Kim Masi

Experienced cGMP Quality Operations Leader with a robust background in both small and large pharmaceutical settings, supporting development and clinical trial supplies from Phase I to Phase IV, and Commercial Products. Previously led cGMP supplier management program and established vendor risk assessment documentation. Proven success in managing review and release teams for IMPs, with expertise in FDA and EU GMP compliance across all stages.

Highly driven encompassing technical skills, QA operations, cross functional collaboration and proactive and regulated solutions.

Associate Director, GMP Quality Assurance at Gossamer Bio (2025-10 – Present)

• Manage CDMO supplier / CDMO performance through quality metrics, and data-driven performance reviews.
• Assess, review and approve all supplier-related quality events, changes, and deviations to ensure compliance.
• QA SME for both analytical and manufacturing operations.
• Collaborate with both internal and external partners teams and stakeholders to manage cGMP Quality requirements and maintain Quality Agreements (QAAs).
• Master Control Documentation, AQEM QMS, quality tracking, and regulatory submission support.
• Release and disposition of Drug Substance for use in U.S. and global clinical trials in compliance with cGMP and regulatory standards.

Associate Director, Quality Assurance Strategic Operations at Arvinas Inc. (2021-12 – 2025-06)

• Led a team of 3–5 in the Quality Operations for API group, overseeing GMP documentation from multiple CDMOs and analytical service providers for clinical supplies including intermediates, Drug Substance, and early Phase IMPs.
• Oversaw supplier / CDMO performance through quality metrics, KPI tracking, and data-driven performance reviews.
• Assessed and managed all supplier-related quality events, changes, and deviations to ensure compliance, thorough investigation, and timely closure.
• Performed quality audits of CDMOs, developed risk assessments of suppliers and all QMS activities.
• Collaborated with external partner QA teams to manage and maintain Quality Agreements (QAAs).
• Utilized Veeva Vault, QMS, and RIM systems for documentation control, quality tracking, and regulatory submission support.
• Released and dispositioned Drug Substance/Product for use in U.S. and global clinical trials in compliance with GMP and regulatory standards.
• Conducted quality reviews of Drug Substance CMC sections for all IMPD/IND regulatory submissions.

Quality Assurance Manager at Curia New York, Inc (formally AMRI) (2019-11 – 2021-11)

• Managed team of 4 full time Quality Specialists
• Managed the Supplier Qualification Program for GMP materials, contract manufacturers, and service providers, ensuring compliance with internal and regulatory requirements.
• Oversaw the development and maintenance of Quality Agreements with suppliers, customers, and subcontractors.
• Performed GMP review and disposition for manufacturing use.
• Acted as the primary QA representative for quality events and Quality Agreement discussions with external partners.
• Administered Quality Systems using TrackWise, including audits, CAPAs, OOS, Events, change controls and complaints,

Compliance Lead at Intact Pharmaceutical of Medinstill LLC (2016-09 – 2018-02)

• Intact Pharmaceutical GMP Quality Assurance Lead for 503B manufacturing area (ISO).
• Collaborated with the technical to ensure user manuals were established for client’s requirements.
• Project managed the implementation of the electronic documentation system.

Senior Manager, External Operations Partnership Quality at Baxalta (2015-06 – 2016-07)

• Provided Quality input and oversight for the life cycle development of biosimilars inclusive of development and manufactured by Baxalta external manufacturing partners.
• Monitored and reported quality performance metrics (KPIs) Key Performance Indicators to track quality systems and performance of Baxalta external manufacturing partners.
• Performed Baxalta batch release of Drug Substance and Drug Product for use in global IMPs.
• Acted as Person in Plant during Manufacture, Fill and Packaging of IMPs

Associate Director of GMP Quality Assurance/Clinical Supplies Release Officer at Boehringer Ingelheim Pharmaceuticals Inc (2010-07 – 2014-09)

Progressed in Roles with increased responsibilities

• Supervised a team of 5 in the Batch Review and Final Release function, overseeing documentation planning and GMP compliance review.
• Appointed Clinical Supplies Release Officer for final QA disposition of US/Non-EU finished IMPs for use in U.S. and global clinical trials.
• Established global collaboration with EU Qualified Persons (QPs) and the Final Release Team to coordinate international trial releases.
• Implemented a Reduced Review process for CMO Batch Packaging Records by 50%

Auditor IV/Review Release Lead at Boehringer Ingelheim Pharmaceuticals Inc (2006 – 2010)

Auditor lll at Boehringer Ingelheim Pharmaceuticals Inc (2001 – 2006)

Auditor ll at Boehringer Ingelheim Pharmaceuticals Inc (1997 – 2001)

Lab Analyst (Commercial Operations) at Boehringer Ingelheim Pharmaceuticals Inc (1996 – 1997)

Bachelor of Science in Chemistry – Western Kentucky University, Bowling Green, KY