Job Title: Site Quality Manager
Requisition ID: 50781BR
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals
Experienced Site Quality Leader needed to drive the Manufacturing facility at Pleasanton, California.
- Manage a mix of RUO (ISO 13485 & ISO 9001) and cGMP Quality operations which includes Quality Assurance, Quality Management System, and Quality Control - monitoring and acceptance of incoming raw materials through final production release. Assure compliance to corporate standards and industry standards.
- Manage the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, and manufacturing area support.
- Accountable for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulations (QSR, Part 820)
- Ensure effective transfers of new products into production that meet all the Quality requirements for the classification.
- Coordinate the development of action plans when corrective steps (CAPA) are required and implements these through the site steering team. Responsible for routinely managing, tracking and reporting Critical Success Factor metrics to support plant Quality initiatives.
- Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
- Assist in overall GMP strategy for the site, understanding best practices, and guidance from other GMP sites across the globe and supporting the implementation
- Lead and inspire the Quality team
- Build and maintain effective working relationships across all functions
- Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering).
- A minimum of 5-10 years of management experience in Quality, prefer experience in a GMP or similarly regulated facility.
- Requires thorough knowledge of cGMPs for medical devices or pharmaceuticals.
- FDA audit experience with successful outcomes
- Effective communication skills are required, both written and verbal.
- Problem solving skills are required in situations that are not procedurally managed.
- Knowledge of the pharmaceutical GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems.
- Analytical ability is required to make competent decisions based on a review of analytical data
This position does not have relocation allowance
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