Lori Anne Stoepel
Randolph,USA
Summary
Licensed pharmaceutical professional with 15+ years in medication management and patient care. Expertise in pharmacology, prescription accuracy, and regulatory compliance. Demonstrated leadership and analytical skills leading to successful therapeutic outcomes in fast-paced healthcare settings. Effective communicator and team player committed to quality management and business-driven results.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Pharmaceutical Immunization/Medical Consultant
Pharmaceutical
Randolph, NJ
05.2015 - Current
- Achieved patient compliance and reimbursement goals through strategic initiatives.
- Analyzed patient records to identify trends and recommend necessary improvements.
- Facilitated training sessions for medical staff on updated procedures and technologies.
- Conducted risk assessments to identify potential issues in patient care delivery.
- Liaised with external organizations to stay informed on industry advancements.
- Collaborated with healthcare professionals to enhance quality of patient care.
- Managed Rx reimbursement protocols, including third-party and government programs.
- Established global quality systems leveraging 15 years of pharmaceutical leadership.
Pharmacist
Walgreens Boots Alliance
Rockaway, NJ
03.2025 - 06.2025
- Accurately dispensed medications to patients and healthcare providers while ensuring compliance with protocols.
- Reviewed prescriptions for appropriateness, identifying potential drug interactions.
- Educated patients on proper medication use and possible side effects.
- Managed inventory by ordering and restocking pharmaceutical supplies efficiently.
- Administered immunizations and vaccinations following established guidelines.
Director, Global Science Technology and Commercialization: Comm. & Supply Analytical
Merck Manufacturing Division
01.2013 - 05.2015
- Directed ongoing integration of analytical and quality systems across , Ireland; Las Piedras and Arecibo, Puerto Rico.
- Collaborated with Regulatory CMC and Quality for new product introductions, ensuring site inspection readiness.
- Reviewed global submissions and guided responses to Health Authority requests and regulatory observations.
- Assessed proposed CMC changes affecting in-line APIs and drug products for regulatory compliance.
- Implemented integrated analytical and quality systems to support analytical development and supply testing operations.
- Coordinated global efforts to establish Lean Six Sigma operations in Commercialization and Supply Analytical laboratories.
- Established Project Management structures to ensure timely initiative completion and monitor progress.
Pharmacist
Goodrich Pharmacy
06.1996 - 01.2013
- Managed high volume of prescriptions daily while ensuring accuracy and exceptional customer service.
- Cultivated relationships with healthcare providers to improve patient care and medication adherence.
- Educated patients on drug interactions and provided clear administration instructions.
- Collaborated with pharmacy team to develop and apply continuous quality improvement strategies.
- Established continuous quality improvement program, significantly reducing medication errors.
- Conducted regular audits of controlled substances inventory to maintain accurate records and prevent diversion.
- Provided counseling to patients regarding medication usage and potential side effects.
Director, Quality Systems - Latin America, Asia Pacific and Emerging Markets Quality Operations
Merck Manufacturing Division
04.2010 - 12.2012
- Broad global experience in directing and assuring ongoing development for critical Quality Management Systems in Latin America, Asia Pacific, and Emerging Markets, including the implementation of sound and compliant harmonized Quality Systems and establishment of the regional implementation strategy in support of both commercial and clinical products
- Provided guidance and support to sites on quality system implementation and tracking as well as variance approval
- Projects included: Regulatory Intelligence Team representative for Latin America/Asia Pacific regions and PAI Readiness subdean, Implementation of Lean Labs at Merck Singapore location, Quality lead for Merck QbD Realization Team and QbD Quality- Regulatory subdean, Coordinating certification of global Merck/ external sites by Russia, Tracking/reporting of significant quality issues for Latin America and Asia Pacific
Director, Regulatory Compliance and Quality Systems, PSQ
Schering-Plough Research Institute
07.2008 - 04.2010
- Responsible for directing all activities associated with four distinct Quality Systems that are critical to maintaining the Pharmacy cGMP clinical supply chain: Change Management System, Investigations/Deviations/CAPA System, Clinical Customer Complaints System, Product Specification File System
- Single Process Owner for all four systems, with overall accountability for the effectiveness and efficiency of these systems and processes
- Single Business Owner for Pharmacy Quality Tracking System (validated GMP tracking system based on TrackWise platform) and business approver on all associated Computer System Validation documentation
- Owner for global process and procedures
- Managed, prioritized, and deployed continuous improvement projects across systems, processes, and sites
- Co-managed, developed, and delivered global training with some local site participation
- Responsible for managing e-access and approval of system roles
- Centralized management and reporting of global system metrics across sites
- Responsible for integration of Pharmacy quality systems globally among Pharmacy sites and linkages to commercial and clinical operations
Manager, Regulatory Compliance, PSQ
Schering-Plough Research Institute
08.2005 - 07.2008
- Responsible for the Change Management function of Pharmaceutical Sciences Quality
- Responsible for providing strategic and operational decision making related to Change Management Quality System and its practices to all areas in Pharmaceutical Sciences worldwide
- Ensured that the CM system is in compliance with external FDA/EU GMPs and applicable internal worldwide policies, standards and Standard Operating Procedures
- On a continuous basis, monitors the overall performance of the CM System for operational efficiency and effectiveness
- Presented metrics and any recommended actions to relevant Senior Management Compliance Forums
- Co-lead of Pharmaceutical Sciences Change Management Reengineering Team
- Successfully led the quality and regulatory intelligence process within the Regulatory Compliance of Pharmaceutical Sciences (Pharmacy) Quality to ensure the timely assessment, interpretation and implementation of new and revised regulatory/compliance requirements
- Represented PSQ on cross-functional regulatory assessment team charged with executing regulatory assessment activities and developing of implementation strategies cross-functionally with technical areas in Pharmacy and Global Regulatory Affairs
Manager, Regulatory Documentation Compliance, NJ Quality Operations
Schering-Plough Corporation
11.2002 - 08.2005
- Responsible for the direction and decision making for Global Change Management systems and practices
- Initiates, plans, and executes activities to support objectives of Technical and Quality Operations while maintaining compliance with regulatory agencies
- Ensured change management systems and practices remained compliant with current regulatory requirements
- Directed the site change management processes and activities
- Provided metrics, tracked and trended change management
- Directed creation of a single document and process for initiation of changes within NJ Technical and Quality Operations, including creation/revision of associated SOPs and management of legacy changes to closure
Manager, Quality Assurance
The P.F. Laboratories, Inc.
