- Manages Quality Systems Department, acting as a Site Process Owner for deviations, CAPAs, CCs, Quality Risk Management and inspection readiness.- Oversight and execution of internal audits (ASQ-CQA certified) per corporate and regulatory requirements.- Designated as the Primary Table Lead for Regulatory Audits (FDA, EMA, Health Canada) and Corporate Audits.- Collaborates with Regulatory Affairs for correspondence with FDA and Regulatory agencies including BPDRs and recalls.- Acted as the Recall Coordinator for Voluntary Class II Recall of Commercial Products from the US. - Worked cross-functionally with Executive Leaders within Quality, Regulatory Affairs, Pharmacovigilance, and Legal.- Aids in strategy development by presenting critical site findings to the Executive Leadership team.- Supported the site in implementation of a new fill-line, PPQs, and product tech transfer.

- Managed the Production Compliance department for execution of site-wide deviations, CAPAs, CCs, and SOPs to ensure quality and on-time project delivery. Implemented strategies that resulted in significant process improvements that resulted in the Rockville site leading the enterprise in on-time record closures.- Supported the site in implementation of a new high-speed fill line, PPQs, and product tech transfer.- Trained employees site-wide on deviation and technical writing, root cause analysis, problem-solving, interviewing techniques, CAPA development and project management.- Authored the Site Contamination Control Strategy (CCS) for multiple fill lines in response to Annex 1 Compliance through cross-functional project management. Managed site modifications / process changes and risk assessments in response to identified Annex 1 gaps.- Represented organization at 2023 PDA Mastering Deviations Workshop as Speaker (Speaking Topic: Mastering Deviations: Digging out of the Backlog). Presentation reviewed strategies to overcome a backlog of deviations while maintaining quality and compliance standards. - Developed / delivered site-wide GMP and data integrity trainings.- Authored critical deviations, CAPAs, change controls, and risk assessments.

- Oversaw Operational Quality Department, managing three value streams (5 products) across two buildings.- Managed and developed a new team of 7 direct reports providing 24/7 coverage in support of production operations.- Developed strategy, clear operational plans, and a 5-year quality improvement plan for the department.- Proactively influenced the value stream by interpreting regulatory policy, overseeing production, and providing CGMP and compliance guidance for 20+ regulatory markets.- Approved GMP-related documentation including Deviations, CAPAs, Change Controls, SOPs, and Technical Reports.- Delivered / Developed training on data integrity in conjunction with Data Integrity Lead.

- Managed a team of 5 Investigative Specialists, ensuring on-time closure of quality notifications and supporting the production schedule to achieve target site objectives.- Led problem-solving efforts for systemic issues impacting the quality systems on site, managed conflict, and facilitated deviation discussions across departments when necessary.- Trained new Investigative Specialists on deviation and technical writing, root cause analysis, problem-solving, interviewing techniques, CAPA development, and project management.- Drove strategy to reduce a high-volume of deviations through project management, developing new processes, and leadership. Led and trained a group of 20+ Managers and Site Leaders on root cause analysis, problem-solving, and effective CAPA development. - Acted as the site Excellence in Deviation Management (eDM) Champion, handling the implementation of eDM at Rockville site while reviewing and approving as production for deviations.Collaborated with cross-departmental teams to ensure on-time Lot Release, including product at risk of stock-out.- Authored critical deviations and CAPAs.

- Supervised production compliance department and training employees on deviation and technical writing, root cause analysis, problem-solving, interviewing techniques, project management, and CAPA development. - Planned and coordinated projects and managed and oversaw timelines for all deviations to ensure timely closure and on-time lot release.- Managed Quality Risk Management of the site, accessing current risks, as well as leading risk assessments for new processes. - Developed/Designed the Veeva system for the global enterprise as the Rockville site's representative in the Business Continuity Project, playing a key role in creating / validating the Global Deviation Management process within Veeva.- Presented deviation and risk management metrics during monthly Quality Review Meetings and weekly to Senior Leadership Team.- Worked with Regulatory Affairs and SLT to determine regulatory impact and wrote BPDRs and FDA correspondences in conjunction with Regulatory Affairs Management.- Led cross-functional root-cause analysis and problem-solving sessions- Investigated product complaints- Represented the organization for deviations during FDA and Corporate audits.

- Perform investigations for non-conformances, environmental excursions, and utility excursions utilizing root cause analysis tools, risk assessments, and trending.- Identify, initiate, and execute CAPAs in response to investigations.- Acted as a LIMS (DLIMS) administrator, supporting new processes and process improvements as well as daily maintenance.- Aided in implementation and transition of acquired site for Quality Control group.- Supported validation of Quality Control environmental monitoring and Quality Control analytical equipment.-Manage and participate in cross-functional teams with departments such as Manufacturing Sciences, Quality Assurance, Validation, Facilities, Engineering, Metrology and external groups.- Produce annual and quarterly trend reports for cleaning validation studies-Train personnel on investigations and create investigation guidelines for Quality Control group-Create, edit, and review department Memos, SOPs, guidelines, work instructions.-Perform environmental monitoring, utility monitoring and analytical testing-Review sampling and testing results for accuracy and compliance

-Created and conducted experimental plans both independently and as a group.-Reported results to principal scientist and assisted in determining paths forward.-Performed statistical analysis of testing results including: t-test, z-test, chi-squared, and ANOVA.

-Assist graduate students and post docs on projects-Work on independent experiments and research-Maintain cell cultures and create cell media-Microscopy: bright field, phase contrast, fluorescence microscopy, interference reflection microscopy, confocal microscopy, post microscopy photo processing and photo analysis-Statistical analysis: T-tests, Z-tests, Chi-Square test, ANOVA, tukey post hoc, simple and multiple regression.