Shaun Gordon

Dynamic clinical quality leader with extensive experience at Bristol-Myers Squibb, driving Quality by Design principles and ensuring GCP compliance. Proven track record in audit oversight and CAPA management, enhancing operational efficiency and fostering cross-functional collaboration. Adept at navigating complex regulatory landscapes while maintaining strong business relationships.

• 03/01/25, Present, Director Clinical Quality Lead, Kardigan Inc., Princeton, NJ, The Clinical Quality Lead plays a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&D process. This role is responsible for managing GxP Quality Assurance (QA) functions and providing consultation in the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate., Partners with Clinical Development/Operations and actively participate in clinical study teams to ensure GCP compliance. Reviews study-related documents and plans., Support and maintain the internal audit program, audit schedule, and approved vendor list. Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines., Communicates audit results to internal stakeholders and writes audit report., Supports Quality Management System (QMS) including quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling., Monitor, track, and trend GxP non-conformances, deviations, CAPAs., Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections., Responsible for maintaining current regulatory inspection knowledge as it relates to inspections by regulatory agencies worldwide., Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies., Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&D organization (GCP, GVP, GLP)., Support in training initiatives on processes, new regulations and systems to enable quality compliance., Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.
• 11/01/20, 03/01/25, Associate Director, Risk Management Lead, Bristol-Myers Squibb, Lawrenceville, NJ, The role guided and enabled corporate and R&D objectives and supports Quality by Design principles by collaborating to establish, maintain and operationalize a framework for Clinical Risk Management, in partnership with stakeholders across R&D and Global Quality. Responsibilities will include:, Guided corporate and R&D objectives, supporting Quality by Design principles, by executing GCP risk assessments, reducing cycle times., Collaborated with study teams to implement Quality by Design from protocol development to data analysis, improving focused and targeted data integrity., Conducted and Lead inspection readiness training, Community of Practice and associated efforts in supporting audits and inspections in collaboration with Global Quality, reducing audit findings., Acted as CAPA lead, conducting root-cause analyses, and implementing corrective actions., Acted as a SPARK (departmental liaison: 2-year nominated rotation) to the divisional leadership team, contributing to implementation and adoption of enterprise change management strategies.
• 03/01/18, 11/01/20, Planning & Execution Lead, Bristol-Myers Squibb, Lawrenceville, NJ, This position managed the Biometric processes of drug development programs including key aspects such as clinical trials reporting and regulatory filing activities., Managed Biometric processes for drug development, including clinical trial reporting and regulatory filings, ensuring compliance and accuracy., Oversaw strategic planning and execution for Biometrics & Data Sciences deliverables across multiple programs, enhancing efficiency and collaboration., Successfully managed regulatory submissions and approvals in oncology and hematology, contributing to the advancement of critical therapies.
• 07/01/16, 03/01/18, Outsourcing Manager, Bristol-Myers Squibb, Lawrenceville, NJ, Under the remittance of Central Clinical Planning and Solutions, Scientific Vendor & Outsourcing Management; the Outsourcing Manager is focused on executing the business’ sourcing strategy across all phases of R&D development operations focusing on Central Labs, Local Labs, Biomarker Vendors Partners, and Imaging Vendor Partners., Executed sourcing strategies for R&D operations, enhancing vendor relationship management and ensuring compliance with clinical procedures., Acted as point of contact for issue escalation and remediation across clinical trials, improving resolution efficiency., Led continuous improvement initiatives for sample tracking, increasing tracking accuracy across global clinical operations.
• 05/01/14, 07/01/16, Contracts Manager, Integra LifeSciences Corporation, Plainsboro, NJ, As a member of the Law Department: Drafted, negotiated, and executed various complex agreements for the Orthopaedics and Tissue Technologies business unit of Integra LifeSciences Corporation for domestic and international markets., Drafted and negotiated complex agreements for domestic and international markets, contributing to revenue targets., Led contract integration initiatives post-acquisition, enhancing operational efficiency., Provided training on contracting processes, improving team compliance and process adherence.
• 05/01/12, 05/01/14, Sr. Global Agreements Specialist, Merck (RPS), Kenilworth, NJ, Prepared, negotiated and executed domestic and global master agreements, clinical research agreements, amendments, confidentiality agreements, informed consent agreements, facility use agreements, corporate integrity agreements, and other ancillary agreements as needed through all phases of drug development., Managed and negotiated a variety of agreements, ensuring compliance and quality management systems, resulting in successful partnerships and streamlined processes., Led the negotiation and execution of agreements, achieving a 90% success rate in contract finalizations and contributing to efficient drug development operations.
• 10/01/11, 03/01/12, Associate Manager: Global Clinical Contracts, Celgene, Summit, NJ, Responsibilities included the development, amendment, execution and management of domestic and global master agreements, clinical research agreements, confidentiality agreements, informed consent agreements, facility use agreements and corporate integrity agreements with clinical investigators., Led the development and management of clinical and confidentiality agreements with clinical investigators, ensuring compliance and quality management systems., Implemented and executed agreements, contributing to the successful completion of clinical trials and research projects, increasing efficiency.
• 08/01/10, 08/01/11, Senior Consultant- Business Analyst, Model N, Princeton, NJ, Primary responsibilities focused on translating (end user/sponsor) contract management requirements into the contract software suite for implementation., Translated contract management requirements into software implementations, ensuring seamless integration and functionality., Led the implementation of contract software suite, enhancing operational efficiency and compliance., Collaborated with end users to gather requirements and provide tailored software solutions, improving user satisfaction rates.
• 02/01/08, 08/01/10, Senior Study Analyst (Finance & Resourcing), Hoffman La-Roche, Nutley, NJ, Responsibilities included clinical trial resource management, project and resource allocation management, data analysis, data administration, and assessment for utilization across five therapeutic areas. Managed the super-user/gate keeping responsibilities for project variable costs budgetary forecasting and reporting tool., Managed clinical trial resources and project cost forecasting, ensuring optimal allocation and utilization across five therapeutic areas., Directed project and resource allocation management, enhancing efficiency and effectiveness in clinical trial operations., Conducted data analysis and administration, providing critical insights for budgetary forecasting and resource planning.
• 05/01/05, 02/01/08, Commercial Contracts Associate, Novartis Vaccines & Diagnostics, Emeryville, CA, Administered and managed all GPO based contracts and financial issues for the vaccines division of Chiron Corporation | Novartis Vaccines and Diagnostics. Internally promoted to lateral position within Novartis Consumer Health. Duties included contract management and administration, chargebacks, admin fee payments, and market share analysis., Led contract management and administration, chargebacks, and admin fee payments, improving efficiency., Conducted market share analysis, contributing to strategic decision-making and business growth.
• 10/01/03, 05/01/05, Reimbursement Counselor, Lash Group, San Bruno, CA, Conducted basic consulting and research services in MAP/PAP programs for indigent patients. Concurrently managed the distribution process for MAP/PAP drug delivery., Conducted consulting and research services for patient assistance and medical assistance program for indigent and underserved patient populations. Led the launch of MAP/PAP services for Abbott’s HUMIRA.