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Work Background
Delitala Quality Consulting & Author CorporationBusiness Owner
Aug. 2024
Avidity Biosciences, Inc.Associate Director, Quality Systems & Compliance
Jan. 2024 - Aug. 2024San Diego, California, United States
Kite PharmaGlobal Head of Training & Quality Risk Management
Jul. 2023 - Dec. 2023Global Governance role having oversight of the global programs for Personnel Qualification & Training and Quality Risk Management.
Kite PharmaAssociate Director, Global Quality Systems
Jan. 2022 - Dec. 2023California, United StatesKite Business Lead and Project Manager dedicated to implementing and replacing a quality management system (Project Label: Next Generation Quality Management System - AKA Next Gen QMS). ● Phase 1 Implemented the Risk Management modules. ● Phase 2 Implemented modules for Laboratory Investigation Record (LIR), Deviation, CAPA, Effectiveness Check, Change Control, Product Complaints, Issue Escalation, and Regulatory Notification Assessment (RNA). ● The final phase, Phase 3 is near final. ● Led and influenced Kite indirect reports known as global program leads with an end goal of an integrated quality management system ensuring each module takes into account regulatory requirements for drug substance and immunotherapy products as well as the customer experience. ● Gilead Core Team Member and advisor for Next Gen QMS. ● Business Process Owner of the Kite QMS and decision maker on topics related to the Kite QMS such as events and changes.
Kite PharmaAssociate Director, Global Quality Systems, Kite, a Gilead Company, Santa Monica
Dec. 2021 - Jun. 2022Santa Monica, California, United StatesInterim Functional Quality Head of the Quality Management System Extended Global Quality Leadership Team & Global Quality Systems & Compliance Council participant as an advisor for variable quality and compliance events requiring consultation or decisions. Global Change Control Review Board (GCCRB) Chair endorsing global changes to be initiated and implemented at the enterprise level for drug substance and immunotherapy products of five manufacturing plants. Global Program Owner for Deviation, CAPA, Root Cause Analysis (RCA), Effectiveness Verification, Change Control, Quality Management Review (QMR), and Executive Quality Management Review (EMQR). ● Completed a Global Metric Control Plan metric improvement effort for QMR & EMQR. BioNTech transition Quality Lead
Led a team of direct reports through continuous improvement initiatives: ● Established QMR as a global quality program at five kite sites. ● Enhanced the Deviation program by implementing a risk based approach to classifying deviations.
Kite PharmaSenior Manager, Global Quality Assurance
Aug. 2019 - Jun. 2021Santa Monica, CATransformed the Deviation/CAPA/EV QMS To be fit for purpose by obtaining voice of the customer feedback and seeking to understand operations: ● Deviation: Expected cost savings of >$500,000 annually by implementing a first of its kind Web Based Training (WBT) replacing an Instructor Led Training. ● CAPA: Implemented multisite evaluation process intended to prevent cross-site variation and redesigned instructor led training to ensure training effectiveness of CAPA. ● EV: Implemented a risk based approach to determine when an EV is required with the intent to require EV for moderate to high risk event. ● Established QMS field entry guidance documents for Deviation/CAPA/EV to standardize entries improving consistency of review and approval. ● RCA: Implemented a standardized global procedure for RCA and investigation summary templates to improve consistency of investigations and maintain Regulator rapport. Trained >500 Owners/QA approvers at 7 sites, globally. ● Set precedent in delivering effective training virtually at the onset of the covid-19 pandemic to ensure business continuity. Ideated >40 Tableau metric reports with Data Analytics which might have a cost savings of >$100,000 annually for staff who previously had to manipulate data from excel downloads.
Next Gen QMS SME & Team Member.
AmgenSenior Manager Quality & Compliance
Apr. 2019 - Aug. 2019Thousand Oaks, CA
AmgenQuality Systems Site Process Owner for Deviation, CAPA, and Change Control
Nov. 2014 - Apr. 2019Thousand Oaks, CACore Team Member that implemented an Artificially Intelligent (AI) Spotfire tool to trend deviations.
● Tool was implemented into IT in 8-weeks and took first place in the 2018 Quality Innovation Awards. ● Presented a poster and demonstrated the use of the tool at the Amgen AI Symposium.
Core Team Member to Transform the QMS: ● Implemented a new process that allowed product to be assessed ahead of RCA.
