Shaun Gordon
Pennington,NJ
Summary
Strategic Clinical Quality and Risk Management leader with 15+ years of progressive experience across biopharma R&D, spanning GxP Quality Assurance (GCP, GVP, GLP), Clinical Risk Management, Global Regulatory Inspection Readiness, Vendor Governance, and Biometrics Operations. Proven ability to build and operationalize Quality by Design frameworks, strengthen Quality Management Systems (QMS), and embed risk-based oversight models across global development programs. Deep expertise supporting FDA, EMA, and PMDA regulatory submissions and inspection readiness across hematology, immuno-oncology, and complex development portfolios. Experienced in leading cross-functional study teams, conducting internal and external audits evaluation guidance, driving CAPA effectiveness, developing Standard Operating Procedures and Work Instructions and performing quality due diligence for CROs and specialty vendors. Recognized for aligning quality strategy with enterprise R&D objectives, influencing senior leadership, and fostering a culture of Quality Excellence, accountability, and continuous improvement within fast-paced biotech and large pharmaceutical environments.
Overview
16
16
years of professional experience
1
1
Certification
Work History
GCP Director Clinical Quality Lead
Kardigan Inc.
Princeton, NJ
03.2025 - 03.2026
- 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 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
- Provides technical, 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.
Associate Director, Risk Management Lead
Bristol-Myers Squibb
Lawrenceville, NJ
11.2020 - 03.2025
- 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.
Planning & Execution Lead
Bristol-Myers Squibb
Lawrenceville, NJ
03.2018 - 11.2020
- 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.
Outsourcing Manager
Bristol-Myers Squibb
Lawrenceville, NJ
07.2016 - 03.2018
- 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.
Contracts Manager
Integra LifeSciences Corporation
Plainsboro, NJ
05.2014 - 07.2016
- 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.
Sr. Global Agreements Specialist
Merck (RPS)
Kenilworth, NJ
05.2012 - 05.2014
- 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.
- Prepared, negotiated, and executed domestic and global master agreements, clinical research agreements, amendments, confidentiality agreements, informed consent agreements, facility use agreements, and corporate integrity agreements 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.
Associate Manager: Global Clinical Contracts
Celgene
Summit, NJ
10.2011 - 03.2012
- 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.
Senior Consultant- Business Analyst
Model N
Princeton, NJ
08.2010 - 08.2011
- 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.
Education
Master of Health Administration - MHA
Seton Hall University
South Orange, NJ09-2011
B.A. - Pre-Law
Rowan University
Glassboro, NJ12-2001
Skills
- Quality by Design (QbD)
- Risk-Based Quality Management (RBQM)
- Cross-Functional R&D Leadership
- Change Management & Continuous Improvement
- Inspection Readiness
- GCP / GVP / GLP Compliance
- Clinical Quality Strategy & Governance
- Quality Management Systems (QMS)
- Audit & CAPA Oversight
- Vendor Management & Oversight
- Business Relationship Management
- Global Regulatory Submissions Support
- M&A Due Diligence
- Microsoft Suite (Excel, Outlook, Project, PowerPoint, Word, Access, SharePoint, OneNote, Visio)
- Other platforms: Veeva (eTMF, Quality Vault), Cyntegrity, Clue Points (rudimentary), Tableau Analytics, Share Point, CTMS, SAP, ARIBA, LMS, Concur, RAMP
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
- People management
- Operations management
- Project management
- Team management
- Creativity and innovation
- Strategies and goals
- Project coordination
- Staff management
- Budget management
- Change management
- Issues resolution
- Program management
- Negotiation
- Contract and vendor management
Affiliations
- Nation Contract Management AssociationMember. 2015-present
- DIAMember: 2019-present
Certification
RBQM White Belt CertificationCyntegrityIssued Dec 2020Credential ID d167c80d3af84315be173a2f8666bdef
Timeline
GCP Director Clinical Quality Lead
Kardigan Inc.
03.2025 - 03.2026
Associate Director, Risk Management Lead
Bristol-Myers Squibb
11.2020 - 03.2025
Planning & Execution Lead
Bristol-Myers Squibb
03.2018 - 11.2020
Outsourcing Manager
Bristol-Myers Squibb
07.2016 - 03.2018
Contracts Manager
Integra LifeSciences Corporation
05.2014 - 07.2016
Sr. Global Agreements Specialist
Merck (RPS)
05.2012 - 05.2014
Associate Manager: Global Clinical Contracts
Celgene
10.2011 - 03.2012
Senior Consultant- Business Analyst
Model N
08.2010 - 08.2011
B.A. - Pre-Law
Rowan University
Master of Health Administration - MHA
Seton Hall University