Global Quality Lead
Responsible for quality of assigned product to ensure business objectives are met.
- 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