Sr. Manager, Quality Vendor Management

GENERAL POSITION SUMMARY:

The Sr. Manager, Quality Vendor Management supports the oversight of R&D vendor quality, from selection of external partners through discontinuation. The role is responsible for supporting vendor management, driving quality-quality partnerships with key vendors, facilitating the execution of quality agreements, and identifying and supporting the mitigation of R&D Vendor risks, among other activities. The role will ensure that vendor management activities assurance compliance, excellence and readiness for future needs.

KEY RESPONSIBILITIES:

• Participates in engagement with quality partners at vendors to drive improvement where required develops/maintains quality-quality partnership.
• Identifies, triages, escalates, reports and investigates events and potential risks/gaps
• 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.
• 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.
• Serves as R&D Quality representative in vendor management committees (e.g. JOCs), as requested. Ensures coordination and alignment with functional partners on key messages to vendor on quality of delivery.
• Facilitate holistic vendor management by partnering with QA and stakeholders to conduct end to end vendor management for R&D vendors.
• In collaboration with functional partners negotiates and implements quality agreements or equivalent for vendors performing R&D services using a risk-based approach.
• Provides input in development of audit scope/focus for vendor audits.
• Assist in the development of a service hub to provide Vendor Quality Management expertise regarding mergers and acquisitions.
• Contributes to periodic reporting on R&D vendor risk at appropriate governance forums (e.g. QLT)
• Collaborates within R&D Quality to share information and outcomes of vendor governance meetings.
• Serves as QA Lead for cross-development program and/or cross-functional, significant quality issues related to R&D vendors, ensuring an aligned quality point-of-view is represented, as requested.
• Contributes to proactive inspection readiness activities related to vendors and their oversight.
• 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
• 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.

MINIMUM QUALIFICATIONS:

• 6 or more years of relevant experience in pharmaceutical, medical device or biologics company.
• A Bachelor’s degree in a scientific or allied health field (or equivalent degree).

KNOWLEDGE AND SKILLS:

• Vendor Management or vendor QA experience in a regulated environment
• In depth knowledge of ICH E6, 21 CFR Part 312 and/or 21 CFR Part 58
• Use of electronic Quality Management Systems (e.g. Veeva)
• Quality metrics, dashboards, analysis and improvement programs
• Basic knowledge of 21 CFR Parts 56 and 314 preferred, but not required