Amanda Whelan Email & Phone Number

New York, Ny, Us

New York, Ny, Us

Foster City, Ca, Us

• Lead the R&D quality training administration, oversight and coordination for Gilead's global R&D organization. • Managing a multi year training simplification initiative across Gilead's global R&D organization• LMS Business Lead; BPO for R&D GxP training• Discovered tech capabilities that automated manual processes • Supports operational aspects of Gilead’s Quality Management System (QMS)• Serves as a lead contact for departmental business processes related to training administration activities, including contributing to cross-functional system / process improvement initiatives• Follow formal Quality Control procedures to assure consistently high-quality output and data integrity• Develop tools to ensure integrity of data and assure high levels of accuracy, quality and consistency• Identify new tools to automate processes and enhance efficiency• Contribute to the generation of quality metrics/reports• Provides quality oversight through review and analysis of records/data for compliance and consistency with procedural and regulatory standards• Deliver training on departmental business processes to cross-functional global groups• Advise customers on applicable policy and standards and partners with functional areas and affiliates to ensure appropriate oversight of the QMS is maintained• Support functional areas and affiliates in preparation for audits/regulatory agency inspections through provision and interpretation of quality metrics and project management of quality deliverables • Provides support during audits and regulatory agency inspections• Represent the Gilead R&D Training function during regulatory inspections• Manage a team of 6 personnel • Responsible for the task management and workload allocation of team members

Foster City, Ca, Us

Manager, R&D Quality.Process, Documentation and Learning.

New York, Ny, Us

• Acted as a quality partner to clinical teams to ensure regulatory compliance (GCP, ICH, CFR)• Developed vendor management and risk management program• Authored procedural documents on: GxP training, SOP on SOPs, risk management including risk register, vendor qualification, management, and oversight • Drove Quality by Design approach to GxPs & non-regulated work activities• Operationalized and delivered QMS initiative outputs in alignment with established milestones• Guided personnel from initial discovery of a deviation (planned and unplanned) to the documentation and closer• Led CAPA discussions, drafted CAPA responses & facilitated RCA sessions• Provided support for GCP audits/inspections - scribe & interviewee • Actively participated in clinical operations & protocol deconstruction meetings• System Administrator of Document Management & Learning Management systems• Established & led the document control function • Onboarded & configured 21 CFR Part 11 compliant Electronic Document Management System (eDMS) • Executed UAT in OQ & PQ validation activities• Led document & record management activities including tracking and review of quality documents, archiving, periodic review, and all other day-to-day administration • Led a process simplification initiative • Served as the SME on eDMS implementation, training materials, processes and tools• Day-to-day administration of TrialSpark’s controlled documents • Learning Management Administration (ComplianceWire & Absorb)• Onboarded learning management system within 2 weeks of start date• Managed the training process, including identification of training requirements, tracking results and monthly reporting of metrics to management• Oversight of role-based training, training matrix, and onboarding training of new hires• Worked with business partners to develop, deploy and continuously improve effective and engaging training curricula for employees• Day-to-day administration of LMS

New Brunswick, Nj, Us

Worked closely with faculty and international program providers to support program coordination from the earliest stages of development - marketing, recruitment, budgeting, enrollment and registration, to post-program evaluation. Advised an extremely diverse student population across all academic disciplines and backgrounds: from first-generation undergraduate students to graduate students looking for programs where they can apply theory to practice.Program Management • Manage growing portfolio of 30 short-term programs during winter, summer and embedded terms; duties include budget creation, contract management, marketing, recruitment, application review, and pre-departure support • Work alongside tenured faculty and Academic Deans to ensure programs maintain both high academic integrity and financial stability • Understand how students interact and engage with Rutgers Global—Study Abroad. Adapt marketing, recruiting, and teaching materials in conformity to this• Partner with Risk Management to ensure complianceAdvising and Development• Work with Rutgers University undergrad, graduate and PhD. students participating in credit bearing short-term & faculty-led study, internships, and service programs abroad• Advise students during all phases of their experience – program search, application, finances, financial aid, curriculum matching, course registration, pre / post acceptance, and re-entry/reverse culture shock • Advocate for students with key university stakeholders. Program Development• Maintain relationships with current oversees and US based partners to develop global learning experiences. • Negotiate with partners to achieve affordable price points for our high financial need student population • Identify trends, gaps, and needs that are missing from current portfolio • Cultivate the creation of new partnerships including site visits, contracts and Memorandums of Understanding (MoUs).

New Brunswick, Nj, Us

Built workforce competencies by promoting the alignment of employer needs, market analysis trends, and workforce skills within the healthcare sector. Established innovative ways to develop and train populations. Advised clients on educational pathways and stackable credentials needed to transition into a Healthcare career. Empowered jobseekers and students with one-on-one services such as -- scrubbing resumes, mock interviews, tests to determine leadership style, and career coaching.* Developed NJ Employer Coalition for Healthcare Workforce Expansion (ECHWE) - North, Central, and Southern, NJ. * Worked with coalition members to create a Regional Plan for NJ Healthcare Workforce* Conducted workforce needs assessment. Results are utilized by DOL/LWD in creating NJ Industry Valued Credential List* Facilitated meetings and oversee performance of all three ECHWE chapters* Liaised between students, healthcare employers, educational institutions, job seekers and NJ Department of Labor and Workforce Development (DOL/LWD)* Developed curriculum and manage training sessions to upskill NJ Health Care workforce* Conducted statewide trainings to discuss NJ DOL/LWD statistics and job outlook projections specific to the healthcare sector. * Managed and update social media accounts and organizational website, daily* Scheduled, arranged, marketed and coordinated design and logistics for events and meetings; including weeklong, annual Health Care Industry Week* Created partnerships between educational training facilities and/or sector specific employers to NJ DOL* Experienced with Drupal

Itasca, Illinois, Us

Managed the planning, development, implementation, evaluation and ongoing administration of child abuse and neglect prevention and care management training programs for Pediatricians, General Practitioners, Residents, Nurses, Social Workers and Early Interventionists. Served as coordinator and training facilitator on statewide programs at over 50 healthcare sites across New Jersey. Responsible for recruiting pediatric providers and CP&P trainers, coordinating training sessions and evaluating effectiveness of programs using quantitative and qualitative measurement tools.* Managed Department of Children and Families’ funded educational programs on child abuse and neglect, Adverse Childhood Experiences (ACEs) and human trafficking* Oversaw work plan and curriculum development, coordination of program deliverables with internal and external partners, and reporting with stakeholders.* Obtained American Board of Pediatrics (ABP) Maintenance of Certification (MOC) Part 4 credit for all eligible QI projects* Successfully managed the recruitment, implementation and ongoing administration of NJAAP’s 6-month MOC quality improvement program to link pediatric healthcare providers with families, public partners and communities.* Developed culturally competent curriculum and evaluation tools to reach diverse populations.* Collected, assessed, and issued monthly feedback on AIM Statements and PDSA cycles* Obtained Continuing Medical Education (CME) and Nursing CE credits from accrediting bodies within the state* Planned and organized events such as webinars, TA calls, meetings and learning sessions; Coordinated guest speakers and related honoraria.* Charged with creating slides on populations vulnerable to Human Trafficking. Slides are now utilized by the NJ Department of Health for statewide training of pediatric providers.* Experienced with Qualtrics

Master Of Public Health (Mph)

Bachelor Of Science (B.S.), Public Health Education And Promotion