Patrick Gondek

Managed a team of 6-9 direct reports with Quality oversight of 25+ External / Contract Manufacturing Organizations (CMOs) of sterile large/small molecule and oral pharmaceutical products and medical devices located in North and South America supplying global markets. Key business partner to External Supply Operations and other enabling functions. Developed multi-year resource planning/allocation and maintained strategic relationships with key CMOs. • Successful new product launches of Paxlovid and Abrilada • Strong relationships with key Contract Manufacturers at a senior site level • Identified, recruited, and developed key talent including • Initiated US ESOQ Diversity, Equity, and Inclusion summer intern initiative • Lead Limited Duration Team for Medical Device and Combination Products (MDCP) • Pilot and rollout of global enhanced inspection readiness program for contract manufacturing audits.

Lead team of 25-30 direct and indirect reports dotted reporting line report to President, US Commercial. Implement and maintain Quality Systems for US marketed products (serialized/lotted devices, and pharmaceuticals) after release from manufacturing sites including Distribution Centers, Public Warehouses, Transportation, Product Release, and Field Actions. Business partner providing quality support for the US Commercial Organization which generated ~70% of Hospira’s annual sales. Continuous improvement and compliance of Global Supply Chain Quality and Global Third Party Manufacturing policies and procedures. • Developed organizational structure including budget and resources for a scalable Global Third Party Quality organization. • Led cross functional effort including the manufacturing site and CDRH to maintain the PCA sterile empty vial on the US market which is a medically and commercially necessary product • Allocated resources appropriately to prioritize product release activities for drug shortage products. • Delivered over 100 Field Actions over 2+ years involving in support of product remediation. • Created a monthly customer specific complaint analysis designed to identify issues isolated to significant US customers and also detect early signals of new quality issues.

Hospira utilized over 80 CMOs for the manufacture of pharmaceutical and medical devices accounting for approximately $1B in annual sales. Lead team of 7 direct reports and responsible for Hospira’s Global Third Party Manufacturing Quality program and Quality oversight of CMOs supplying the US market. • Created a global risk assessment process to evaluate CMO Quality, Business, and Product Risk. Implemented globally at all Regional HQs. Resulted in 30% reduction in annual onsite audits and increased management awareness of business critical product issues. • Hosted “for cause” FDA inspection related to Third Party pharmaceutical products resulting in no 483 observations. • Quality Lead for integration of Javelin Pharmaceuticals, a $145MM strategic acquisition, ensuring all Quality deliverables were met for Day 1 and transition period. • Provided onsite Quality support for successful remediation of FDA 483 and Warning Letter at strategic CMO.

Managed Quality relationships with 12 CMOs accounting for approximately $500MM in annual sales. Managed one direct report and $1.2MM contract lab testing budget. Responsibilities included conducting Due Diligence and cGMP audits, issue escalation/resolution, product release, FDA communication, investigation review/approval, negotiating Quality Agreements, and coordinating new product launches. • Increased customer service levels from 50% to over 90% by actively managing the complex supply chain of the Multi-Vitamin Infusion product line which contributed $25MM in annual sales. • Took initiative to conduct Due Diligence, support product development, and product launch of strategic $50MM Flush Syringe business at an alternate CMO on a compressed timeline. Expedited resolution of critical Quality issues during product launch to maintain customer base. • Developed a formal CMO quality management review process which included developing KPIs to measure CMO performance and identify areas for improvement. Highlighted key CMO issues and developed a communication path to senior management. • Quality Lead for the global integration of CMOs during $2B acquisition of Mayne Pharma. Onboarded products required new quality systems and higher level of oversight compared to existing CMO program.

Quality liaison between Hospira manufacturing sites and One2One contract manufacturing customers. One2One was Hospira’s contract manufacturing business which accounted for approximately $350MM in annual sales. • Negotiated Quality Agreements for One2One products to ensure win-win outcomes. Managed the overall quality relationship between Hospira and One2One customers at the Clayton, McPherson and Austin facilities. • Quality Project Manager for strategic divestiture of Salt Lake City medical device plant to ICU Medical. Responsible for Quality aspects involved in the sale of the plant and the ongoing Quality relationship.

Quality oversight of Hospira’s Pharmaceutical R&D organization including Chemistry, Pharmacy, Microbiology, and Solutions Pilot Plant. • Ensured compliance of R&D organization with Corporate and Regulatory requirements by quality review of operating procedures. • Responsible for the approval of exception documents including deviations, investigations, and calibration OOS.

Provided engineering support to sterilization R&D for new product development and process improvements supporting HPD production facilities on a pilot scale.

Rotational program designed to develop core competencies through the implementation of key projects.