DANA BOARON
Los Angeles
Summary
Director of Quality with extensive expertise in GLP, GMP, and GCP environments, specializing in regulatory compliance and quality systems across pharmaceuticals, OTC, and cosmetics industries, backed by robust FDA auditing experience.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Sr. QC Manager
Olaplex
01.2022 - Current
- Lead initiatives to boost Olaplex Quality organization's performance, achieving a reduction in error rates, and improving efficiency.
- Conduct audits on 15+ CMs, leading to 10 corrective actions that improved compliance rates by 30%.
- Proactively report critical Quality Events to the leadership team, enhancing decision-making and response strategies.
- Work cross-functionally with Procurement, Supply Chain, and Packaging R&D to address quality concerns.
- Responsible for 3PL quality activities (trainings, SOPs, inspections).
- Take ownership of quality control, inspection site planning, and team assignments, ensuring rigorous quality control processes and inspection protocols.
- Engage with the R&D department in benchmark testing for new product development, ensuring that quality standards are met from the inception of product designs.
- Responsible for cross-functional training: GMP and SOP trainings.
- Evaluate suppliers through targeted questionnaires, identifying key risks for R&D and Packaging, which improved decision-making efficiency by 25%.
- Review and approve product specifications and line trial reports. Attend line trials and first production runs to ensure the product's quality and integrity.
- Work with contract manufacturers and component/raw material suppliers to address quality events.
- Collaborate with the Customer Success team to reduce consumer complaints through proactive monitoring of adverse events.
- Spearhead the review and approval of CAPAs and SCARs, collaborating with CMs to effectively identify root causes, leading to enhanced investigation efficiency, and improved compliance outcomes.
Associate Director of Quality
ImmunAl, RNA Sequencing
Manhattan
01.2021 - 01.2022
- Served as the quality subject matter expert for laboratory operations, enhancing compliance and training across GLP, GCP, and GMP standards, and supported successful CMC and NDA submissions.
- Assisted the Therapeutics team in achieving 100% compliance in CMC and NDA submissions, enhancing project efficiency.
- Facilitated effective communication of Quality Control (QC) strategies across internal teams and external partners, enhancing compliance by 20%.
- Ensured compliance with regulatory standards by reviewing and revising quality guidelines, resulting in a 20% increase in process efficiency.
- Spearheaded the development and execution of Immunai's QMS, enhancing compliance by 20% through strategic policy implementation.
- Facilitated seamless tech transfer by enhancing supplier qualification and streamlining validation protocols, ensuring compliance with quality standards.
- Spearheaded the Quality Management System, enhancing SOPs and business documents, resulting in a 20% increase in compliance efficiency.
- Led 5 teams to enhance document accuracy by 20% and ensure compliance with internal procedures, streamlining process execution.
- Led cross-departmental initiatives to streamline Deviation, CAPA, and Change Control processes, improving compliance by 20%.
- Spearheaded third-party supplier qualification program, enhancing vendor performance by 20% through stringent evaluation processes.
- Streamlined the review and approval of laboratory documentation, enhancing compliance for 100+ equipment qualifications and quality certificates.
- Spearheaded annual quality training for 150+ employees, boosting compliance through rigorous internal process audits.
- Led the preparation of study files, enhancing compliance and securing positive outcomes in 100% of audits and inspections.
External Quality Manager
The Honest Company
Los Angeles
01.2019 - 01.2021
- Conducted on-site and desk audits for 30 suppliers, delivering actionable QA recommendations that enhanced compliance and overall supplier performance.
- Led 15 investigations with suppliers, effectively reducing quality issue resolution time through targeted corrective actions.
- Led a quality improvement project using Agile methodologies and RACI charts, boosting team efficiency by 30%.
- Conducted comprehensive supplier reviews and risk analysis.
- Led tech transfer quality initiatives, improving product compliance by 30% for new and existing offerings.
- Collaborated with 10+ new suppliers to achieve 100% compliance with The Honest Company's Supplier Quality standards.
- Partnered with Customer Success to decrease consumer complaints through proactive quality monitoring.
Quality Manager
Munchkin
Los Angeles
01.2017 - 01.2019
- Evaluated 15+ cosmetics and dietary supplement suppliers, achieving 100% compliance with regulatory standards.