Site Trend Program Owner and Author of Monthly and Quarterly Trending Reports. Instructor of Deviation Training and RCA Training: ● Trained over 2000 personnel (many locations) 2014-2019. Quality process health presenter at QMR. Presenter for the QMS at Regulatory Inspections and Audits (Partner & Internal).
AmgenSenior QA Specialist & Clinical QA Safety Lead
Jan. 2013 - Oct. 2014Thousand OaksThe primary responsibility of this position is to provide QA oversight to three clinical, early phase, small molecule (SM), drug substance (DS) active pharmaceutical manufacturing (API) production facilities that produce a variety of small molecule products. One of these facilities resides in Cambridge, MA. This is an individual contributor position designed to be the sole provider of QA oversight. The Senior QA Specialist is equivalent to a Senior QA Manager except that the Senior QA Specialist does not have direct reports. Responsibilities include work order review and approval, batch record review and approval, disposition of products, QA review and approval of qualification documents, certificates of analyses, deviations, CAPAs, change controls, standard operating procedures and product expiry forms (initial & reevaluation). Responsibility also includes informal audits of manufacturing and testing areas and tracks observation mitigation to completion. The Safety Lead position leads safety efforts for clinical QA and chairs the Clinical QA Safety Committee. In this role, I develop and implement safety roles and responsibilities, goals, job aids, and process flow diagrams. The position is responsible for tracking, trending, and reporting safety metrics towards progress to safety goals.
DendreonQuality Assurance Supervisor - Quality Systems
Mar. 2011 - Jan. 2013Seal Beach, CaliforniaSupervisor of a Quality Assurance Quality Systems team that had the primary responsibility of assisting deviation (non-conformances, exception reports) and CAPA authors in completing thorough deviation investigations for a commercial biologics vaccine / therapeutic in a facility that operates 24/7. Additional responsibility includes metrics setting, planning and reporting for deviations, CAPAs, and change controls. Supervisory responsibility includes goal setting, training, coaching, and evaluating performance of the team.
Emergent BioSolutionsQuality Assurance (QA) Supervisor - Quality Commercial Operations
Oct. 2008 - Mar. 2011Lansing, Michigan AreaSupervisor of a Quality Assurance Operations team providing support and oversight for all commercial operations of a 24/7 biologics vaccine manufacturing facility. Supervised three QA teams made up of Raw Material review & disposition, intermediate vaccine manufacturing review & disposition, product filling review & disposition, and final product review & disposition. Primary responsibilities included hiring, scheduling, goal setting, training, coaching, and evaluating performance of the team. Ultimately responsible for all batch record review & disposition activities for commercial product. Solely responsible for final product approval of disposition & distribution. Other primary responsibilities included QA review and approval of standard operating procedures for raw material testing, preventive maintenance on systems and equipment, manufacturing SOPs & batch production records and Quality Assurance Operations standard operating procedures. Responsibility also included QA review and approval of draft and executed validation / qualification protocols for fermentation vessels, media qualifications, analytical systems, biological safety cabinets (laminar flow modules), air handling units, cold storage units (2-8°C to CryoUnits) and other systems. Trained, tried, and proven Escort for Team Biologics biennial inspections. Tertiary responsibilities: QA reviewer and collaborator on intermediate and final product vaccine deviation investigations, CAPAs, and change controls. Non-conformance (commercial reject dispositions) report author.
Emergent BioSolutionsQuality Assurance Quality Systems Change Control Lead
Apr. 2007 - Oct. 2008Lansing, Michigan AreaIndividual contributor position leading two indirect reports dedicated to managing the quality system change control process for a commercial biologics vaccine. The primary decision maker determining change requirements pre and post implementation as well as review and approval of all change implementation. The “Lead” position considered to be first level of management. Primary decision maker determining validation / qualification requirements for equipment / system changes. Drafted validation assessments and determined appropriate change approvers for each change control. Chaired change control review board meetings. Established weekly change control reports for site management visibility. Participant in Quality Management Review. Collaborator on Annual Product Review report. Quality Assurance reviewer and approver for Material Review Board. QA reviewer and approver for change management system governing the LIMS system. QA reviewer and approver for change management system governing enterprise resource system (SAP) changes. Validation representative and decision maker for contract filler conferencing. Implemented a change control cycle time reduction project decreasing average cycle time for most change controls to less than 100 days. Led a change control process improvement project to streamline the change control process. Established monthly, quarterly and annual change control metrics retroactively and current. Established key performance indices and alert level limits.
