Sarah Courtemanche

Focused on advancing strategies for enterprise Quality Systems modernization, operational scalability, data governance, and digital quality transformation within regulated biopharma environments. Areas of focus include: • Enterprise Quality Systems governance and operational scalability • Quality risk management, investigations, CAPA effectiveness, and inspection readiness • Data integrity, process harmonization, and quality performance visibility • Quality Systems modernization and digital quality enablement • Governance considerations for emerging technologies, automation, and AI-enabled quality workflows Actively engaged in industry discussions, regulatory developments, professional learning, and emerging technologies that support the evolution of scalable, data-driven Quality Systems.

Led QA Operations and quality system strategy for RNA therapeutics and gene therapy drug product programs across clinical and commercial manufacturing, ensuring global GMP compliance and inspection readiness. - Built and led a high-performing QA team overseeing manufacturing support, batch record review, and product disposition (lot release), ensuring GMP compliance and timely release of clinical and commercial products - Provided QA oversight across the product lifecycle, including tech transfer, validation, and commercial manufacturing for sterile injectable products, partnering cross-functionally to proactively identify risks, influence decision-making, and ensure compliant, quality-driven outcomes - Maintained quality oversight of CMOs, CTLs, and global vendors by establishing Quality Agreements and supporting audits and performance monitoring (APQRs/QBRs), ensuring GMP compliance and supply continuity. - Drove inspection readiness strategy, addressing regulatory inspection observations with sustainable CAPAs - Strengthened quality systems (CAPA, deviations, change control, investigations) to improve compliance, inspection readiness, and operational efficiency - Championed cross-functional quality initiatives, aligning Manufacturing, QC, Regulatory Affairs, and Supply Chain around quality‑focused operational decision-making. - Developed and implemented risk-based approaches (QRM) to deviation management and product disposition - Led data integrity initiatives, ensuring alignment with ALCOA+ principles and global regulatory expectations - Collaborated directly with Regulatory Affairs and cross-functional stakeholders to gather required source data and perform in‑depth reviews of global regulatory submissions (NDA, BLA, MAA, PSA, AR, CBE), ensuring accuracy, completeness, and submission readiness. - Supported QMS transformation initiatives, including Veeva implementation and workflow optimization

Led a high-performing QA team supporting global commercial distribution across the U.S., Canada, and the EU. Directed end-to-end product lifecycle quality activities, including manufacturing, release, supplier performance, change control, product disposition, design changes, and complaint investigations. Drove regulatory compliance (CAPA, SCARs, MDRs, FDA interactions), supported inspections (FDA, EU, MDSAP), and translated quality data into risk-based decisions and continuous improvements.

Led quality systems supporting commercial product distribution across the U.S., Canada, and the EU. Managed end-to-end complaint investigations, including root cause analysis, reportability assessments, and trend monitoring. Integrated complaint data with risk management and drove CAPA strategies to support continuous improvement and regulatory compliance. Supported inspections and management review through metrics and quality system governance.

Supported the full product lifecycle for hemodialysis products, from development through commercialization. Led design assurance for a peritoneal dialysis system. Defined specifications, conducted risk assessments (FMEA), and cross-functionally supported the development of validation strategies (DQ/IQ/OQ/PQ). Represented Quality in design reviews, design transfer, and change control, and supported the implementation of new manufacturing lines and product extensions.

Led quality oversight for medical device design, validation, and regulatory submissions, enabling successful product development and launch. Drove cross-functional execution of new product development, finished packaging, and process implementation to ensure compliance and scalability.

Led and developed a team of 17 QA staff supporting 24/7 manufacturing operations. Oversaw batch review, product release, investigations, training, and GMP compliance, including cleanroom monitoring, manufacturing support, sampling, testing, inspections, packaging and labeling, and process optimization to ensure consistent quality system execution.

Supported design and validation of automated manufacturing systems and production scale-up. Led QA initiatives that improved delivery performance, reduced costs, and enhanced customer satisfaction. Completed FDA 483 remediation activities, SOP updates, and implementation of statistical sampling plans to support efficient and compliant lot release, and contributed to the implementation of a new electronic Quality Management System (eQMS).

Supported supplier quality management, including selection, qualification, and performance monitoring, and establishment of quality agreements. Partnered with suppliers to define specifications, inspection methods, and quality requirements. Managed corrective actions and supplier-related issues, and supported complaint investigations, audits, and updated quality system procedures.