Tracy Mazzola

This role drives ongoing QMS improvement initiatives, oversees quality assurance activities, and provides technical leadership for all quality‑related functions. Maintain, improve, and standardize the QMS in alignment with ISO 13485 and customer regulatory requirements. Lead continuous improvement initiatives focused on risk reduction, process capability, documentation effectiveness, and operational excellence. Lead internal audits, supplier audits, and customer or notified body audits. Ensure that QMS metrics, KPIs, and quality objectives are established, monitored, and communicated. Ensure that all production, inspection, and documentation activities meet ISO 13485, customer-specific, and applicable regulatory requirements. Manage nonconforming product processes including containment, disposition, root cause analysis, and corrective/preventive action. Lead risk management activities using tools such as FMEA, control plans, and process validations. Support equipment qualification, process validation, and ongoing process monitoring. Develop and implement quality improvement projects to reduce waste, improve consistency, and enhance product quality. Drive reduction of scrap, variability, customer complaints, and internal defects. Utilize statistical analysis and data‑driven decision making to identify opportunities for improvement. Evaluate, approve, and monitor suppliers. Conduct supplier audits and lead supplier improvement initiatives. Ensure incoming materials meet specifications. Serve as the primary quality contact for medical device customers, supporting audits, documentation and regulatory requests, and complaint investigations. Lead the creation and submission of PPAP/FAI/qualification documentation as required by customers. Communicate quality performance, improvements, and issue resolutions clearly and professionally. Supervise, train, and develop quality technicians, inspectors, and support staff.

• Responsible for the safe and effective processing of medical isotopes used to diagnose and treat diseases. • Oversee incoming raw material inspection through finished product release including COA review and approval. • Oversight for the review of documentation for regulatory compliance (e.g., validation protocols and reports, analytical methods, batch records, corrective action). • Approved documents in support of any microbiological testing performed or data generated. • Report monthly quality performance metrics to Senior Management. • Ensure laboratory procedures are developed, implemented, validated, and maintained in accordance with Good Laboratory and Good Documentation Practice Standards. • Ensure site and QA team members are appropriately trained. • Implemented and managed GMP compliant Quality Management System. • Manage site Risk Register. • Ensure audit readiness, facilitate and support Internal, Customer and Regulatory Audits. • Track completion of audit observations and associated corrective actions. • Responsible for Supplier qualification program including investigation and corrective action. • Liaison for Customer Quality and Regulatory interactions. • Establish and maintain Quality Agreements and related regulatory documents. • Responsible for Customer complaint program, including investigation and reports. • Ensure computer system validation, Part 11 compliance for GMP systems. • Hire, manage, and develop personnel.

• Develop and facilitate changes to SOPs, policies, training materials, and other documents of a technical discipline. • Mentor co-workers and internal customers on quality and regulatory requirements (e.g., NRC, cGMP, GLPs), SOPs, and guidance documents. • Assist in the development of quality policies and procedures. • Recommend and assist in the implementation of modifications on existing quality or production standards to achieve optimum quality within limits of equipment capability. • Perform supplier and contractor qualification assessments as assigned. • Prepare and revise submissions to regulatory agencies and/or customers. • Follow relevant procedures and instructional documentation and applying regulatory/quality guidelines/requirements when performing documentation assessments. • Oversight of the construction contractor’s QA/QC activities. • Perform internal quality system assessments as an assessment team member. • Execute annual assessment schedule events as assigned. • Develop assessment plans, assisting with the performance, and reporting of assessment results. • Prepare status of findings and corrective actions. • Provide a support role as QA representative during regulatory agency assessments. • Develop and provide QA training requirements for current and new employees. • Maintenance of electronic and hard copy records.

• Develop and implement quality systems compliant to 21 CFR Part 820 and Part 11. • Support the development of new medical devices by ensuring compliance to 21 CFR Part 820 and 11. • Monitor and trend product performance. • Assist in identification of noncompliance, root cause analysis of problems and documenting and assessing effectiveness of corrective actions. • Assess and analyze the QMS for efficient compliance to regulations on a periodic basis and provide results and recommended strategies. • Support internal functional partners and ensure process owners are trained and educated in the areas of the quality system regulations as applicable to their area(s), including annual training on QSR requirements. • Conduct periodic audits and plant walk-throughs to ensure compliance to FDA’S QSR regulations. • Review and approve validation plan and reports. Ensure validation activities comply with ISO9001, 21 CFR Part 820 and 11. • Develop and perform software validation protocols in compliance with regulations and write validation reports. • Communicate with other departments on quality and compliance issues. • Participate in vendor, customer, registrar, and regulatory audits. • Lead quality and process improvement projects. • Prepare, revise, and implement relevant SOPs related to the QMS. • Review and approve product and process deviations. • Review batch documentation and perform product release for regulated products. • Conduct supplier audits. • Maintenance of records (training, calibration, etc.)

