Angela Faist
Greenwood,IN
Summary
Results-driven Pharmaceutical and Bio-device Quality Professional with extensive experience in clinical operations, specializing in oncology and neuroscience studies (Phases I-IV). Skilled in FDA regulations, ICH guidelines, GCP, and GMP, with proven success in managing complex global trials and ensuring compliance. Expertise in leading large teams, designing training programs, and conducting internal audits. Highly experienced in inspection readiness, including FDA and EMA inspections. Strong leadership in clinical trial management, quality assurance, and regulatory compliance.
Quality management professional with robust experience in driving process improvements and ensuring compliance with industry standards. Skilled in root cause analysis, auditing, and quality control methodologies. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability, problem-solving abilities, and effective communication.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Global Trial Manager
ENDOCYTE-NOVARTIS
09.2019 - 11.2023
- Led RLT Phase III registration trial, resulting in FDA and EMA approval
- Managed global trials across Canada, Germany, France, Denmark, Australia, UK, South Africa, and Puerto Rico
- Developed training materials and study tools; guided teams throughout the trial lifecycle
- Reviewed over 23,500+ documents (GDP Good Document Practices)
- Implemented a plan that reduced an 18-month backlog
- Managed eTMF team in ensuring document accuracy, classification, and compliance with ICH/GCP guidelines
- Conducted quality reviews of study documents to maintain compliance and integrity
Senior Clinical Quality Associate
ENDOCYTE-NOVARTIS
11.2018 - 09.2019
- Designed and implemented inspection readiness training for clinical trials
- Conducted feasibility assessments of CROs and vendors, ensuring alignment with quality standards
- Supported quality audits and managed follow-up actions for compliance
Quality Assurance Manager
COOK REGENTEC
05.2018 - 11.2018
- Managed complaints, investigations, and CAPA processes to ensure ISO 13485:2016 compliance
- Audited batch release documentation and validated quality documents for medical and lab devices
- Led root cause analysis (RCA) training and spearheaded product development quality efforts
Senior Consultant/Quality Training and Compliance
CHAUCER LIFE SCIENCES
11.2017 - 03.2018
- Managed quality training system implementation, ensuring regulatory compliance for rare disease treatments
- Refined audit preparation processes, focusing on inspection readiness and gap analysis
Associate Consultant/Medical Quality Representative
INVENTIV HEALTH
09.2015 - 10.2017
- Led ongoing risk assessments and quality improvement initiatives across clinical trials
- Developed quality plans and managed deviations, ensuring compliance with FDA and ICH guidelines
- Collaborated on global audits and inspections, contributing to CAPA and root cause analysis
Manager of Quality, Training and Compliance
INVENTIV HEALTH
09.2009 - 08.2015
- Transformed training processes from paper-based to electronic systems, achieving zero audit findings
- Audited training files and maintained training compliance metrics, ensuring FDA readiness
- Supported internal audits and regulatory inspections, and managed CAPA systems
- Project Manager, Global Product Safety
- Data Manager, Oncology Lead
Education
Master of Health Care Administration -
Purdue University
Bachelor of Science - Health and Wellness
Purdue University
Skills
- Audits & Assessments
- CAPA
- ETMF
- GxP
- ICH Guidelines
- IMPACT
- Inspection Readiness
- MasterControl
- MedDRA
- Project Management
- Risk-Based Monitoring
- TrackWise
- Deviation Management
- Vendor/CRO Management
- Quality Control
- ISO Standards
- Clinical Development
- Clinical Research
- Performance Metrics
- CRF
- IRBs
- ICFs
- Change Records
- Root Cause Analysis
- Investigations
- TransCelerate BioPharma
- Veeva Vault
- Database Quality Review
- Cross-functional Collaboration
Certification
- FiTour: Personal Trainer
- FITA: Group Fitness & Aqua Fit Instructor
- ASFA: Cycling Instructor
- NETA: Group Fitness Trainer
- Indiana University: Medical Center Patient Care Assistant/CMA
- Purdue Northwest: Certified Nursing Assistant, Medical Terminology
Community Service
- Girl Scout Leader: Led multiple troops, earning top awards.
- Director of Fitness Ministry, Greenwood Christian Church
- Fundraiser Committee Member and Parent Volunteer, Greenwood Christian School
- Classroom Parent Leader, Southwest Elementary School, Greenwood
- Chairperson, 'People's Choice' Award Fundraiser
- Purdue Alumni Association
- Homeowner Association Board Member
- Community Volunteer, Northeast Elementary School, Greenwood
- Epilepsy Foundation of America: Fundraiser Chairperson & Advocate
Timeline
Senior Global Trial Manager
ENDOCYTE-NOVARTIS
09.2019 - 11.2023
Senior Clinical Quality Associate
ENDOCYTE-NOVARTIS
11.2018 - 09.2019
Quality Assurance Manager
COOK REGENTEC
05.2018 - 11.2018
Senior Consultant/Quality Training and Compliance
CHAUCER LIFE SCIENCES
11.2017 - 03.2018
Associate Consultant/Medical Quality Representative
INVENTIV HEALTH
09.2015 - 10.2017
Manager of Quality, Training and Compliance
INVENTIV HEALTH
09.2009 - 08.2015
Master of Health Care Administration -
Purdue University
Bachelor of Science - Health and Wellness
Purdue University