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Supplier Quality Specialist

2 months ago

South San Francisco, United States eTeam Full time

Job Title: GxP Supplier Quality Specialist/Contractor

Duration: 12+ months


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, Client 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.



Functional Job Responsibilities:

  • Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Client objectives.
  • Notify relevant GxP Supplier Quality Managers and/or Senior Management of potential quality or regulatory issues impacting product quality or regulatory compliance.
  • Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
  • Sign documents as authorized and described by Client policies, procedures and job descriptions.
  • Be accountable for behaviors described in Client's Code of Conduct.
  • Deliver business outcomes in support of departmental objectives.
  • Maintain and communicate work priorities to meet goals and timelines.
  • Timely complete all job-related training requirements before performing GMP-job functions and strive to continuously improve knowledge and skills in quality, compliance and technology.
  • Perform other quality-related activities and projects to ensure quality, compliance, and continuous improvement.
  • Train other interns as required


Qualifications and Skills:

  • B.A. or B.S. degree in life sciences or equivalent
  • Previous 4-7 years experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus
  • Ability to interpret quality standards as they relate to GxP suppliers
  • Operational Excellence expertise is a plus
  • Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.

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