Emergent BioSolutionsQuality Assurance Quality Systems Deviation Investigation & CAPA Specialist
Oct. 2004 - Apr. 2007Lansing, Michigan AreaTeam member of a Quality Assurance Quality Systems team with the primary responsibility of assisting deviation (non-conformances, exception reports) authors in completing thorough deviation investigations for a commercial biologics vaccine. Responsible for project managing and facilitating a range of 20-30 deviation investigations in a business week. Finalized approximately 350 deviation investigations and 5 formal investigations. Instructed department specific, campus wide deviation writing class. Created and implemented a Deviation Specialist Training Program. Third generation vaccine request for proposal team member. Denison survey (Organizational Culture) committee team member. Appreciative Inquiry Initiative team member. Revised several SOPs within the Quality Assurance department. Team member in a Six Sigma “Increase Production Days” project. Train the trainer qualified. Tertiary responsibilities included: Reviewing batch production records of commercial product material. Physically dispositioning commercial product material. Provided QA oversight of final vaccine filling procedures at contracted filling company.
Greer LaboratoriesQuality Control Vaccine Lead
Dec. 2002 - Oct. 2004Lenoir, NCPart of a small Contract Manufacturing Organization (CMO) type environment responsible for the manufacture of early and late phase clinical trial biologics vaccines for prostate cancer, SARS, Marburg, and HIV. Multi-faceted role with primary responsibility as a Quality Control Vaccine Lead. Secondary responsibilities included task completion in Quality Assurance, Document Control and Manufacturing. The “Lead” position was considered to be the first level of management. Primary responsibilities: Responsible for all in-process and final release clinical product testing performed in BSL-3 conditions. Vaccine filling. Phase-contrast, fluorescent, and bright-field microscopy. Bioburden testing by membrane filtration. Sterility testing by direct inoculation. Mammalian tissue culture techniques (Maintenance, Expansion, Electroporation). Agarose and polyacrylamide gel electrophoresis. Immunofluorescence and cytopathic effect assays. Gram staining and micro-identities. ELISA assays performance results reporting for Anthrone, and Human Serum Albumin. Extensive record keeping and GMP/GLP documentation. Authored SOP’s and forms for to standardize lab procedures. Responsible for all sample handling and sample distribution. Trained personnel on assays, tissue culture, and gel electrophoresis. Preparation of reagents and materials for QC testing and manufacturing processes. Responsible for QC materials, reagents, and sample inventories. Tertiary responsibilities: Quality Assurance: Deviation investigations. Review and approve draft Batch Production Records and SOPs prior to execution. Review of executed batch production records. Manufacturing: Assist in the manufacture of vaccines in BSL-3 conditions; gown qualified Document Control: Final review and archival processes.
U.S. Army (USAMRIID) - Bacteriology Division & Clinical LaboratoryQuality Control Laboratory Technician Bacteriology Division & Phlebotomist Clinical Laboratory
Jul. 1995 - Jul. 1999Enlisted individual obtaining numerous accolades during time of enlistment for Quality Control Laboratory technician and phlebotomist work, volunteerism, and drive to obtain greater rank. Promoted from Private to Non-Commissioned Officer (NCO: Sergeant) in a little more than two and a half years. As an NCO managed, trained and completed performance evaluations for 5 – 15 direct reports. Managed as many as 30 indirect reports. Primary laboratory responsibilities: Worked in Biosafety Level conditions (BSL-2 and BSL-3) performing all work employing aseptic techniques. Performed agarose gel electrophoresis. Performed recombinant DNA techniques and subcloning procedures. Obtained dark room experience in taking gel photos and isolating DNA fragments. Spectrometer experience to gauge concentrations of DNA and optimal densities of cell cultures. Performed plasmid preps, both mini and maxi, and chromosomal DNA preps. Made agar plates, including antibiotic selective plates and yeast selective plates. Prepared media for and grew E. coli and yeast cultures. Performed DNA extractions, enzyme ligation reactions and ELISA assays. Maintained lab supplies and equipment. Performed routine phlebotomy, ran CBCs, UAs etc. plus data entry. Maintained laboratories in accordance with applicable cGLP.
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