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Global Quality Assurance Manager

2 months ago

King of Prussia, Pennsylvania, United States CSL Behring Full time
About the Role

CSL Behring is seeking a highly skilled Global Quality Assurance Manager to join our team. As a key member of our Global Quality Assurance team, you will be responsible for managing global quality assurance activities in various regions and globally.

Key Responsibilities:

  • Develop and implement global quality audit programs for assigned projects and compliance areas.
  • Perform risk assessments, track progress, and coordinate with clinical development and operational responsibilities to provide a current quality risk-based audit program.
  • Implement audit programs through self-inspections/audits of internal processes, clinical investigator sites, clinical databases, study reports, contract CROs/vendors, and/or Independent Ethics Committees/Institutional Review Boards.
  • Develop, review, and issue audit reports outlining findings and CAPA recommendations.
  • Approve CAPA plans resulting from audits and inspections.
  • Manage individual CAPAs to ensure issues are thoroughly evaluated and addressed.
  • Directly follow-up on observations resulting from audits of 3rd party vendors and oversee timely CAPA resolution.
  • Identify non-compliance trends and systematic risks for assigned areas of responsibilities.
  • Escalate non-compliances/trends to Line manager/Head, Global Quality Assurance.

Requirements:

  • University degree in a scientific discipline or related field.
  • Minimum of 5 years of professional work experience in clinical research in the pharmaceutical industry, with a minimum of 4 years' experience in a Quality Assurance or Compliance function globally operating.
  • Strong knowledge of industry regulations and clinical development processes, with emphasis on local and international standards and regulations and associated GxP guidelines.
  • Experience in a management role is desirable.
  • Experience working in a Quality-related and/or Process Management-related environment/role.
  • Strategic development and analytical skills.
  • Experience managing processes with a continuous improvement approach.
  • Analyze complex circumstances and problems, and guide appropriate actions.
  • Experience in resource and budget management.
  • Ability to work and collaborate at all levels within an organization.
  • Domestic and international travel may be required.

About CSL Behring:

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We want CSL to reflect the world around us:

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.