Open to opportunities

REINA User

@reinauser1

Message

Dynamic Project Manager with 12+ years in quality management.

United States

Message

What I'm looking for

I am seeking a role that values quality and compliance, offers growth opportunities, and fosters a collaborative environment.

I am a dynamic and results-driven Project Manager and Quality Management professional with over 12 years of experience in the pharmaceutical and chemical manufacturing sectors. My expertise lies in establishing and optimizing quality management systems, driving continuous improvement initiatives, and fostering a culture of compliance and excellence. I have a proven ability to lead cross-functional teams and manage complex projects in both onsite and remote environments, committed to enhancing operational efficiency and delivering exceptional quality outcomes right the first time.

Currently, I manage multiple projects at Syensqo, ensuring compliance with quality standards for automotive and medical device regulations. I am accountable for quality improvement initiatives and lab automation systems, overseeing all project phases from initiation to closure. My key contributions include managing corporate quality goals and achieving re-certification as a Lead Auditor. Previously, as a Multi-Site Quality Manager at Dura-Line, I oversaw two Quality Control Laboratories, ensuring compliance with TL9000 and ISO 9001 standards while cultivating a culture of quality throughout the organization.

Experience

Work history, roles, and key accomplishments

Current

QA/QC Project Manager

Current

Syensqo

Aug 2023 - Present (2 years)

Successfully managed multiple projects, including chemical, mechanical, and extrusion molding labs, ensuring compliance with quality standards for automotive and medical device regulations. Accountable for quality improvement initiatives and lab automation systems (LIMS/DeltaV), ensuring timely completion within scope and budget.

Project Management Quality Assurance Regulatory Compliance Budget Management Cross Functional Team Leadership ISO 9001 IATF 16949 LIMS

Multi-Site Quality Manager

Dura-Line

May 2021 - Aug 2023 (2 years 3 months)

Oversaw two Quality Control Laboratories, ensuring full compliance with TL9000 and ISO 9001 standards while cultivating a culture of quality throughout the organization. Developed and delivered comprehensive training programs for facility managers on compliance expectations and quality regulations.

Quality Control TL9000 Standards ISO 9001 Training Programs Data Analysis Performance Monitoring Power BI Employee Engagement

Quality Consultant

Anteris Management & Consulting

May 2021 - Aug 2022 (1 year 3 months)

Provided expert quality compliance support for medical device contract manufacturing, adhering to ISO 13485 standards. Acted as a technical SME during investigations into production deviations, effectively identifying root causes and driving CAPA.

Compliance Medical Devices ISO 13485 Root Cause Analysis CAPA

Manufacturing Supervisor

Takeda Pharmaceutical

Mar 2014 - May 2021 (7 years 2 months)

Supervised daily production, focusing on training, KPI monitoring, and policy enforcement to ensure high quality outputs. Engineered production task schedules to improve efficiency, achieving higher production yields through effective KPI monitoring.

KPIs Process Improvement Product Specification Monitoring Stakeholder Management