Samantha Ahern, Mba (Bishop) Email and Phone Number
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I am an inclusive, innovative, determined, and passionate leader with over 15 years of experience working in regulated clinical laboratory, toxicology, genomics, medical device and pharma companies. I have been a champion for building brand new high performing global teams and processes. My teams have been catalysts of change within organizations allowing for a shift in quality culture to position the companies for ISO certification and FDA registration to gain more market share and product reach. I am passionate about improving operational efficiencies and quality in biotech and healthcare. I formed the first Employee Resource Group (ERG) at my previous org for women’s leadership and mentoring since promoting diversity, equity and inclusion is a passion of mine. I serve in various mentoring roles and speaking engagements to give back and advance women in the STEM community. I strive to create environments where all individuals can thrive and build bridges between groups that never existed previously. Connect XEO Inaugural class of 2022 for Innovative and Diverse Leaders in San DiegoUC Riverside Transformative Leadership Advisory Board MemberISO 13485: 2016 and ISO 9001: 2015 Certified Lead Auditor Medical Device Risk Management ISO 14971-2019 certificate ASQ certified quality engineer since April 2019Lean Six Sigma Green Belt, April 2017Experienced with large scale operational efficiency projects to maximize resource utilization and minimize costs. One of my projects saved the company over $400,000 in hard savings through operational/maintenance costs and over $500,000 in cost avoidance of an instrument maintenance contract. This project optimized capacity on 106 LC-MS/MS instruments, optimized uptime/minimized downtime of these instruments, and implemented a measurement system to track Overall Equipment Effectiveness or OEE of the instrumentation. I led another project to transition from a paper based system of monitoring laboratory occurrences to a fully electronic system which allowed for better tracking/trending of root causes and capability of assessing CAPA effectiveness. 10+ years experience in the following: -Project Management and Quality Management-Building high performing teams-Mentoring/coaching-Working in a regulated environment(CLIA/CAP, ISO 9001, ISO 13485, GMP, GLP, GCP)-Data Analysis, LC-MS/MS instruments, methodology, and troubleshooting-Toxicology, Biochemistry, Genomics, Medical Device, Manufacturing, Quality, Diagnostics2+ years in Business Development of a medical device startup
Quidelortho
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Director Of Quality OperationsQuidelortho Mar 2024 - Present
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Director Board Of DirectorsThe Sun Never Sets Jul 2023 - PresentVista, Ca, UsProviding strategic guidance for a nonprofit with a cause close to my heart, to educate and de-stigmatize addiction and overdose, providing tools and resources to individuals and their loved ones. -
Director At Large MarketingHealthcare Businesswomen’S Association Jun 2023 - PresentFairfield, New Jersey, UsServing on the HBA San Diego board and leading the marketing committee. Collaboration with regional HBA to make an impact both locally and across the global organization. Mentoring/coaching to elevate women in STEM and provide them with a supportive community. -
Founder/ConsultantTwinsight, Llc. May 2023 - PresentProviding insights into building optimal Quality Systems and Operations, building high performing teams, talent development and Retention, promoting diversity, equity and inclusion. Being a catalyst for change to allow for a shift in quality culture to position the companies for ISO certification and FDA registration to gain more market share and product reach. Creating environments where all individuals can thrive and building bridges between groups that never existed previously. -
Director Of QualityBionano Genomics, Inc. Aug 2022 - May 2023San Diego, California, Us● Leading implementation of the QMS (Quality Management System) to align with ISO 13485 and prepare for ISO certification in Q4 2022 and FDA registration of a product ● Defining organizational strategy to build out Quality team for both short and long term and unifying the global Quality vision at all entities Shifting from a research use only to a medical device organization, building out that quality infrastructure, and coaching/mentoring the Quality personnel and cross functional personnel in the transition Building a high performing team ● Training companywide and globally on new QMS processes ● Implementation of Master Control eQMS for Documents, Training, NCMRs, CAPAs, BOMs, Suppliers, Complaints, eMDR and audits ● Implementation of Master Control Calibration and Preventive Maintenance and Mx platform for electronic batch records ● Moving towards being proactive rather than reactive through deployment of Monthly Metrics Review Meeting Series with leadership team ● Rolling out Complaint Review Board, Material Review Board, CAPA Review Board, SCAR Review Board and Supplier Performance Monitoring meeting series for addressing quality issues to optimize and create a more robust QMS ● Initiating the first company employee resource group (ERG) to support women and allies in career development and mentorship along with community outreach Quality Core Team member supporting design and development deliverables for new products Mitigating risk in supply chain through qualification of alternate sources, more rigorous incoming inspection, and quality agreements with vendors -
