Global Quality Assurance Lead

Job description

Global Quality Lead

Responsible for quality of assigned product to ensure business objectives are met.

Key Responsibilities:

  • Maintains the primary product quality lead with oversight for project activities and the team members to achieve on-time quality deliverables, high customer value, and profitable results.
  • Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products
  • Makes recommendations with oversight for key decisions on product quality and compliance and regulatory conformance issues
  • Maintains relationships and open communication with Third Party Manufacturers (TPMs)
  • Liaises with external companies’ quality organization to maintain a consistent level of quality
  • Contributes to Quality Assurance elements needed to facilitate new product launches including TPMs and on site manufacturing
  • Supports the management of exception documents and Corrective and Preventive Actions.  Initiates Change Plans, performs follow-up, and timely closure of the change plans.
  • Collects product quality transfer process monitoring metrics.
  • Obtains and reviews summaries of the Annual Product Reviews from the TPMs to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
  • Responsible for material specification documents that need to be established on site. 

Education & Experience:


  • Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.

  • 7+ years of total combined experience. At least 3 years in Quality Assurance Operations; 3 years in Operations, Research and Development or Consulting.  Direct Plant experience in a Pharmaceutical setting is distinct advantage

  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, devices, tablets, granulations and/or active pharmaceutical ingredients

  • Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, problem solving skills and capable of performing as leaders

If you want to propel your QA career into a more global based role and work for one the