Led 7 direct reports and 200+ salaried and hourly employees across multiple QA teams, including 503B In-Process QA, BFS In-Process QA, Packaging QA, Visual Inspection, Warehouse QA, and Batch Release, to drive quality assurance initiatives and improve operational efficiency.Spearheaded a comprehensive transformation of quality processes on the shop floor, introducing real-time data monitoring systems that significantly improved compliance and response times to production issues.Navigated complex regulatory landscapes by leveraging in-depth industry knowledge to prepare the team for successful audits, leading to positive outcomes with minimal corrective actions.Fostered a culture of continuous improvement by mentoring junior staff and developing a training “heat map,” ensuring consistent growth and alignment with company quality goals.Enhanced communication between production teams and the executive quality board by translating technical observations into actionable insights, leading to improved decision-making and faster resolution of discrepancies.Drove innovation in batch record review processes by integrating new technologies that streamlined data collection and analysis, improving accuracy and reducing time spent on manual verification.Collaborated with cross-departmental teams to tackle quality-related challenges head-on, ensuring all regulatory and operational hurdles were addressed proactively.Elevated team performance through hands-on leadership and process optimizations, shaping a more agile and responsive QA team that consistently met production goals.

Played a pivotal role in leading a team of supervisors and salaried employees across multiple quality assurance functions, driving operational improvements, and ensuring alignment with corporate and regulatory standards. Took immediate action on the shop floor, assessing potential deviations and leading swift corrective actions, successfully managing product, equipment, and facility holds to maintain operational flow.Partnered closely with the Quality Control team, acting as an in-process QA expert for laboratory activities, streamlining microbiology and chemistry testing, and enhancing GMP compliance across all materials and utilities.Directed the comprehensive review of batch production records and QC documentation, ensuring raw material and batch disposition processes were thorough and compliant, significantly reducing errors.Provided strategic oversight of the entire GxP documentation lifecycle, introducing process improvements that simplified logbook and SOP management while ensuring compliance with site protocols.Championed the establishment of validation and qualification programs, aligning them with corporate standards and regulatory guidance, enhancing the facility’s operational readiness and compliance posture.Led key facility start-up initiatives and supported technical transfers, seamlessly managing routine activities across laboratories, manufacturing, maintenance, and warehouse operations, ensuring readiness for production scaling.

Managed compounding, sterile filling, maintenance, and warehouse operations, leading a team of 3 supervisors and 10 hourly employees. Oversaw all scheduling, production runs, and staff management, ensuring efficient manufacturing processes and compliance with safety and quality standards.Directed the review of manufacturing records and cleaning logs and ensured all documentation was complete and accurate, improving audit preparedness.Led efforts to mitigate safety and quality incidents, implementing corrective actions and preventing recurring issues.Supported product development by overseeing the introduction of new products, optimizing engineering runs, and driving operational efficiency in product launches.Played a key role in maintaining compliance with cGMP standards, ensuring smooth production runs and adherence to regulatory requirements.

Promoted to lead quality operations across three shifts, overseeing teams in shop floor quality, lot disposition, CAPA, and material sampling/release. Took charge of complex operational challenges, transforming processes and driving efficiency across manufacturing and packaging operations.Pioneered the implementation of a new SAP ERP system, revolutionizing the way quality master data was managed, ensuring seamless procedural updates, and providing comprehensive training to streamline operations.Introduced innovative logbook designs that significantly reduced the number of logbooks in use, simplifying room cleaning and equipment tracking and improving overall operational efficiency.Directed the sampling and quality release of critical materials, including API, excipients, and packaging components, ensuring compliance with rigorous quality standards and contributing to smoother production runs.Oversaw the thorough review and approval of all production batch records and lot disposition, ensuring that finished products met stringent quality and regulatory requirements.Led quality impact assessments for production change controls, minimizing risk and ensuring that adjustments were made without compromising product quality or compliance.Employed a new Acceptable Quality Limit (AQL) procedure, enhancing in-process inspection and sampling and ensuring alignment with corporate policies, leading to improved product consistency.