Associate Director Of QualityBionano Genomics, Inc. Sep 2021 - Aug 2022San Diego, California, Us● Leading implementation of the QMS to align with ISO 13485 and prepare for ISO certification in Q4 2022 and FDA registration of a product Defining organizational strategy to build out Quality team for both short and long termShifting from a research use only to a medical device organization ● Training companywide on new QMS processes ● Implementation of Master Control eQMS for Documents, Training, NCMRs, CAPAs, BOMs, Suppliers, and Complaints
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Sr. Quality Manager Gmp OligoLgc, Biosearch Technologies Nov 2020 - Sep 2021Hoddesdon, Herts, Gb● Providing quality leadership for three ISO 13485 Oligo Manufacturing facilities and ensuring QMS effectiveness ● Implementing CAPA Review Board meetings to improve CAPA timeliness and drive accountability with CAPA process; Reduced backlog of aging CAPAs from 115 to 16 or by >80% in 12 months through collaboration with cross functional CAPA teams to drive CAPAs to completion and ensure effectiveness of actions ● Putting Material Review Board into practice to have stakeholder oversight and control over dispositioning of materials ● Implementing Complaint Review Board to review complaints with all stakeholders to ensure timeliness of complaint resolution and reduce backlog of aging complaints from 50 to 5 or by 90% in 12 months ● Initiating Monthly Metrics Review meetings for site leadership to discuss quality and production metrics, track/trend, and develop corrective actions to address issues when needed— reduced deviations/nonconformances by 40% ● Hosting external audits along with leading and managing internal audit program ● Incorporating criticality assessment and supplier performance monitoring and providing leadership for Supplier Quality Program in unifying 3 sites under one program ● Mentoring and Skill/Talent Development with 12 direct reports● Bringing capacity expansion projects for 3 sites to fruition and ensuring quality is built into the lifecycle of the projects ● Leading labeling project to bring consistency to labeling for 3 sites ● Collaborating with customers and internal stakeholders on change control process ● Implementing change management process for multiple sites to ensure we are meeting the standards/regulations and customer contractual obligations around this element o Holding bi-monthly change review boards ● Creating RMA process ● Steering team member for EtQ implementation project to move to this eQMS within 6 months ● Launching GMP global training for all of the GMP sites within the business -
Quality ManagerLgc, Biosearch Technologies Mar 2020 - Nov 2020Hoddesdon, Herts, Gb
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Senior Manufacturing/Ops Quality EngineerIllumina Aug 2018 - Mar 2020San Diego, Ca, Us -
Quality Systems Specialist/Green Belt Project ManagerMillennium Health Jun 2017 - Aug 2018San Diego, Ca, Us -
Clinical Toxicologist Scientist/Green Belt Project ManagerMillennium Health Aug 2014 - Jun 2017San Diego, Ca, Us
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Associate ScientistMillennium Health Dec 2012 - Aug 2014San Diego, Ca, Us
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Laboratory Technician Lc/MsMillennium Health Jul 2011 - Nov 2012San Diego, Ca, Us
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Laboratory AssistantMpex Pharmaceuticals Feb 2010 - May 2011
Samantha Ahern, Mba (Bishop) Skills
Samantha Ahern, Mba (Bishop) Education Details
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University Of California, San Diego - Rady School Of ManagementOperations And Project Management -
Uc San DiegoBiochemistry
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Ironwood Ridge High School
Frequently Asked Questions about Samantha Ahern, Mba (Bishop)
What company does Samantha Ahern, Mba (Bishop) work for?
Samantha Ahern, Mba (Bishop) works for Quidelortho
What is Samantha Ahern, Mba (Bishop)'s role at the current company?
Samantha Ahern, Mba (Bishop)'s current role is Life Sciences Executive, Board Member, Builder of high performing teams, Connect XEO Innovative and Diverse Leader, Mentor, Identical Twin Girl Mom.
What is Samantha Ahern, Mba (Bishop)'s email address?
Samantha Ahern, Mba (Bishop)'s email address is sa****@****ech.com
What schools did Samantha Ahern, Mba (Bishop) attend?
Samantha Ahern, Mba (Bishop) attended University Of California, San Diego - Rady School Of Management, Uc San Diego, Ironwood Ridge High School.
What skills is Samantha Ahern, Mba (Bishop) known for?
Samantha Ahern, Mba (Bishop) has skills like Laboratory, Lc Ms, Microsoft Office, Microsoft Excel, Data Analysis, Life Sciences, Clinical Research, Biotechnology, Powerpoint, Research, Microsoft Word, Training.
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