Associate Director, Specialty Laboratory Vendor Quality

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Position Summary

The Associate Director of Specialty Laboratory Vendor Quality will be mainly responsible for implementing the strategy for GCP/GCLP/GLP specialty laboratory (i.e., biomarker) vendors from a quality perspective and delivering the full range of quality. This role reports directly to the Director, Specialty Laboratory Quality.

Key Responsibilities:

• Support independent quality vendor oversight through audits and inspections

• Implement the quality strategy for Specialty Laboratory Vendors:

• Assess and manage specific risk areas associated with clinical vendors

• Partner with the business/cross functional teams to establish and monitor quality KPIs, addressing issues proactively

• Drive continuous quality process improvements/oversight initiatives to enhance quality efficiency and compliance

• Create a quality narrative summarizing the result of evidence of quality activities related to vendor oversight and data integrity

• Support independent vendor quality oversight:

• Provide direction and oversight to the vendor qualification and audit program to ensure regulatory compliance

• Develop the audit strategy for clinical laboratory vendor audits, including audit scope to assess the vendors risk, quality systems, capabilities and performance

• Supports the development of clinical laboratory Quality Agreements and the set-up of the respective quality governance

• Co-Manages QA-to-QA relationship with preferred/critical CROs and vendors

• Audits and Inspections:

• May conduct GCP/GCLP/GLP audits and inspections at various BMS sites and/or functional areas, and contract research organizations, depending on departmental resource needs

• Engage in activities to support product submission, registrational filings and inspections

Qualifications & Experience:

• B.S. and/or M.S. in Chemistry, Biology, IT or Health related

• Minimum 5 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

• Specific Knowledge:

• Demonstrated strong knowledge of GCP/GCLP/GLP regulatory requirements and guidelines as they related to the analysis of clinical trial biospecimens.

• Clinical research processes and principles of Quality Assurance

• Demonstrated ability to work in an international environment leading global quality functions.

• Knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.

• Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external stakeholders.

• Excellent presentation skills for compelling peer and Senior Management communication.

• Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

Approximately 20% travel may be required in this position.

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