Recruited to lead a team dedicated to managing QA investigations and CAPA, overseeing the review and approval of all deviation investigations and corrective actions. Drove process innovations that transformed the organization’s approach to quality investigations and compliance.Led the overhaul of the change control and investigation platform, seamlessly transitioning from an outdated system to the cloud-based TrackWise Digital, creating a more efficient and transparent process for managing investigations and CAPAs.Developed three new SOPs to support the go-live of the new system, ensuring smooth adoption across departments and training over 100 cross-functional employees, empowering teams to understand the system’s impact on their roles and processes.Created and implemented key site performance indicators for Quality Management Review, enhancing the organization’s ability to monitor trends and improve decision-making in response to deviations and CAPA-related inquiries.Engaged directly with the FDA to navigate inquiries related to CAPA and investigations, strengthening compliance and reinforcing the organization’s commitment to quality and regulatory excellence.

Promoted to lead the QA Investigations and CAPA team, driving critical reviews and approvals of deviation investigations and corrective actions. Fostered a proactive approach to risk management and quality assurance that transformed operational outcomes.Developed a Quality Metrics Dashboard and TrackWise Reporting tool, enabling real-time monitoring of metrics and improving the organization’s ability to respond to quality issues efficiently.Increased on-time closure rates for deviations and CAPA from under 85% to over 95% for two consecutive years, solidifying the team's reputation for reliability and precision in managing critical quality challenges.Spearheaded a deviation reduction project that cut nonconformance records by half, demonstrating a commitment to improving product quality and reducing operational risks.Championed the site’s Risk Management Program as the Site Risk Champion, overseeing the maintenance of risk policies and procedures and coordinating risk facilitators to ensure a consistent approach to risk mitigation.

Played a pivotal role in assessing and optimizing quality systems, focusing on reducing nonconformances and improving manufacturing processes to enhance product quality.Led the review and assessment of manufacturing and quality assurance equipment, ensuring compliance with CAPAs, nonconformance management, and preventative maintenance activities, significantly reducing the occurrence of production issues.Provided technical support for evaluating existing equipment and optimizing process designs, resulting in more efficient scaled-up production processes and ensuring consistent quality during in-process and release testing.Collaborated with cross-functional teams to implement process improvements, focusing on parameter optimization and operational efficiency to meet the organization’s high standards for quality assurance.

Advancing one final time within Roche, I was promoted to plan, organize, schedule, and supervise the daily operations activities of a team of 18 multidisciplined nonexempt employees in Galenical Packaging.I supported production scheduling and operating metrics and ensured ongoing compliance with cGMPs and regulatory requirements to achieve unit objectives.On a regular basis I interacted with all team members and support groups to identify process operations problems and to carryout corrective actions, modifications, and improvements.Finally, it was also in my purview to review/approve production packaging orders, investigation reports, product complaint reports, follow-ups, variance forms, calibration reports, and technical services.

After earning yet another promotion, I transitioned to provide technical engineering support for process development, Galenical Manufacturing, Galenical Packaging and Industrial Engineering.This meant that I executed and coordinated projects or work teams to support efficient, cost-effective engineering services in equipment/process development, process changes, and/or modifications.I also led (or assisted in) the execution and approval of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of equipment; equipment and technical problem troubleshooting; implementation of capital expenditure programs; industrial engineering projects.I am also proud that while in this role, I:• Implemented an automated Overall Equipment Effectiveness (OEE) software package usedfor monitoring all Galenical Packaging operations, which resulted in cost savings of ~$100Kand an increase in OEE of 5%.• Redesigned and rolled out a new management control and reporting system that resultedin operational efficiency gains totaling $79K annually.

Following my first promotion within Roche, I assumed accountability for all automation projects and support activities for a mammalian Cell Culture and Protein Purification Production Facility.Within that scope, I more specifically:• Coordinated and delegated the completion of automation tasks and projects with 2 directreports in the automation group.• Led the validation of automated equipment and ensured documentation was in compliancewith all company standards and regulatory requirements.• Prepared validation protocols / reports and lifecycle documentation (URS, FRS, DDS) forall new automation/control systems.• Performed and supported troubleshooting and repairs of control systems; investigatedproblems and coordinated resolutions.• Initiated and reviewed modification changes related to automated equipment to ensurethe equipment remained in a validated state.

When I initially joined Roche as an Engineer, I provided leader support for the operation and maintenance of control systems, ensuring that production process requirements were met with minimal downtime.