Schedule note: The hiring manager is open to hybrid candidates however they expect most of their time to be in the office in South San Francisco ( 3 days in a 5-day work week).
Job Description:
This position is more of a Quality Oversight of CMOs.
Qualifications and Skills
B.A. or B.S. degree in life sciences or equivalent
3+ Years of experience
Hands-on laboratory experience
Familiarity with root cause analysis tools
Passion to learn
Previous 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.
Ability to communicate clearly and professionally both in writing and verbally
Main Purpose of the Position
Support External Quality GxP Supplier Quality Managers in the following key aspects of their role:
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 decommission.
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, 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 in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation concerning 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 the 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 the client's 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 the client policies, procedures and job descriptions.
Be accountable for behaviors described in the 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.