Manages the Process Owner Network. Provides support managing controlled processes and the systems used to create and store process data. Oversees systems and processes that maintain the R&D business process framework and documentation standards. Business Process Owner of the Electronic Document Management System (EDMS) for R&D. Assist with management of the BPE SharePoint sites. Process management including ownership, documentation, monitoring, and improvement. Responsible for quality control checking (QCing) and processing documentation updates. Participate in special projects as needed and coordinate the work of contractor/FSP staff as required.

Provides support managing controlled processes and the systems used to create and store process data. Oversees systems and processes that maintain the R&D business process framework and documentation standards. Business Process Owner of the Electronic Document Management System (EDMS) for R&D. Assist with management of the BPE SharePoint sites. Process management including ownership, documentation, monitoring, and improvement. Responsible for quality control checking (QCing) and processing documentation updates. Participate in special projects as needed and coordinate the work of contractor/FSP staff as required.

As a member of the Global External Quality (GEQ) department, I am the primary Quality contact for onboarding new assets and executing transactional activities related to quality operations and CMO management. Core responsibilities include but are not limited to product/process transfers, scaleup/validations, product disposition, exceptions (deviation, CAPA), change control and risk management. I collaborate with multiple internal and external functions to ensure compliance with cGMP regulations and Biogen QMS. I also lead and support continuous improvement initiatives related to Biogen’s QMS and procedures for CMO oversight.Additional responsibilities are described below:Oversee quality aspects of GMP activities for product manufactured at a Biogen CMO. Manage the QA interface with manufacturing partners to ensure on-time compliant manufacturing.Provide technical and quality support for manufacturing operations, deviations management, change management, risk management, and investigations.Responsible for quality aspects related to tech-transfer, scale-up and process validation as it relates to unit operations for the manufacture of product.Perform functions and make decision consistent with cGMPs, Good Distribution Practices (GDP) and Biogen's quality governance. Ensure that the CMOs maintain quality systems that are in the state of compliance.Perform risk assessments in response to product/quality system failures, investigations and regulatory inspections.Provide Quality expertise to influence and support decisions across the Biogen Supply Chain.Support internal audits, external audits of CMOs and regulatory inspections at CMOs as needed.Leads matrix teams and drive projects as it relates to external quality and supply chain operations.Organize and participate in Quality Management Review meetings at CMOs.Draft, negotiate and maintain Quality Agreements with CMO.Collect and perform trend analysis for KPIs for quality operations.

In the Quality Systems and Support group, I hold the global role of Business Process Owner (BPO) for internal exceptions and CAPA. I provide support for TrackWise including daily user issues, verification of training and approval of TrackWise access, and review and approve all changes to internal exception and CAPA records. I ensure compliance of exceptions/CAPA procedures against regulatory intelligence updates and on a site and corporate level. I develop and deliver training and determine process improvements to the procedures and practices for exceptions and CAPA. I also review metrics, provide management with requested reports and information from TrackWise.Other job responsibilities I perform include QA review and approval for deviations, CAPA, global change controls, document updates in the electronic document management system (EDMS), issue batch records, solution records, logbooks and labels, and support inspections.

In the Quality Systems and Support group, I hold the global role of Business Process Owner (BPO) for internal exceptions and CAPA. I provide support for TrackWise including daily user issues, verification of training and approval of TrackWise access, and review and approve all changes to internal exception and CAPA records. I ensure compliance of exceptions/CAPA procedures against regulatory intelligence updates and on a site and corporate level. I develop and deliver training and determine process improvements to the procedures and practices for exceptions and CAPA. I also review metrics, provide management with requested reports and information from TrackWise.Other job responsibilities I perform include QA review and approval for deviations, CAPA, global change controls, document updates in the electronic document management system (EDMS), issue batch records, solution records, logbooks and labels, and support inspections.

