Desiree Pritchett
Herriman,UT
Summary
Trusted leader with 20 years experience developing, implementing and managing quality systems designed to ensure continuous production of safe, effective pharmaceutical products. Focused on using training, monitoring and morale-building techniques to maximize employee engagement and performance. Experience stepping into roles and quickly making positive changes to drive company success.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Sr. Manager R&D Quality
Teva Pharmaceuticals
10.2021 - Current
- Collaborated with product development to ensure compliance with the quality management system from concept through approval for development of semisolid drug and drug-device combination products
- Reviewed and approved project documentation, including specifications, protocols, reports, risk management results, equipment/instrument qualification
- Solved complex quality issues affecting project related activities, such as deviations, CAPAs, lab investigations and change controls
- Participated in multiple pre-PAI assessment audits, working with Teva teams to proactively address issues that could derail a product’s regulatory filing
- Leveraged leadership skills to identify deficiencies and opportunities to improve policies, procedures and controls.
- Enhanced team member performance through use of strategic and tactical approaches, motivational coaching and training.
- Recruited and hired qualified candidates to fill open positions.
- Assigned tasks to associates to fit skill levels and maximize team performance.
- Exercised good judgment and decision-making in escalating concerns and resolving issues.
Senior Post Market Surveillance Specialist
Merit Medical Systems, Inc
01.2019 - 10.2021
- Responsible for leading the company’s Global post-market surveillance, EU Vigilance, and FDA Medical Device Reporting activities
- Prepare product technical file documentation for pre- and post-market regulatory filings in compliance with ISO 13485, 21 CFR Part 803, Regulation EU 2017/745 (MDR) and 2017/746 (IVDR), and other regional requirements, including PMS and PMCF plans, CERs and PSURs
- Plan and report post-market clinical studies
- Lead a project to update Risk Management procedures and Risk Management Files to meet compliance requirements of ISO 14971:2019
- Supervised a team that determined and implemented improvements that decreased turn- around time for reporting Vigilance events from 30 days to
- Updated all Vigilance procedures to meet Medical Device Regulation (MDR) EU 2017/745
Quality Engineer III
Merit Medical Systems, Inc
01.2019 - 02.2020
- Responsible for global compliance of risk management and post market surveillance processes to ISO 14971 and MDR requirements
- Wrote all Risk Management and Post-Market Surveillance procedures to meet MDR requirements and created and presented training materials
- Designed templates for risk management resulting in a reduction of time needed to complete and document activities and promote standardization of content
- Documented risk management files for various vascular and other medical devices.
Quality Process Engineer
Nelson Laboratories
10.2013 - 10.2017
- Oversaw the design and execution of technical and quality training programs, drafted responses for internal audit, regulatory audit and customer audit action items and performed root cause analysis for deviation and CAPA investigations
- Designed a training program that decreased overall training time from 16 weeks to 8 weeks
- Implemented a data review process to decrease the time between completion of testing activities and review of data, decreasing quality events
- Developed and optimized processes to improve productivity, product quality and product consistency.
- Participated in internal teams to create, improve and standardize processes and equipment.
- Implemented continuous improvement in processes and materials to improve performance and reduce costs.
- Mentored interns and new hires while monitoring job progress and delegating work responsibilities.
- Developed and implemented best practices, quality assurance standards and project management procedures.
Director, Sterility Testing Services
Nelson Laboratories
02.2011 - 10.2013
- Directed a team of multiple managers, study directors and analysts performing the USP product sterility test for medical device and pharmaceutical products
- Led testing system updates, improving the test turn-around-time from >30 days to 19 days
- Increased productivity of available ISO Class 5 cleanroom space by 60% through implementing LEAN manufacturing principles
- Cultivated and maintained relationships to promote positive work culture.
- Managed staff, financials and key performance indicators to facilitate business operations.
- Guided and motivated staff to drive maximum performance.
- Developed and presented new ideas and conceptualized new approaches and solutions.
- Partnered with staff to create professional development plans to support personal and business growth.
- Planned and implemented strategies to grow revenue.
- Drafted mission and vision statements to outline objectives and motivate employees.
- Successfully improved employment turnover through creating incentive and training programs.
Director, Quality Assurance
Nelson Laboratories
04.2008 - 02.2011
- Led compliance for FDA GMP and GLP and ISO 17025 quality systems and strategic plan for quality improvements
- Contributed to improvements of the Management Review process, created a dashboard to display company and section goals and performance in a more transparent manner
- Created a user friendly and compliant documentation system for deviations and other quality events
Manager, Regulatory
Nelson Laboratories
09.2004 - 04.2008
- Managed personnel and operations of quality system including CAPA, complaints, supplier management, internal audits, customer and regulatory audits, change management, continuous improvement and management review
- Oversaw and initiated improvements to the corrective and preventive action process to decrease time to completion
- Partnered with management and process users to review data, identify trends and improve practices, significantly resolving high-risk quality issues
- Hosted seven regulatory audits including FDA, ISO, and EPA to support customer product approvals and maintain regulatory
Quality Assurance Auditor
Nelson Laboratories
11.2001 - 09.2004
- Performed lab audits, data review, and investigations
- Hosted multiple customer audits per week
- Directed 20-plus internal audits per year
- Worked within a team to review 100-plus packets of data per week
Education
Bachelor of Science - Biology
University of Utah
Skills
- Risk management (ISO 14971)
- Regulatory inspection hosting and audit performance
- Aseptic technique
- Problem solving, root cause analysis, CAPA
- In depth knowledge of FDA and EU regulations
- Continuous, proactive improvement
- Advanced technical writing
- Project Management
- Cross-Functional Communication
- Data-Driven Decision-Making
- Influencing and Negotiating
- Employee Development
Certification
- ISO 13485:2016 Lead Auditor
- Certified Quality Auditor (CQA) | American Society for Quality (ASQ)
- Certified Biomedical Auditor (CBA) | American Society for Quality (ASQ)
Timeline
Sr. Manager R&D Quality
Teva Pharmaceuticals
10.2021 - Current
Senior Post Market Surveillance Specialist
Merit Medical Systems, Inc
01.2019 - 10.2021
Quality Engineer III
Merit Medical Systems, Inc
01.2019 - 02.2020
Quality Process Engineer
Nelson Laboratories
10.2013 - 10.2017
Director, Sterility Testing Services
Nelson Laboratories
02.2011 - 10.2013
Director, Quality Assurance
Nelson Laboratories
04.2008 - 02.2011
Manager, Regulatory
Nelson Laboratories
09.2004 - 04.2008
Quality Assurance Auditor
Nelson Laboratories
11.2001 - 09.2004
Bachelor of Science - Biology
University of Utah
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