Samantha Ahern, Mba (Bishop) Email & Phone Number

Vista, Ca, Us

Providing 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.

Fairfield, New Jersey, Us

Serving 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.

Providing 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.

San 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

San 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

Hoddesdon, 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

Hoddesdon, Herts, Gb

San Diego, Ca, Us

San Diego, Ca, Us

San Diego, Ca, Us

San Diego, Ca, Us

San Diego, Ca, Us

Master Of Business Administration (Mba), Operations And Project Management

Bachelor Of Science (Bs), Biochemistry

Education record