Marie Florestal
Morris Plains,New Jersey
Summary
Results-driven and Strategic Quality Professional with extensive experience in Quality Systems and compliance management in the pharmaceutical, medical device, consumer healthcare, and biotech industries. Experienced in implementing robust processes that identify compliance gaps and developing strategies for sustainable compliance to corporate policies and governmental regulations, including FDA, EU, ICH and ISO requirements.
Driven and ambitious change manager dedicated to continuous business improvement focused on enhancing revenue and streamlining business operations. Diligent in driving profit maximization through multifaced business approaches. Extensive experience in solid oral, liquids dosage forms, CMO and sterile manufacturing including, the design and review of validation protocols and validation runs of full-scale manufacturing processes. Managed and restructured departments under consent decree injunctions, FDA-483s and Warning Letter, into GMP- compliant units that met (and exceed) verification activities.
Overview
33
33
years of professional experience
Work History
Sr. Global Quality Consultant
Janssen Pharmaceutical Companies Of Johnson & Johnson
02.2020 - Current
- Responsible for end-to-end quality and compliance processes worldwide and responsible for shaping long-term strategy while focusing on consistent manufacturing and delivery of high-quality vaccine products.
- Oversee organization and implementation of quality standards across global sites to ensure consistent compliance across the JNJ network.
- Spearheading Risk Management & Process Improvement to ensure adherence to manufacturing policies and programs.
- Assisted management in establishing long-term strategic goals related to overall product quality and customer satisfaction levels.
- Developed training programs to enhance employee understanding of quality standards and expectations.
- Maintained up-to-date knowledge of relevant industry advancements, incorporating best practices as appropriate to ensure continued excellence in product quality.
Director of Quality and Compliance
Cambrex
08.2018 - 02.2020
- Managed team of QA and Compliance direct reports to ensure compliance to regulatory and internal standards. This includes responsibility for Manufacturing, Packaging, Validation, Lab Investigations and Conducted root cause analysis of non-compliance systems to meet product supply demands.
- Developed opportunities for improvements in cGMP operations as a part of Continuous Improvement Program.
- Directed the Supplier approval process, including quality agreements, questionnaires, audits, supplier corrective action reports, supplier notices of change. Monitor supplier performance indicators and identify quality improvement opportunities within the supply chain.
- Serves as Management Representative responsible for representing company to all regulatory bodies including registered notified bodies and provide quality trending data to upper management for review.
- Ensures that all suppliers quality performance indicators (QPI) metrics presented to management are in alignment with company requirements and metrics.
- Developed training programs that enhanced employee understanding of quality standards, leading to improved production accuracy and efficiency.
- Drove root cause analysis investigations for customer complaints, implementing corrective actions that reduced recurrence rates and improved client retention.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Directed risk assessment activities during product development phases to prevent potential issues from escalating into costly recalls or lawsuits later down the line.
Sr. Quality Systems Consultant
Immunomedics
11.2017 - 07.2018
- Responsible for developing and maintaining key business relationships with key suppliers regarding product quality.
- Compiled and Prepared Stability granules for BLA submission.
- Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
- Generated reports detailing findings and recommendations.
- Mentored junior consultants, fostering professional growth and building strong team dynamics.
- Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
- Conducted regular reviews of operations and identified areas for improvement.
Sr. Quality Consultant
Radius Health
05.2017 - 11.2017
- Managed GMP Quality Management System including systems for investigations (manufacturing, complaint), CAPA, change management.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Analyzed quality and performance data to support operational decision-making.
- Monitored product standards and quality-control programs.
- Promoted adherence to quality standards by educating personnel on quality control.
- Resolved identified quality issues to improve workflows and meet product demand.
Sr. Quality Consultant
Pharmaceutics International, Inc
04.2016 - 04.2017
- Managed, planned and coordinated quality systems team members.
- Assured compliance to in-house and/or external specifications and standards such as ISO 9000:2000.
- Maintained quality system documentation and updated specific documents to reflect remediation of audit findings and company best practices.
