Sr. Manager, Vendor Quality Management

Sr. Manager, Vendor Quality Management

Position Description

Title/Role: Sr. Manager (Vendor Quality Management)

Area: Small Molecule CMC Compliance

General position summary:

The Sr. Manager, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GMP/GDP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in vendor quality processes and governance to assure remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues.

This position reports to: Associate Director, Small Molecule CMC Compliance - Vendor Quality Management

Key Knowledge/Skills and Competencies:

• Demonstrated working knowledge and experience applying US and international/global regulatory requirements, associated guidance and standards applicable to drug, biologic, combination product, and/or device research, development, manufacturing, and distribution
• Knowledge of regulatory requirements specific to vendor selection and oversight in one or more GxP areas
• Strong working knowledge of risk management and issue management, with a demonstrated ability to apply to third party suppliers carrying out GMP and GDP governed activities
• Strong oral and written communication and interpersonal skills to communicate difficult concepts and persuade others
• Strategic "big picture" thinking while maintaining ability to collaborate effectively and execute efficiently at a tactical level
• Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making
• Skilled in influencing and escalating within a matrixed organization to drive decisions
• Experience advising, coaching, or mentoring junior staff

Key Responsibilities:

• Responsible for Vendor Management of early phase development to commercial Quality function to ensure appropriate and timely vendor qualification and maintenance
• Maintains and manages risk-based model for management and quality oversight of GMP and GDP vendors
• Manage improvements and contribute to the advancement of the GMP and GDP Vendor Management program by identifying opportunities and implementing risk-appropriate enhancements to the Vendor Oversight infrastructure
• Serve as Process Owner for GMP/GDP Quality Agreements, while driving the following responsibilities:
  • Liaise with Sourcing/Contract Management to understand and provide visibility to stakeholders regarding existing, developing, and current agreements with external vendors (e.g., Master Service/Supply Agreement, Quality Agreements, etc.)
  • Support stakeholders in ensuring adequacy of and compliance to Quality Agreements
  • Enable continuous improvement of the GMP/GDP Quality Agreement process
  • Maintain Quality Agreement Performance Dashboard and support development of performance metrics to be presented at Quality Leadership Team and Operational Review forums
• Oversee quality and compliance monitoring across GMP/GDP vendors using vendor oversight strategies, that include but are not limited to:
  • Serve as GMP/GDP interface to vendor QA partners in support of quality management, inspection readiness and continuous improvement
  • Partner with business stakeholders for ensuring adequate governance and quality oversight across vendors
  • Develop/mature Vendor Performance Dashboards /Quality Scorecard and monitor metrics and dashboards for emerging trends across vendors
  • Guide QA teams and stakeholders to assess risk management strategies, vendor selection /remediation, and quality metrics monitoring
• Serve as SME and participate in inspection preparation and management activities for selected vendors as appropriate.
• Support Functional Area QA and QA Audit Team to resolve observations and quality issues arising across vendors, including but not limited to:
  • Risk/impact assessment, specifically with respect to impact across vendors
  • CAPA development, execution, effectiveness assessment
• Maintain and evolve models and mechanisms for ensuring awareness and application of QMS requirements (e.g., qualification, quality agreements, vendor change notification process) across GMP/GDP vendors
• Partner with QA Audit and Inspection Management team and provide input to audits of GMP/GDP vendors
• Provides Quality consultation/direction to internal Technical Operations, Supply Chain, Process Development, and Analytical Development regarding vendor management inquiries
• Lead and/or participate in process improvement projects to evolve quality systems/processes

Preferred Qualifications

• S. (or equivalent degree) and 0-3 years of relevant work experience, or B.S. in a scientific or allied health field and 8+ years of relevant work experience, or relevant comparable background
• Supplier relationship building and supplier expectations management
• Experience with Vendor/Audit management in the GxP space
• Experience participating on cross-functional teams
• Experience using computerized systems including Electronic Document Management (eDMS), Electronic Quality Management System (eQMS) and Electronic Learning Management (eLMS)
• Proficiency in using MS Office applications required (including MS Word, MS Excel, PowerPoint)

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