Responsible for execution, maintenance, and continuous improvement of quality system elements including managing the processes for batch document review, product disposition, change control, deviation investigations/CAPA, Complaints, and controlled document lifecycle management

Coordinated global quality system harmonization among four manufacturing sites with separate quality management systems. • Supported FDA and MHRA inspections at three sites. Collaborated with site quality and operations groups to develop responses and CAPA within required timelines. • Updated management review procedures at all four sites to meet ICH Q10 Pharmaceutical Quality System requirements and to standardize metrics and key process indicators (KPIs) across the sites.• Launched global Quality Event Escalation process to ensure senior leadership was aware of critical quality events at each manufacturing location. Completed initial evaluations to assure that scope was correct and affected product was identified. Twenty-five events were escalated in the first two months of the program.• Trained staff on data integrity requirements, good documentation practices, and root cause analysis tools.• Implemented global Specification Setting process to speed product introductions. New process includes relevant groups early on for on time product launches.

Directed all aspects of quality assurance and compliance with applicable regulatory requirements for media products. Worked with QA and Site leadership Team to improve procedures and facilities. Led Quality and Compliance oversight of aseptic processing of Bio therapeutic and Research media including those classified as Medical Devices. • Revised Aseptic Process Simulation (Media Run) program to qualify new aseptic filling processes. These changes allowed for larger approved batch sizes. Reduced number of qualifications from eight to five. Performed risk assessments using risk matrices and FMEA (failure mode effects analysis). • Led site through two FDA inspections; by CDRH in June 2018 and Team Bio in July 2018. Obtained initial ISO 9001:2015 certification and ISO 13485:2003 re-certification in August 2018.o Tracked previous observations and response completionso Coached subject matter experts in presentation skillso Interacted with inspectors to give a consistent positive view of site’s quality system

Managed all quality activities for both vendors and contract manufactures including vendor approval and notice of change evaluation. • Performed audits of manufacturing sites for API (active pharmaceutical ingredient), finished pharmaceuticals, and product contact materials, and contract laboratories. Performed approximately 25 supplier audits each year. • Audited in the United States, Mexico, European Union (EU), India, and South Africa.• Notified the using site and purchasing management of any critical audit findings. Developed risk-based remediation plans for suppliers.• Evaluated and audited IT service providers including Software as a Service for document control, training, and LIMS, as well SAP hosting sites. • Rewrote questionnaires for different supplier types and enacted a process to evaluate FAQ responses against questionnaire requirements.• Created a process to use third party audits and “desk audits” for sites which could not be directly audited. Saved travel costs and improved regulatory compliance. Managed contract audits.• Quality lead for corporate computer integration projects, including SAP, serialization, and relocation of cloud service providers.• Reviewed and approved R&D product and method development protocols and reports

Responsible for all aspects of cGMP for manufacture of sterile pharmaceuticals. Headed the Quality Department of approximately 150 personnel, including chemistry and microbiology laboratories. FDA and MHRA inspections found the site fully compliant. Developed, updated and met budget goals for the department. Worked collaboratively with other sites in the Baxter network to implement corporate policies and procedures that met regulatory expectations and were usable by both pharmaceutical and device manufacturing facilities.

Managed all elements of site’s Quality System to current GMP requirements• Performed audits and annual product reviews• Supervised audits, CAPA tracking, change control, and master batch record changes• Coordinated metrics collection. Prepared quality reports and initiated CAPA for improvement• Hosted FDA, MHRA, and customer audits. There were no FDA 483 observations on my areas

Led QA monitoring production of sterile vials and ampoules in compliance with FDA requirements.• Reviewed and approved Master Batch Records, forms, SOPs, manufacturing investigations, technical services investigations, and training requirements. • Represented QA in all phases of procurement of manufacturing equipment and facilities. QA authority for functional requirement specifications (FRS), validation protocols, and final validation reports.• Supervised two QA Supervisors, two Batch Record Reviewers and one Investigation Scientist. Site was purchased from Wyeth in December 2002.

Increasing levels of responsibility for quality of sterile manufacturing and packaging operations. • Made accept/reject decisions for in-process and finished goods• Updated procedures to improve efficiency and compliance• Approved manufacturing and laboratory investigations