I author network standards/procedures to define quality governance to be implemented at individual sites, which includes gap and risk assessments with site representatives, to meet corporate goals.I work collaboratively with individual sites to incorporate the network's vision for the biologics and vaccine franchises, ensuring that best practices are harmonized and implemented.I provide technical and quality input for method qualification/validation protocols and reports, stability protocols and reports, specifications and justifications, CMC filing and meeting packages for products in various stages of development, ranging preclinical to commercial.

I represented the interests of the patients, advocating for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for all products sent to patients through third parties, enabling distribution of medically needed products globally.I oversaw all quality aspect of divestment deals, including due diligence and negotiation of contractual terms before and after complete transfer of marketing authorization, resulting in clear and transparent transfer of roles and responsibilities.I negotiated terms and conditions for license, supply, and quality agreements with international third parties to secure mutually beneficial partnerships that adhere to international regulations and local requirements, resulting in financial gains for all business partners and ensuring access to medicine for patients.I coordinated and participated in third party audits of manufacturing sites, both internal facilities and Contract Manufacturing Organizations (CMOs) to identify potential risks for supply interruptions due to Quality or Regulatory incompliance.I partnered with internal stakeholders to create GMP questionnaire for use in assessing compliance of localization companies, ensuring adherence to international GMP standards.I revised Quality Control (QC) qualification process for contract laboratory organizations (CLO) using risk assessments, which resulted in an estimated 2,800 annual hours of savings to the organization.I worked in conjunction with partnering collaborations to identify and classify risks associated with third parties, which included implementation of risk mitigation measures to reduce financial and branding risks.I routinely reviewed and updated internal procedures to comply with company policies/third party contracts/health authority commitments to reduce risk of product supply interruptions or health authority injunctions.

I was the single point of contact for international relationships with third parties for commercial manufacturing and distribution of products globally.I organized, coordinated and hosted third party technical visits per contractual obligations, enabling alignment between manufacturing and testing procedures with third party's dossier.I authored, prepared, and led negotiations relating to quality agreements between Roche/Genentech and third parties or affiliates, resulting in compliance with corporate and health authority requirements.Translated third party requirements, as stated in quality agreements, into controlled documents and trained internal stakeholders, as necessary, to ensure compliance with contractual obligations.I participated in third party audits and health authority inspections, including negotiation of agendas, preparation for audits/inspections, and draft/review of responses, enabling the organization to meet the right to operate criterion.I designed and implemented the third party complaint handling process to enable timely investigation, resolution, and communication of results to third parties, ensuring continued supply of products to patients without interruptions.I collaborated in the successful filing of a Prior Approval Application to update a biological product to a drug/device combination product, revitalizing sales of a mature product.

Responsible for project management of all work performed at US and UK contract labs to ensure deliverables are within project scope, timeline, and budget.Review and approve all protocols and reports generated by contract labs for potential inclusion in US filing.Collaborate with Japanese partners to ensure FDA requirements for an IND application are met, including technical training on current US guidelines.Work with QC analysts to develop an HPLC method to quantify excipients in diluent.Supervise a team of up to 12 QC analysts, who were responsible for testing products to support manufacturing, release, and stability of the product.Write, revise, and review SOPs for laboratory equipments and test method procedures.Generate annual stability reports for FDA submission.Manage, address, and conduct investigations relating to deviations in analytical procedures and Out of Specification results.Responsible for conducting tours of the QC labs and addressing auditor questions in regards to QC procedures.

Supervised and managed six chemists in the testing of drug coated stents.Coordinated and review QC data for compliance/accuracy and investigated atypical data.Approved engineering protocols, analytical development reports, validations, and stability reports for accuracy, clarity, and compliance to company policies and ICH guidelines.Investigated the effects of formulation on release rate of drug/polymer matrix in vitro and in vivo.Reviewed and approved IQ,OQ, and PQ performed by contractors on laboratory equipments.Compiled data and authored a manufacturing technology and analytical transfer of products to a second site. Generated and analyzed data from explanted samples to determine correlation between in vivo and in vitro drug release.

Responsible for the routine testing of commercial products, including all Certificate of Analysis testing. Duties included investigation and resolution of assay issues and atypical results. Collaborated with Critical Reagents team to qualify new lots of controls and references.