Tammy Burns

• Lead global vendor qualification and lifecycle governance across clinical through commercial operations, overseeing 60+ CMOs, contract laboratories, and GxP service providers to ensure GMP compliance and sustained inspection readiness.

• Establish risk-based supplier classification, re-qualification, and lifecycle oversight strategies aligned with ICH Q9 Quality Risk Management, FDA, and EU GMP standards.

• Oversee end-to-end supplier lifecycle activities within Veeva QMS, including qualification, performance monitoring, and retirement/discontinuation management.

• Lead negotiation and governance of global Quality Agreements, reducing turnaround time from ~300 days to ~100 days through standardized templates and cross-functional collaboration.

• Develop supplier performance metrics and compliance dashboards, leading Quality Management Reviews (QMRs) to identify compliance risks and drive proactive mitigation.

• Implement risk-based supplier audit strategies, reducing audit cycle time from ~150 days to ~90–100 days while enhancing global supplier risk visibility.

• Coordinate vendor management inspection readiness activities, serving as Back Room Lead during FDA and global regulatory inspections and overseeing documentation control and audit support.

• Serve as Subject Matter Expert (SME) for supplier qualification and oversight, directly engaging with regulatory investigators during audits and inspections.

• Support global regulatory readiness for EU commercialization, collaborating with Qualified Persons (QP) and aligning vendor oversight practices with EU GMP and Annex 16 requirements.

• Oversaw QA Operations supporting clinical and commercial manufacturing, including batch record review, lot disposition/release, deviation investigations, and change control governance to ensure GMP compliance and inspection readiness.

• Led end-to-end supplier and vendor lifecycle management with Veeva, including vendor qualification, risk assessment, performance monitoring and vendor retirement.
• Negotiated and maintained Quality Agreements aligned with global GMP requirements.
• Supported inspection readiness activities for PAI.
• Managed lot disposition, deviations, OOS, and change control for global CMOs.

• Oversee clinical and commercial vendor compliance and governance of global Quality Agreements, ensuring alignment with FDA and EU GMP requirements.
• Provide quality oversight of global CMOs, managing deviations, change controls, and lot disposition activities to ensure GMP compliance and product quality.
• Monitor and report supplier performance metrics, driving proactive risk mitigation and continuous improvement across the vendor network.
• Lead cross-functional vendor governance with Supply Chain, CMC, Regulatory, and Quality stakeholders, aligning supplier oversight, issue escalation, and risk mitigation across the global supplier network.

Oversaw GMP batch record review and lot disposition, ensuring documentation accuracy, completeness, and compliance with FDA and EU GMP requirements.

• • Provided quality oversight of deviation investigations, ensuring thorough root cause analysis and development of effective CAPAs to maintain GMP compliance.

• Authored and analyzed Annual Quality Review (AQR) data, finished product testing results, and batch failure trends to identify compliance risks and performance drifts.
• Provided QA oversight to cross-functional data contributors to ensure regulatory alignment and data integrity.
• Developed and presented monthly compliance metrics to senior leadership to support risk visibility and informed decision-making.

• Oversaw batch record review for CMOs and on-site manufacturing to ensure completeness, accuracy, and GMP compliance.
• Provided on-the-floor QA support during engineering runs, performing risk assessments and troubleshooting to mitigate operational issues.
• Reviewed and approved deviations, CAPAs, and change controls, and supported quality system implementation (Master Control) including execution of validation test scripts.

• Served as Functional Metric Review Coordinator, generating and analyzing monthly quality and process metrics to identify trends and drive corrective improvement initiatives.
• Performed executed batch record review to ensure accuracy, completeness, and GMP compliance, and provided QA oversight for minor and major deviations/CAPAs.
• Led value stream mapping initiatives across QA and Manufacturing to streamline workflows, eliminate inefficiencies, and enhance operational performance.

• Promoted through roles of increasing responsibility to supervise manufacturing operations and ensure GMP compliance, including final batch record review and oversight of cleanroom production processes.
• Selected for a cross-functional documentation improvement initiative that streamlined Master Production Records, reducing instruction volume by up to 65% and improving operational efficiency.