JENNY AMISTOSO
Otsuka America Pharmaceutical, Inc.
Fremont,CA
1
Language
1
Certification
16
years of professional experience
Qualified Quality Assurance Leader with proven background in strategic planning and project management. Successfully led cross-functional teams to deliver high-impact initiatives. Demonstrated excellence in stakeholder communication and operational efficiency.
Work History
Associate Director, Quality Assurance/ Senior QA Manager / QA Manager
6 Years 1 Month- Provide strategic leadership and direction as Head of Quality Assurance for the Hayward site, overseeing the Quality Management System aligned with FDA QMSR (21 CFR Part 820), ISO 13485, and combination product requirements (21 CFR Part 4).
- Lead and develop QA/QC teams supporting manufacturing, product release, and on-market product quality for ingestible sensor digital medicine and combination products.
- Establish and maintain QMS effectiveness, including policies, procedures, and quality objectives to ensure compliance with global regulatory requirements.
- Established and maintained QMS effectiveness through development of policies, procedures, and quality objectives, ensuring compliance with global regulatory requirements.
- Lead internal audit programs and host FDA inspections and ISO 13485 audits with successful outcomes.
- Partner with Regulatory Affairs, Device Development, Manufacturing, and Supply Chain to support regulatory submissions, product transfers, and field actions.
- Drove CAPA, deviation, and nonconformance systems with timely investigations, root cause analyses, and implementation of corrective actions.
- Oversee electronic Quality Systems (ETQ), document control, and product complaint handling systems to ensure compliance with Part 11 requirements.
- Reported quality metrics to senior leadership as Management Representative for QMS performance and effectiveness.
QC Manager
3 Years 9 Months- Led Quality Control and Quality Assurance functions supporting digital health and wearable sensor products.
- Built and scaled cGMP-compliant quality systems, enhancing audit readiness and operational efficiency across product lines.
- Collaborated with cross-functional teams to support product development and validation, ensuring smooth software-enabled product lifecycle activities.
- Managed CAPA, deviations, complaints, and nonconformance systems.
- Drove SOP and policy enhancements to align with evolving regulatory and business requirements.
- Supported new product transfer, change control, and validation activities.
- Drove SOP and policy enhancements, aligning quality practices with evolving regulatory and business requirements.
- Represented Quality during FDA inspections and ISO certification audits.
Quality Manager
4 Months- Directed quality systems encompassing CAPA, validation, audits, document control, and calibration to ensure compliance and enhance overall quality standards.
- Acted as Management Representative for regulatory inspections and notified body audits.
- Managed and developed a team of 2 Quality Engineers and 6 Quality Technicians, driving quality initiatives and operational excellence.
- Managed departmental performance, metrics, and budget to align with strategic objectives and maintain operational efficiency.
QC Supervisor
2 Years 5 Months- Supervised QC operations, ensuring thorough inspection, testing, and timely product release support.
- Managed NCMR and MRB processes, facilitating effective resolution of nonconforming materials.
- Oversaw calibration and maintenance of QC equipment, enhancing accuracy of quality metrics reporting.
QA Manager
3 Years 6 Months- Managed CAPA, audits, compliance programs, and SOP standardization.
- Supported R&D and new product innovation initiatives, aligning quality standards with project goals.
- Implemented process improvements to elevate product quality and streamline operational efficiency.
- Managed CAPA, audits, compliance programs, and SOP standardization to ensure regulatory compliance and quality assurance.
Education
Bachelor of Science - Animal Science & Management
Skills
Quality Management Systems (QMS)
Regulatory compliance expertise
Audit experience
CAPA management
Risk management
Software validation expertise
Customer quality assurance
Process optimization
Quality agile practices
Customer feedback
Cross-functional collaboration
ISO 13485 auditor
Accomplishments
Lead the establishment of a new drug bottling and packaging facility, including facility buildout, QMS implementation, and process qualifications.
Certification
Certified Lead Auditor ISO13485:2016
Languages
Korean
Native or Bilingual
Timeline
Associate Director, Quality Assurance/ Senior QA Manager / QA Manager
Otsuka America Pharmaceutical, Inc.
08.2020 - CurrentRead More
QC Manager
Proteus Digital Health
11.2016 - 08.2020Read More
Quality Manager
Viant
07.2016 - 11.2016Read More
QC Supervisor
Cardinal Health
02.2014 - 07.2016Read More
QA Manager
Unilever
08.2010 - 02.2014Read More
University of California
Bachelor of Science from Animal Science & Management
Read More