Supplier Quality Engineer
2 months ago
Pay: $49.08/HR to $80.08/HR
Starting contract length: 1 year
Hiring manager is open to hybrid candidates however they expect the majority of their time being in the office in South San Francisco (3 days in a 5-day work week)
Job Description:
- Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements
- Manage designated suppliers and participate as part of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.
Technical Job Responsibilities:
- Support External Quality GxP Supplier Quality Managers in the following activities associated with their role:
- Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions
- Develop, negotiate, and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements
- Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate
- As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs
- As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness
- As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements. This includes support for implementation of or changes to enterprise-wide systems, such as SAP, Veeva and MDMS/GLAS.
Qualifications:
- B.A. or B.S. degree in life sciences or equivalent.
- Previous experience in the pharmaceutical or related industry.
- Ability to interpret quality standards as they relate to GxP suppliers.
- CMO/Supplier/Vendor Oversite.
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