Quality Assurance Manager

Core Healthcare - Winnipeg, MB (30+ days ago)

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Manage and oversee Quality Operations - Winnipeg site.

  • Manage QA staff and establish and implement effective Corporate Quality compliance guidance and programs to ensure GMP Regulatory requirements are met
  • Drive an effective environment conducive to continuous quality improvement
  • Establish regulatory inspection management strategies and supports sites during inspections
  • Performs QA oversight of supplier audits, qualification and quality agreement and when needed, partner with operations, site Quality and supply chain management in addressing supplier quality issues;
  • Manage Company document system ensuring its maintenance and updating, cooperating with different company functions;
  • Develop and assure monitoring and maintenance of the Quality Metrics and KPIs at the corporate level and ensure that analysis of data coming from site metrics are assessed and communicated at the corporate level;
  • Collaborate with regulatory affairs (RA) to support fillings;
  • Promote a culture of quality and operational excellence;
  • Manage and ensure development of effective staff.

Requirements

  • 10-15 years of experience in a highly GMP regulated, commercial environment pharmaceutical industry
  • Minimum 5 years’ senior quality assurance leadership role
  • Expert understanding of appropriate global drug and GMP regulations requirements and standards
  • Ability to manage multiple projects in a dynamic and fast paced environment
  • Strong manager with track record of recruiting and developing teams and individual talent
  • Self-motivated and ability to manage time working on multiple projects simultaneously

Job Type: Full-time