Kristin Schwartzbauer

Experience

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  B. Braun Medical Inc. (US)

  Jan 2001 - Jan 2005

  Quality Assurance
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  Boston Scientific

  Nov 2005 - Jan 2013

  Operations Quality Engineering Manager

  As operations quality manager for Boston Scientific, I directed the largest next-generation top assembly (NGTA) quality organization in Maple Grove producing 120K units per month leading a team of 4 direct reports and 8 indirect reports. Our team oversaw monthly quality and value improvement practice (VIP) metrics, and corrective and preventive actions (CAPA) reporting as well as monthly quality business reviews. We also coordinated PIRs and field action assessments. I served as site lead for IQS ProFicient statistical software implementation. Generated $2M+ annual savings through successful implementation of multiple VIPs.  Supported design transfer and commercial launch activities for Apex (Worldwide), Apex Platinum (Worldwide), Taxus Element (IC), Sterling ES (Worldwide), and Quantum Apex (Worldwide). Facilitated successful audit outcomes during FDA, KEMA, and TUV audits by ensuring compliance preparedness.  Led team to close out FDA warning letter activities related to ToolScope validation in extrusion production area. Instrumental in the successful development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements by identifying and implementing effective process control systems. Show less

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  Wright Medical

  Dec 2012 - Jun 2016

  Senior Manager, Global Quality

  For Wright Medical Group, I directed global quality operations, including establishing and leading global quality initiatives, integration activities, divestiture of key products, and synergizing global quality systems. I assumed ownership of global quality processes for implementation of global ERP system and electronic Product Life Management (PLM), and collaborated with global, cross-functional teams to identify and implement quality system process improvements.  Successfully developed and synergized new operational and business processes involving multiple geographies.  Improved operational efficiencies by automating metrics and ensuring appropriate level of review through harmonized management review. Effectively navigated global, cultural, and ownership issues by developing positive cross-functional relationships.  Assumed ownership of quality warehouse operations to harmonize warehouse quality systems. Show less

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  Antares Pharma Inc.

  Jun 2016 - May 2022

  Vice President, Corporate Quality Assurance

  As head of quality and management operations, for Antares Pharma, I led a team of 26 reports responsible for ensuring compliance with all pertinent FDA, ISO, MDD, and applicable regulations. I oversaw customer expectations governing the development, manufacture, and sale of combination products. My team managed all facets of operations, including risk management, due diligence, data and performance reporting / key performance indicators (KPIs), regulatory inspections, transitional planning for M&A, and talent acquisition and development. Established and successfully executed strategic vision for compliance and quality culture by developing senior quality leaders to ensure compliance for combination products. Successfully led Antares through BSI and DEA audits, and two FDA inspections; ensured consistent state of inspection readiness.  Synergized quality systems across sites reducing redundancy and increasing effective communication. Facilitated the successful launch of five new combination products; provided quality support for review of CMC and clinical documentation for compliance with the appropriate regulations and guidelines.  Significantly improved employee engagement and satisfaction by focusing on talent development and aligning job descriptions, compensation plans, and career progressions to achieve workforce management and organizational goals.  From my initial role as director of quality assurance, device in 2016, I was promoted to senior director of corporate quality in 2017, then again to vice president and head of corporate quality assurance in 2020.SENIOR DIRECTOR, CORPORATE QUALITY | 2017 – 2020 DIRECTOR, QUALITY ASSURANCE, DEVICE | 2016 – 2017 Show less

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  Halozyme, Inc.

  May 2022 - now

  VP, Quality | Head of Quality

  Halozyme Therapeutics, Inc. acquired Antares Pharma, Inc in May 2022.As vice president, head of quality for Halozyme Therapeutics, I direct quality assurance operations as part of an acquired organization where I assumed responsibility for integrating two quality organizations and successfully maintaining business continuity while aligning the organizations for future growth. Since this time, I have doubled staff and currently manage 55+ associates supporting a $700M organization. I collaborate with and present to stakeholders and the board of directors.  Expedited organizational integration and alignment efforts for two quality organizations by creating a leadership team to facilitate vertical alignment of all operations.  Significantly improved employee engagement and satisfaction by focusing on talent development and aligning job descriptions, compensation plans, and career progressions to achieve workforce management and organizational goals. Show less