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Job Description

GENERAL POSITION SUMMARY:

The Director Vendor Quality Management (VM) position provides strategic leadership and quality oversight across small molecule GMP/GDP vendor management activities. This individual is responsible for maturing the existing vendor management processes, including advancement of vendor performance scorecards, providing strategic direction related to the processes and mechanisms for vendor risk assessments and mitigation plans as well as ensuring adequate and sustained vendor governance. This position within the Small Molecule CMC Compliance function is vital to the advancement of excellence in the vendor management space and is responsible for developing innovative approaches to ensure continuous quality improvement. This role requires strong leadership skills, extensive people management experience and the ability to be independent and autonomous and lead effective teams.

KEY RESPONSIBILITIES:

• Lead small molecule GMP/GDP Vendor Management (VM) function with responsibility for the overall performance and effectiveness of the VM program
• Ownership of Quality Agreement standards, templates and maintaining currency with Vertex QMS standards, new regulatory requirements and evolving best practices/standards
• Accountable for advancing QA vendor quality risk and governance including providing oversight /guidance on remediation activities
• Accountable for maintaining the integrated GMP/GDP Approved Vendor list and ensuring transparency to QA and business for use in operations and management
• Collaborates for alignment with QA (e.g. Functional Area QA, Audit, Computer Systems QA) and business area stakeholders in risk identification and assessment
• Partners with Strategic Sourcing, Global Vendor Management, Audit/Inspection Management, Quality Operations and other cross-functional teams for alignment and collaboration in integrating quality performance/monitoring with corporate vendor management models and practices
• Ensures risks and key quality issues identified through vendor management oversight are escalated, and robust mitigation plans are implemented
• Continually evaluates opportunities to modify the VM team's approach, resource deployment and areas of focus to align with top risk reduction priorities across CMC areas, including third parties/vendors
• Actively champions, models and drives for continual improvement and excellence in execution, to bring insights and leading practices for enabling commercial success and pipeline advancement through proactive and effective quality management.
• Champions a culture of continuous learning across the team with regard to CMC operational areas and technology platforms as well as the industry standards for vendor oversight and risk management
• Leads and engages VM function (4-8 colleagues) within Quality Assurance for excellence in delivery of organizational and operational strategies and goals
• Provides strategic direction and management of vendor management quality governance and partners with QA and business leaders and stakeholders in the deployment and execution of quality governance in accordance with business models, contractual agreements and the overall QMS
• Interacts with global regulatory agency representatives with technical, professional competence, achieving positive outcomes necessary for the success of the business
• Maintains a vibrant professional network, staying current on leading edge regulatory agency and industry thinking, and integrating that into the Vertex Quality strategy and QMS
• Develops productive partnerships with senior management across CMC areas and models collaboration and partnership with QA leaders and teams for excellence in vendor quality oversight management and in support of proactive quality risk management across the QA organization

• Partners effectively with SM CMC Leadership to ensure a collaborative, progressive and productive culture across quality that engages, develops, retains, and advances staff, and delivers excellence in talent management and succession readiness for organizational effectiveness and sustainability

Key Technical Knowledge, Skills and Competencies:

• Demonstrated depth and breadth of global health regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for quality, efficiency, compliance and effectiveness
• Broad and deep quality management, vendor management, process management, project management and continuous improvement knowledge and experience
• Demonstrated strategic planning and execution skills required
• Proven ability to design/evolve and /or implement Quality Management Systems (e.g. Quality Standards, Quality Agreements, Risk Assessments, Metrics/Dashboards, Quality Governance) in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model
• Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
• Proven leadership capabilities within a multi-level organization to support development of individuals and teams;
• Creative, innovative leadership experience with strong change management experience, adaptability and resourcefulness
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
• Strong problem solving and critical thinking skills, accompanied by analytical thinking/data analysis skills required to make sound decisions

MINIMUM QUALIFICATIONS

• Master’s degree and 8+ years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 12 + years of relevant work experience, or relevant comparable background.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

1. On-Site and work 5 days per week with ad hoc flexibility;

2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select

#LI-AR1 #LI-Hybrid

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