I am a self-motivated, dedicated and knowledgeable Quality Assurance professional with over 21 years of experience with a global biotech company. I have demonstrated strengths in leadership, written, and verbal communication, organization, and time management. My commitment to teamwork while also working independently has been recognized by managers, peers, and clients as I am detail oriented and able to collaborate with cross-functional and global teams.My first 5 years in the industry were in the Bioassay lab where I performed in-process, release, and stability testing. Since then, I have moved into Quality Assurance and held different roles, greatly expanding my knowledge and experience in the industry.I have several years of experience in the following areas:Investigations Quality Management SystemsRoot Cause Analysis and CAPASOP Development and ReviewProcess ImprovementsGMP, GLP, CFR, FDA, ICH, EU RegulationsElectronic Document Management SystemRisk Evaluation and Mitigation Strategies (REMS)Regulatory (PAI, Biennial) and Internal Audits

Provided QA support for Manufacturing including QA on the Floor, deviation/CAPA review/approvals, master batch record development/review/approval. Also processed all site SOP and form revisions. Site contact for electronic document management system (MasterControl) for documentation and training.

Main areas of responsibility included:•Reviewed manufacturing investigations for GMP and technical compliance•Reviewed executed batch records for completeness and compliance•Collaborated within project teams throughout project lifecycle•Reviewed manufacturing investigations, ensuring alignment with industry standards and site requirements•Identified and implemented effective corrective and preventive actions.•Participated in Quality “On the Shop Floor” initiatives•Prepared and report metrics•Performed QA release for equipment and rooms•Established and reviewed standard operation procedures•Provided support for QA Management for project readiness and disposition activities•Provided support for client and regulatory inspections, as requested•Other duties as assigned

Performed Quality review and provided Quality insight for Manufacturing deviations, investigations, root cause analysis and CAPAs. Released raw materials for site use.

Provided Quality oversight for Tysabri® REMS program. Reviewed and approved investigations for REMS program, site investigations, root cause, CAPAs, planned exceptions, environmental monitoring alerts/actions, multi-site change requests, validation plans, and reports. Effectively led REMS program which ensured compliance with FDA regulations to effectively monitor product infusion sites and patient status. Improved communication and efficiency between Quality and Patient Services departments. Collaborated with global Quality and multi-site customers on change request for over 40 instruments. Reduced number of open change requests for project from 60 open events to 1 open event. Led control room during regulatory and partner audits to ensure all requests were filled and submitted to auditors in a timely manner Trained investigators on writing investigations and performing root cause analysis to provide guidelines for accurate problem solving and corrective action/preventive action creation Established department’s core curriculum and reduced required training for Quality associates and management by 20%

Performed review of GMP documents (master production records, solution records, standard operating procedures, work instructions, item specifications and forms) in the electronic document management system (EDMS). Actively participated in support roles during regulatory and partner audits. Led QA Documentation responsibilities for product campaigns and projects by attending tech transfer meetings, distributing work assignments and tracking documentation progress to ensure timelines were met for new product campaigns Created and implemented new EDMS document type for work instructions and developed associated procedures for global company use Simplified and increased efficiency of the control room for regulatory and partner audits bycreating roles and responsibilities which resulted in the reduction of the number of personnel involved Created and conducted training for electronic document management system for multiple sites. Trained over 150 oral solid dosage facility new hires and Quality department on electronic document management system and procedures. Collaborated with global QA Documentation groups to harmonize and establish QA documentation roles and responsibilities for document review

Performed cell-based potency assays and antibody ELISAs for in-process, release and stability samples using GMP/GLP and aseptic techniques. Assay leader for potency assays, which included scheduling testing and performed troubleshooting for assay issues Performed assay reagent qualifications and performed assay standard and control trending Prepared media and maintained multiple cell lines Authored protocols, quality technical reports, standard operation procedures, and forms for laboratory validations, qualifications, and procedures

Performed antibody ELISA using GMP/GLP and aseptic techniques. Performed cell-based potency assay for release, finished product and stability samples Created and revised standard operating procedures and forms for laboratory use Maintained laboratory document manuals