- Provided leadership and quality management oversight for Quality Events Team in the process of conducting root cause investigations, identifying CAPAs and monitoring actions for effectivity.
- Analyzed quality and performance data to support operational decision-making.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Led Quality Events Task Force charged with performing in-depth audit of Quality Events and issue summary reports with identified gaps and remediation plans for FDA and MHRA Observations.
Sr. Quality Systems Consultant
Novartis Pharmaceuticals
10.2014 - 12.2015
- Streamlined internal processes for preparation and submission of Annual Product Reports (APRs) to enhance team efficiency and improve overall project outcomes.
- Mentored junior consultants, fostering professional growth and building strong team dynamics.
- Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
- Implemented best practices to optimize organizational performance, leading to improved operational efficiency.
Sr. Quality Systems Consultant
McNeil Consumer Healthcare
06.2010 - 09.2014
- Developed quality training program to conduct root cause investigations which led to a significant increase in % Right-First-Time (from 35% to over 90%).
- Led and managed process improvement program within External Manufacturing group for quality/compliance issues for Recalls, Field Alerts, Regulatory Inspection observations.
- Managed the consumer complaints team, CAPA system, and document control process which ensured that all consent-decree related commitments for complaints/investigations are on target for successful implementation and completion.
- Developed robust plan for the successful elimination of over 2000 backlog consumer complaints.
- Mentored junior consultants, fostering professional growth and building strong team dynamics.
- Conducted regular reviews of operations and identified areas for improvement.
- Helped meet changing demands by recommending improvements to business systems or procedures.
- Evaluated staff performance and provided coaching to address inefficiencies.
Sr. Quality Systems Consultant
Stryker
05.2008 - 06.2010
- Implemented a process for conducting effective quality systems investigations that incorporates identifying the nonconformance, implementing appropriate containment, identifying the root cause, identifying and implementing actions to correct the nonconformance, and validating or verifying that those actions will work and will not adversely affect the product.
- Provided leadership and direction to site investigations personnel in conducting comprehensive root cause investigations that met FDA requirements.
- Mentored junior consultants, fostering professional growth and building strong team dynamics.
- Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
- Managed multiple deadlines across several businesses to meet dynamic needs of multiple clients.
- Conducted regular reviews of operations and identified areas for improvement.
- Devised and implemented processes and procedures to streamline operations.
Sr. Consultant
Celgene Corporations
07.2006 - 05.2008
- Established a Stability department compliant with regulatory guidances (ICH, FDA, EU) and responsible for meeting stability commitments and submissions for regulatory filings.
- Reviewed analytical data for clinical and commercial release, APRs, method development, and method transfer stability studies. Implemented and managed process for stability investigations and monitored CAPA effectiveness.
- Led quality-based initiatives at both a documentation and process level to optimize stability operations. Ensured continuous improvements of established stability procedures and adherence to new systems/processes.
Sr. Quality Consultant
GSK Consumer Healthcare
09.2005 - 07.2006
- Established an environment of continuous improvement and process control for manufacturing.
- Performed quality systems audits to ensure compliance with industry regulations, identified gaps, areas of compliance risk, and established process improvements for key areas in Lab and Manufacturing Operations.
- Conducted follow-up to GMP Investigations, Planned Deviations, and Change Control, NDA Field Alerts, and QC Lab investigations. Prepared/ Approved Annual Product Reviews (APRs).
- Determined quality department standards, practices, and procedures.
Sr. Consultant
Schering-Plough
06.2003 - 11.2005
- Provided leadership and strategic plan to improve overall site compliance, implementation of key quality metrics, and efficiencies to reduce procedure revision cycle time and deviation reduction.
- Chaired the Documentation Quality Management System Steering Committee which ensured that appropriate Quality Operations systems and procedures are in place for sustainable GMP compliance.
- Developed training materials for Global Pharmacovigilance Standards, Medical and Safety Services (MSS) Corporate Policies and Procedures.
- Evaluated training metrics, identified training gaps, and developed appropriate training curriculum.
