Carlos has over 30 year's Quality and Compliance experience within the Pharmaceutical, Biotech, and Medical Devices industry. His experience includes Quality Leadership roles in start-ups, mid size, and large companies in pre-clinical, clinical and commercial settings. He specializes in strategic and tactical development and implementation of robust Quality Management Programs including resource planning, budgeting, inspection readiness, and GXP compliance. Carlos has strong experience in managing multicultural quality functions in the US, UK, France, Italy, Ireland, China and Japan including Quality Assurance, Quality Control, Quality Systems, Validation and Auditing in GMP, GCP, GVP and GLPs. He has also managed multiple regulatory inspections, domestic and abroad, including the USFDA, Chinese NMPA, and European authorities. He has supported commercial launches in the areas of oncology and immunology, and has been instrumental in due diligence activities in support of mergers and acquisitions.His current area of focus is in designing Quality Management Programs from the ground up, improving current programs, and in streamlining/restructuring established programs. Carlos has served as VP of Quality in several companies, most recently at Ipsen Biopharmaceuticals, Ironwood, and AZ Therapies, and previous roles of increasing responsibility at Johnson & Johnson, Bristol Myers Squibb, and Cubist/Merck Pharmaceuticals.Carlos possesses a BS in Biological Sciences and an MBA in International Enterprise Management. He resides in the Boston area.

Member of the leadership team reporting to the CEO leading all aspects of the Quality Program including Quality Systems, Quality Operations, and GXP compliance supporting R&D, Technical Operations and Clinical Operations for Lyra's leading Drug-Device combination products. Advising organization on GXP Risk Management, Pre-Approval Inspection Readiness, mitigation, process streamlining and integration.Establish phase appropriate Quality Systems to support Drug-Device Combination Products in clinical studies, and in preparation for commercialization. Establish robust Quality Leadership at in-house and outsourced (CMO) manufacturing of Phase II and Phase III clinical product.Lead and develop Quality Control, Quality Assurance, Quality Engineering, and Clinical Quality functions.Establish collaborative and strong relationships internally and with vendors, suppliers, Contract Manufacturing Organizations (CMOs), and Clinical Research Organizations (CROs)Negotiate and implement Quality Agreements with key suppliers and service providers.Established the Qualified Person (QP) function in the EU.Develop strategic plans to ensure appropriate resources are available to support scaling up manufacturing operations for a biodegradable/slow-release drug device combination product.Hire, develop and retain leading class quality professionals to ensure a mature, technically strong and collaborative quality culture.

Responsible for all Quality and Technical Operations activities including Quality Control, Quality Assurance, Supply Chain, CMC and Manufacturing in support of clinical and commercial programs.Member of the Executive Leadership Team reporting to the CEO.Strategic and tactical activities to ensure compliance with all applicable regulatory requirements.International and domestic supplier relationship management supporting pre-clinical, clinical and commercial programs including product launch and commercialization strategies.

Lead Quality Operations, R&D Quality, Quality Systems and Computer Systems Validation functions, including Inspection Readiness activities in support of NDA submissions and product launch. Perform due diligence activities in support of product acquisitions. Manage outsourced manufacturing (GMP) and clinical (GCP) suppliers and all internal quality functions. Apply risk based approach to ensure GXP compliance, communicate effectively with CEO and leadership team, and apply effective measures to minimize or eliminate company liability.Manage day to day and strategic activities; support CMC, Technical Operations and Supply Chain activities. Focused on patient safety and business strategy and continues improved quality culture.

Head of Global Quality Management Systems, R&D Quality, and GXP Quality Audits. Implementation of corporate governance policies to ensure company wide compliance. Provide leadership and strategic direction to cross functional teams accross the company related to critical areas including improvements to the Quality Culture, ensuring Regulatory Inspection Readiness, implementation of meaningfull Key Performance Indicator, change management, supplier quality management and integrated electronic systems.Provides strategic vision to ensure the organization is set for future success.

Responsible for all Quality Assurance activities including Drug Substance (DS) Active Pharmaceutical Ingredient (API), Drug Product (DP) and Finished Drug Product (FDP) release, Internal and external audit program, and management of Contract Manufacturing Organizations (CMOs).

Extensive experience implementing and managing Quality Assurance and Regulatory Compliance programs that ensure compliance with applicable regulatory requirements, protect company from regulatory actions, and sustain business growth.

Responsible for the quality and compliance programs supporting the Oncology Division including but not limited to ensuring compliance with GxPs in accordance with FDA sections 21 CFR parts 210, 211, 58, 312 and ICH guidelines.

Head of the quality and regulatory compliance programs.Established the Quality and Compliance department including best practices, programs and policies.Implemented best practices for managing contract manufacturers

Harmonized Quality System policies and practices accross multinational operations.Achieved ISO 9000/13485 Certification

Transitioned an R&D function into a fully GLP/GMP compliant businness unitPerformed domestic and international regulatory compliance audits

Addressed Warning Letter 483 observations and cleared Consent Decree Status with FDA