our products manufactured at external entities, adhering to regulatory requirements and company policies.

About the Role

The Senior Quality Manager will oversee all activities associated with external manufacturing, including quality oversight, audit readiness, and complaint management. This role requires strong leadership skills, with the ability to manage a team of quality assurance professionals and ensure compliance with established policies and procedures.

Key Responsibilities

  • Quality Oversight: Ensure that all activities at external manufacturing sites are performed in accordance with approved processes and methods, and comply with applicable regulatory requirements.
  • Audit Readiness: Maintain permanent audit readiness, ensuring that all necessary documentation and records are up-to-date and compliant.
  • Complaint Management: Investigate and resolve complaints related to external manufacturing, ensuring timely and effective resolution.
  • Team Leadership: Manage a team of quality assurance professionals, providing guidance, coaching, and development opportunities.
  • Communication: Communicate effectively with local health agencies, contract manufacturers, and other stakeholders to ensure smooth operations and compliance.

Requirements

  • Educational Background: Minimum four-year degree in Science, Engineering, or relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering).
  • Experience: At least 5 years working experience in pharmaceutical production and quality management, with at least 3 years in sterile manufacturing and quality management.
  • Skillset: Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

Additional Information

This is an exciting opportunity to join Organon's team as a Senior Quality Manager in Shanghai, China. If you have a passion for quality management and leadership, we encourage you to apply.

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