- Served as Global Liaison for Pharmacovigilance activities that continually assessed quality policies and procedures and provided guidance and direction for improvement.
- Streamlined key process for entire department by implementing method to improve efficiency.
Regulatory Affairs Manager
Hurley Consulting Group
06.2001 - 09.2003
- Provided leadership and quality management oversight for daily activities of 6 direct reports.
- Actively participated in industry conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs management.
- Integrated nonclinical, clinical, manufacturing and control evaluations, performed data analyses and developed and implemented regulatory strategies.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
Chemist
Ciba-Geigy
05.1991 - 05.2001
- Performed analytical testing of raw materials, active ingredients, and drug products to ensure compliance to specifications.
- Developed laboratory testing programs and data analysis while adhering to SOPs, batch records and work instructions.
- Championed process improvements that led to reduced waste generation, aligning with corporate sustainability goals.
- Managed the daily activities of the Stability department to ensure timeliness of product commitments and ICH and SUPAC guidelines. Ensured that all regulatory guidelines were followed as per departmental SOP and regulatory mandates.
- Evaluated laboratory data for safety and efficacy trends. Worked extensively with Drug Regulatory Affairs (DRA) on Chemistry, Manufacturing and Control submissions to ensure accuracy and compliance. Prepared Annual Product Reviews (APRs), and Change Control reports. Designed stability protocols and commitments for NDA, ANDA, and Post-approval filings.
- Established quality control measures for instrumentation and monitored data quality to operate instrument with control limits.
Education
Master of Arts - Operations Management
Seton Hall University
South Orange, NJ06.1997
Bachelor of Science - Chemistry
Pace University
New York, NY06.1989
Skills
- Risk Management & Process Improvements
- Relationship building and retention
- Policy and Procedure Development
- Performance Metrics Analysis
- Design For Manufacturing
- Employee Relations
- Product Testing
- Management Experience
- Problem Solving
- Strong Leadership
Accomplishments
- Developed & implemented team of QA and Compliance direct reports to ensure quality of drug products, and timely production in order to meet client product supply demands.
- Developed opportunities for improvements in GMP operations as a part of Continuous Improvement Program which led to the elimination of investigations backlog and over 95% Right First Time.
- Developed and deployed business quality metrics for the company, including systems for investigations (manufacturing, complaint), CAPA, change management which resulted in a 90% RFT metric. This resulted in increased customer satisfaction, improved supplier performance, improved design change cycle time, reduced errors, and reduced scrap/rework costs associated with cost of poor quality.
- Supported design, supply chain, and manufacturing organizations; provided resources to assist in the design reviews, new product introduction phase, product/process characterization, process capability studies, and over all component qualification and validation processes
- Established an effective and efficient Quality and Compliance program.
Timeline
Sr. Global Quality Consultant
Janssen Pharmaceutical Companies Of Johnson & Johnson
02.2020 - Current
Director of Quality and Compliance
Cambrex
08.2018 - 02.2020
Sr. Quality Systems Consultant
Immunomedics
11.2017 - 07.2018
Sr. Quality Consultant
Radius Health
05.2017 - 11.2017
Sr. Quality Consultant
Pharmaceutics International, Inc
04.2016 - 04.2017
Sr. Quality Systems Consultant
Novartis Pharmaceuticals
10.2014 - 12.2015
Sr. Quality Systems Consultant
McNeil Consumer Healthcare
06.2010 - 09.2014
Sr. Quality Systems Consultant
Stryker
05.2008 - 06.2010
Sr. Consultant
Celgene Corporations
07.2006 - 05.2008
Sr. Quality Consultant
GSK Consumer Healthcare
09.2005 - 07.2006
Sr. Consultant
Schering-Plough
06.2003 - 11.2005
Regulatory Affairs Manager
Hurley Consulting Group
06.2001 - 09.2003
Chemist
Ciba-Geigy
05.1991 - 05.2001
Master of Arts - Operations Management
Seton Hall University
Bachelor of Science - Chemistry
Pace University
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