Senior Manager Quality Assurance Operations Lead

1 month ago


GondrecourtleChâteau, Grand Est, United States Bridgeway Partners Full time
Senior Manager Quality Assurance Operations Lead

Bridgeway Partners is seeking a seasoned Senior Manager Quality Assurance Operations Lead to spearhead our quality assurance efforts in drug product manufacturing, packaging, and labeling. This is a fantastic opportunity to join a dynamic team driving innovation and quality in the life sciences industry.

Key Responsibilities:
  • Develop and implement comprehensive quality assurance strategies to ensure compliance with regulatory requirements (FDA, EMA) and industry best practices.
  • Provide leadership and support to Quality Assurance teams, ensuring adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Oversee incoming material inspection, in-process quality assurance, and final product release.
  • Manage and monitor key performance indicators (KPIs) related to quality metrics, providing regular updates to senior management.
  • Collaborate with cross-functional teams, including Manufacturing, Supply Chain, Regulatory Affairs, and Quality Control, to resolve quality issues and enhance product lifecycle processes.
  • Lead training programs to foster a culture of quality and regulatory compliance within the organization.
Qualifications:
  • 6 years of relevant quality assurance experience in drug product manufacturing, with at least 2 years in a leadership role.
  • Strong expertise in FDA and EU regulations related to biologics manufacturing (21 CFR Part 210, 211, 610).
  • Bachelor's degree in a life science discipline preferred.
  • Experience with labeling in a regulated environment is an asset.


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