• Manages, leads, and conducts audits (customer, external, and internal). Includes risk assessments, scheduling, preparing documents, creating records in TrackWise, and managing audit during execution, and closure. • Lead preparations for planned Health Authority Inspections. • Lead of site Supplier Review Board. • Support and implement Central Supplier Quality initiatives. • Coordinate and respond to Supplier Audit Responses. Discussion observations with site leadership to determine or evaluate corrective actions and responses and ensure compliance. Tracks and reports on implementation of corrective actions. • Lead investigative teams for supplier non-compliance and/or disqualification. • Support adherence to Supplier Audit Plan. • Manage and address Supplier Notifications of Change. • Support supplier assurance budget adherence and tracking. • Maintain site Approved Supplier List. • Ensure quality compliance and cost effectiveness of the supply chain. • Assist QA Managers with data/metrics for Corporate Review, Management Review, and Annual Product Reviews. • Coordinates and responds to Audit Letters/Observations to prepare Response Letters. Discuss observations with site leadership to determine corrective actions and responses and ensure compliance across site. Tracks and reports on implementation of corrective actions. • Identify Quality Systems gaps using process mapping and other applicable tools. • Develop and implement risk based corrective measures that are compliant with international regulations. Communicate gaps and corrective measures to the site to gain alignment and buy-in. • Serve as a back-up for multiple Quality Systems functions. • Develop training materials related to Quality Systems. • Train site personnel on Quality Systems issues and procedures, including audit readiness. • Develop, gather, and trend metrics related to audits. • Develop procedures as needed. • Maintain effectiveness of the Quality System components relevant to this position.

• Primary quality liaison for clients and internal customers. Subject Matter Expert for the client products, processes, and requirements. • Serves as support member for product/processes which may not have a specified QA Customer Service representative. • Support internal, client, and regulatory audits through coordination and/or leadership of the audit backroom and may begin to support in-room activities. • Maintain systems and procedures to monitor the health of the quality system and show an awareness of their clients manufacturing floor areas audit readiness 24/7. • Perform statistical analyses and providing metrics for the Quality team to Management on a routine basis. • Responsible for the maintenance, development, and nurturing of the client partnership to ensure alignment and consensus. • Coordinates functions of internal QA organization with customers and necessary departments including reviewing and closure of investigations, reviewing and approving change controls, reviewing and coordinating audit tasks, reviewing, and driving corrections, evaluations, and effectiveness checks. • Maintains client data set including metrics, trackers, business review material and client updates to Leadership Team. • Interfaces with Catalent Operations Groups and Customer Service departments to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure quality standards and regulatory compliance. • Coordinates key systems for their clients including Customer Complaints, Change Control, Inventory Control, Batch Records, and other functions impacting the Quality areas related to assigned products and clients. • Supports Catalent Quality Compliance Department during FDA and other agency inspections as well as Customer and Internal Audits. • Interfaces with other departments to ensure compliance with SOPs and cGMPs via observation of existing processes and implementation of continuous improvement initiatives.

• Coordinates overall operation of the Catalent quality Assurance function as related to specific assigned products and customers. Serves as analytical and technical QA resident expert. • Develops and supports departmental strategic goals for Catalent to assure the highest quality standards and regulatory compliance. Primary quality liaison for clients and internal customers. • Supports client audits through back room support. • Maintains systems and procedures to monitor the health of their client deviations. • Responsible for the maintenance, development, and nurturing of the client partnership to ensure alignment. • Coordinates functions of internal QA organization with customers and necessary departments including reviewing and closure of investigations, reviewing and approving change controls, reviewing and coordinating audit tasks, reviewing, and driving corrections, evaluations, and effectiveness checks. • Maintains client data set including metrics, trackers, business review material and client updates to Leadership Team. • Interfaces with the Catalent Operations Groups and Customer Service departments as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure quality standards and regulatory compliance. • Coordinates key systems for their clients including Customer Complaints, Change Control, Inventory Control, Batch Records, and other functions impacting the Quality areas related to assigned products and clients. Interfaces with all other department to ensure coordination and compliance with SOPs and cGMPs via observation of existing processes.

Quality Assurance: Annual Product Review, Investigations, Audits, CAPA, Receiving Inspection, Label Control, In Process Inspection, Release of In Process Materials, Recalls/Market Withdrawal • Manage Deviations, Investigations, and Corrective/Preventative Actions. • Approve Complaints, Supplier Deviation, and Investigation Reports. • Train all levels of management in proper completion of Deviations, Investigations and CAPA. • Generate and monitor monthly reports to support Global Quality Metrics. • Responsible for the Annual Product Review including the data collection, creation of reports, identification of trends, and presentation to Senior Management. • Participate in Operational Excellence Projects. • Batch Record Auditing • Perform 3rd Party Contract, Intra-Company and External Supplier Investigations. • Perform External Quality Audits. • Placing materials on QA Hold and provide disposition of rejected materials related to supplier investigations. • Provide data upon request and alert the Supplier Assessment Committee of identified trends. • Assist in preparation of documents during regulatory inspections and recalls. • Develop and revise Standard Operating Procedures (SOPs). • Inventory and DEA material control.