R&D Vendor Quality Management Senior Manager (Remote Eligible)

Job Description

General Summary:

The Vendor Quality Management Senior Manager proactively assesses R&D laboratory vendor risk and translates this assessment into insights, recommendations, and actions that allow Vertex to demonstrate appropriate and tailored oversight of our third parties. The role contributes to advancement of processes, tools, and systems that are fit-for-purpose across R&D GxP laboratory vendors.

Key Responsibilities:

 The responsibilities of this position may include, but are not limited to, the following:

·        Facilitate holistic vendor management by partnering with Quality and functional stakeholders to conduct end to end vendor management for R&D laboratory vendors.

·        In collaboration with functional and quality partners, assures and implements the appropriate level of quality oversight for R&D vendors and vendor engagements based on risk.

·        In collaboration with functional partners negotiates and implements quality agreements or equivalent for vendors performing R&D services using a risk-based approach.  

·        Partners with functional and quality teams to implement strategies for vendor oversight approaches for vendors based on risk and develops and reviews R&D-specific vendor quality performance metrics (e.g. KQIs) across contracted R&D activities

·        Participates in engagement with quality partners at vendors to drive improvement where required develops/maintains quality-quality partnership.

·        Serves as R&D Quality representative in vendor management committees (e.g. Joint Operating Committees (JOC)), as requested. Ensures coordination and alignment with Vertex functional partners on key messages to vendor on quality of delivery.

·        Seeks out, integrates, and translates data and insights across programs and activities supported by a vendor.  Develops a coherent profile of vendor quality performance and compliance.

·        Contributes to the timely and effective communication of vendor risk, including both global and R&D-specific components, as well as other summary data on vendor performance to relevant partners.

·        Identifies, triages, escalates, reports and investigates quality events and potential risks/gaps

·        Contributes to proactive inspection readiness activities related to vendors and their oversight.

·        Contributes to periodic reporting on R&D vendor risk at appropriate governance forums (e.g. Quality Leadership Teams (QLT))

·        Serves as QA Lead for cross-development program and/or cross-functional, significant quality issues related to Vertex R&D vendors, ensuring an aligned quality point-of-view is represented, as requested.

·        Collaborates within R&D Quality to share information and outcomes of vendor governance meetings.

·        Partners with internal stakeholders to optimize processes, ensuring comprehensive operational and quality vendor oversight.

·        Provides input in development of audit scope/focus for vendor and internal audits.

Knowledge and Skills:

• Vendor Management or vendor QA experience in a regulated environment

• Use of electronic Quality Management Systems (e.g. Veeva)

• Quality metrics, dashboards, analysis and improvement programs

• In depth knowledge of ICH E6 (as it applies to the laboratory setting), 21 CFR Part 312 and/or 21 CFR Part 58

• Basic knowledge of 21 CFR Parts 56 and 314 preferred, but not required

JOB COMPETENCIES:

• Lead by Example
• Learn, Teach and Develop.
• Foster Exceptional Collaboration
• Drive Break Through Results
• Promote Enterprise Thinking

Minimum qualifications:

• A Bachelor’s degree in a scientific or allied health field (or equivalent degree).
• 6 or more years of relevant experience in pharmaceut