Yomara Gomez-Naiden Email & Phone Number

Bothell, Washington, Us

In this role, I will lead the strategic development and operational management of our GXP Quality Systems for early and late-stage development programs. I am committed to fostering a strong culture of quality as we advance our innovative portfolio of targeted oncology therapies, including antibody-drug conjugate therapies (ADCs).

San Diego, Ca, Us

Responsible for overseeing Operations, Quality, Regulatory, and Project Management.

San Diego, Ca, Us

Bothell, Wa, Us

Responsible for setting the overall strategies, directions and tactics of the Corporate Quality function. Responsible for the company quality management system (QMS), Supplier Quality Management, Regulatory Surveillance, Continuous Improvement, Global Training and Inspection Management Program. Led the establishment of the company's first Global Quality Management System, Global Management Review Board, Global Regulatory Inspection Program, and successful integration and standardization of quality systems across acquired sites. Deployed TrackWise Digital, the company's first enterprise GMP IT System and led the integration of quality systems in acquired sites. As Interim VP of Quality in Boulder, was responsible for oversight of the Quality Assurance (QA), Quality Control (QC), Quality Systems, Validation and Regulatory Compliance groups . Ensured the Quality organization had the appropriate infrastructure to support all site startup operations and for establishing the GMP Readiness Plan for the site to be ready for clinical, commercial manufacturing and upcoming regulatory inspections. Achieved GMP readiness and initiation of first commercial batch in less than a year on the job.

Oss, Nl

Company's first Quality hire, Hired to establish the Quality Assurance organization to support a rapidly growing start-up biotech company and implement the Quality Systems required to ensure a successful PAI and product launch. This included the oversight of all activities supporting the development, manufacture, packaging, labeling and release of API and clinical drug product—continually driving excellence in process innovation, quality system deployment, quality oversight, regulatory compliance, and continuous improvement. Successes included implementing critical quality systems (change control, deviations, audits, investigations, metrics, training and others), a quality governance and infrastructure to de-risk and prepare the company for its first NDA submission to FDA. - Established and executed a strategic plan to prepare the company for its first NDA submission and FDA inspection resulting in a successful inspection and FDA drug approval in 4.5 months from submission (accelerated and priority drug designation granted).- Created infrastructure and hired a quality organization of 7 employees to support the development and implementation of a robust quality program and PAI initiatives. - Designed an internal and external audit and supplier qualification program. - Led the successful execution of internal audits and “mock” PAI readiness activities, including supporting AstraZeneca and Third Party vendors with their PAI readiness activities.

Chicago, Us

Recruited based on extensive experience in establishing Quality Management Systems. Tasked with assessing the company’s existing Quality Management infrastructure and to design a new program for the Life Sciences division. This resulted in the establishment of a new Quality Manual (for Life Sciences and Medical Device) and set of Global Policies, Global procedures and Standard Operating Procedures. Led a group of 20 direct reports, in 3 continents, responsible for the management and compliance of key quality management systems including Change Management; Product Quality Complaint; Clinical Deviations; CAPA; Recalls; Post Market Surveillance and GMP Regulatory Updates. Prepared the site for inspections and was responsible for reviewing and approving responses to inspections.

Rahway, New Jersey, Us

Ensured sites met established KPIs and continued to drive Quality and Compliance Excellence through cross-functional ownership. Created a culture of continuous improvement and risk management through the implementation of site Quality Systems. Monitored/audited sites to ensure compliance with established policies and regulatory requirements. Met with global Regulatory Agencies to discuss proposed regulatory changes. Traveled heavily both domestically and abroad to lead Quality Remediation Projects and Audits. Led the Americas Global Network Strategy, responsible for rationalizing and restructuring the company's manufacturing in the Americas Region. Supported Product Sourcing teams and Regulatory Affairs to ensure all Market Registrations changes were updated in a timely manner. Conducted due diligence audits in support of acquisitions, joint ventures, investments and divestitures. Managed 8 Site Quality Network Leads and ensured their timely execution of the transition project plan due dates.- Led quality integration activities between Schering-Plough and Merck. - Successfully led the quality/regulatory aspects of the sale of 2 sites in Argentina and Colombia, as well as the closure of a site in Mexico that helped increase utilization of core strategic facilities to 70%, drove capital reductions of $400MM / year and led to inventory reduction of $250MM / year minimum.

Rahway, New Jersey, Us

Established a new program to manage over 100 Third Party vendors and ensure reliable supply of quality products at a competitive cost—including contract revisions, quality agreements, and execution of audits. Americas Quality Head responsible for ensuring regional sites compliance to the Audit Readiness Program, Quality Systems, Training, Recalls, Complaint Management, Investigations, and Master Validation Program—in addition to other compliance areas. - Recognized as an Internal Subject Matter Expert (SME) on Right First Time/Systems Improvement.- Led compliance remediation activities in Brazil, Colombia, Chile, Argentina, Ecuador, Peru, and Mexico. - Headed quality integration activities between Organon and Schering-Plough.

Rahway, New Jersey, Us

Appointed due to experience working with non-FDA sites to create/implement a new set of Global Quality Policies inclusive of critical international regulatory requirements. Successfully completed project in less than 6 months. Responsible for streamlining existing quality documents and creating a single, centralized document hierarchy to ensure consistency/compliance at all of Merck's FDA and non-FDA regulated sites. Performed internal audits of subsidiaries and supported global sites during Regulatory Inspections. Audited Third Parties and supported Consent Decree initiatives. Managed a staff of 5 Global Quality System Managers and 2 Project Managers. - Head of the Quality Systems Steering Committee, attended by SVP/VPs of all cross-functional areas at Merck.- In less than 3 months, identified the gaps that existed between the company existing standards and FDA, EU, WHO and PIC/s requirements and made the necessary inclusions to the global documents.- Led a Laboratory Efficiency Project in Rathdrum Ireland and Canada that streamlined operations at the site by more than 50% increasing release testing with zero increase in deviations at both sites.

Rahway, New Jersey, Us

Established and led a team of 34 employees to manage the creation and approval of all compliance documents, specifications, standard operating procedures (SOPs), method validations and policies used internationally across all 65 FDA and non-FDA sites.

Stamford, Ct, Us

Recruited due to experience with consent decrees to assess the company’s SOPs and laboratory infrastructure in preparation of their NDA submission to FDA of OxyContin. Responsible for ensuring the company was prepared for upcoming DEA and FDA inspections. Successes included leading the implementation and management of a robust GMP Compliance Program involving a complete redesign of the company's laboratory infrastructure, SOPs and quality governance groups. Formed and managed a new internal Compliance Group of 10 employees to oversee all operations related to documentation, batch release, training, investigations, change management, equipment calibration/validation, vendor certification, CAPA, and stability.

New York, New York, Us

Began career in individual QC role in this leading pharmaceutical firm, responsible for testing stability samples and performing method transfers/validations. Managed operations during FDA consent decree and gained credentials as a Certified Laboratory Safety Officer, GMP Auditor, and HAZMAT Officer.

Master Of Business Administration (Mba) In Pharmaceutical Chemistry

Bachelor'S Degree, Chemistry