- Evaluated product designs for compliance with 21CFR and Cal Prop 65, ensuring 100% adherence on over 50 SKUs.
- Facilitated cross-functional collaboration with R&D and Packaging teams, ensuring 95% compliance in tech transfer activities within the Quality Management System.
- Developed comprehensive product specifications and test methods using the ETQ system, enhancing efficiency by 30%.
- Oversaw external lab testing activities, ensuring timely communication and review of reports, improving turnaround time by 20%.
- Conducted monthly and annual cGMP audits at 10+ factories and distribution centers in the US and Canada, achieving 98% compliance with FDA regulations.
- Conducted FDA Regulatory Visit and Inbound/Outbound Inspection training for 30 Munchkin personnel, boosting compliance awareness by 25%.
- Led root cause investigations and CAPA for 50+ consumer complaints, enhancing resolution efficiency by 30%.
- Collaborated with FDA inspectors to provide critical compliance data, enhancing inspection efficiency and ensuring regulatory adherence.
- Completed 40-hour training in SQF, HACCP, and FSMA, enhancing food safety and quality assurance skills.
Process Validation Engineer
Johnson & Johnson (Neutrogena)
Los Angeles
01.2014 - 01.2017
- Manage 10+ protocols and reports, meeting FDA standards for new and third-party transferred cosmetics, personal care, and OTC drug products from different Johnson & Johnson divisions.
- Executed and approved 10 or more validation protocols and reports for Bulk, Filling, and Packaging Validation.
- Ensured compliance with cGMP and safety regulations.
- Leveraged single-use systems for transferring totes and precision testing.
- Orchestrated 5+ projects, delivering comprehensive validation documentation for enhanced manufacturing processes.
- Coordinated contractor and PV personnel activities, achieving on-time project completion rate.
Laboratory Research Assistant
Technion, Israel
01.2010 - 01.2014
- Calibrated and analyzed equipment using HPLC and GC-MS, achieving increase in analysis efficiency for complex mixtures.
- Conducted MATLAB data analysis, increasing sensor sensitivity evaluation efficiency.
- Led optimization testing, resulting and efficiency for product performance and environmental impact.
Sales and Marketing Manager
Scent-Sation- Perfumes and Cosmetics
Los Angeles
01.2008 - 01.2010
- Developed and and implemented innovative marketing and sales strategies.
- Developed and executed a comprehensive marketing action plan.
- Achieved accuracy in financial forecasting, and prepared annual budgets.
- Forecasted regional sales and developed quotas, driving a 15% increase in annual revenue.
- Boosted sales by 20% through strategic planning and execution of targeted advertising campaigns.
- Enhanced relationships with 10 key accounts through monthly visits, resulting in a 15% increase in customer satisfaction.
Education
Bachelor of Science - Chemical Engineering
Technion-Israel Institute of Technology
01.2014
Skills
- Quality Assurance Management
- Quality Auditing
- Root Cause Analysis
- Regulatory Compliance
- Risk Management
- Team Leadership
- Continuous Improvement
- Quality Management Systems (QMS)
- Supplier Quality Management
Websites
Certification
- HACCP Coordinator
- SQF II
- PCQI (Preventative Control Qualified Individual)
- CGMP internal Auditor
- ISO 22716
- GLP
- GDP
Accomplishments
- Munchkin- 2018 Award for #1 Selling Product
- The Honest Company – Initial Public Oering
Timeline
Sr. QC Manager
Olaplex
01.2022 - Current
Associate Director of Quality
ImmunAl, RNA Sequencing
01.2021 - 01.2022
External Quality Manager
The Honest Company
01.2019 - 01.2021
Quality Manager
Munchkin
01.2017 - 01.2019
Process Validation Engineer
Johnson & Johnson (Neutrogena)
01.2014 - 01.2017
Laboratory Research Assistant
Technion, Israel
01.2010 - 01.2014
Sales and Marketing Manager
Scent-Sation- Perfumes and Cosmetics
01.2008 - 01.2010
Bachelor of Science - Chemical Engineering
Technion-Israel Institute of Technology