08.2001 - 11.2002
- Assessed CGMP compliance profile for manufacturing, packaging, testing, and warehousing operations at P.F Laboratories Inc.
- Directed internal audit program, training and deploying three auditors while managing compliance audit schedule.
- Tracked and analyzed CAPA items from audit observations, investigations, and customer complaints.
- Reviewed customer complaints and initiated action plans as necessary.
- Collaborated with departments to create effective CAPAs based on internal audit findings.
- Evaluated and approved Validation Protocols, Master Batch Records, Annual Product Reports, and Standard Operating Procedures.
- Reviewed all investigations of products for US market from Totowa facility, ensuring regulatory compliance.
Senior Quality Assurance Specialist
The P.F. Laboratories, Inc.
01.2000 - 08.2001
- Responsible for daily quality assurance activities and GMP compliance relating to the manufacturing, packaging, and distribution of drug products at The P.F Laboratories, Inc
- Reviewed and approved deviations to standard operating procedures, master formulas, quality standards and test methods
- Reviewed and approved production investigations
- Responsible for the approval/rejection of raw materials, packaging materials and labeling materials for production; and the approval/rejection of finished drug product for commercial distribution
- Responsible for developing and maintaining a training program for P.F Labs employees
- Responsible for reviewing documents for compliance to cGMP, NDA commitments and FDA requirements
Quality Assurance Supervisor
P.F. Laboratories, Inc.
07.1999 - 01.2000
- Reviewed and approved drug product batch production records for compliance with CGMP standards.
- Supervised quality assurance processes to uphold industry standards.
- Conducted regular audits of laboratory operations, identifying areas for improvement.
- Developed and implemented quality assurance policies to strengthen product integrity.
- Coordinated training programs for staff on quality control procedures and best practices.
- Led cross-functional teams to resolve quality issues and promote continuous improvement.
- Analyzed test results and prepared reports for management review and decision-making.
- Performed root cause analysis investigations into non-conforming products or processes.
Technical Advisor, Manufacturing, Packaging and Labeling Operations
The P.F. Laboratories, Inc.
06.1998 - 07.1999
- Supervised 15 to 20 packaging personnel, focusing on training and development initiatives.
- Authored and reviewed SOPs for technological updates and procedural changes.
- Managed packaging requirements during validation protocols, including IQ, OQ, and PQ.
- Contributed to change control processes and ensured regulatory compliance.
- Oversaw updates in pharmaceutical packaging technology to enhance operational efficiency.
Staff Pharmacist
VA Medical Center
01.1995 - 01.1997
- Collected and reported adverse events from health care professionals.
- Conducted drug utilization reviews for managed care clinics to ensure compliance.
- Monitored drug safety in various studies through surveillance of literature and databases.
- Managed narcotic distribution, inventory, cycle counts, and adherence to DEA regulations.
- Provided accurate drug information to health care professionals and patients.
- Trained in Chemotherapy, IV Antibiotics, and TPN preparations to support clinical needs.
Education
MBA - Pharmaceutical-Chemical Studies
Fairleigh Dickinson University
Florham Park, NJBachelor of Science - Pharmacy
LIU College of Pharmacy
Brooklyn, NYSkills
- Leadership and team development
- Time management
- Medication and prescription management
- Immunization administration
- Regulatory compliance
- Project coordination
- Risk assessment and mitigation
- Quality improvement initiatives
- Licensed pharmacist, NJ
Certification
Six Sigma Certification
PMP Certification
Licensed Immunization Pharmacist
Accomplishments
- Collaborated with team of 10-15 professionals in the development of a Clinical Rx Trackwise System with a linkage to Commercial Development that improved efficiency in areas of compliance, manufacturing, distribution of drug product. The system was efficient and easily used by scientist in clinical as well as technical operations and post marketing surveillance.
- Achieved 80% efficiency through effectively linking clinical and commercial systems.
- The net result was a cost savings to the business of greater than 80% and a cost benefit globally greater than 90% as the system was launched globally.
- My team trained and launched a successful Tx system in Singapore, Ireland, Denmark, China, Japan , Puerto Rico, United States and many global sites eg France, for a successful global launch.
Affiliations
- Certified as a New Jersey Quality Control Professional
- Rahway Organization Site lead
- Co-chair of HiSPanos (S-P Hispanic Colleague Network)
- Member of American Society of Health System Pharmacists
- Member of the National Society of Hispanic MBAs
- Member of the Drug Information Association
- Member of the Parenteral Drug Association
Languages
Spanish
Professional
References
References available upon request.
Timeline
Pharmacist
Walgreens Boots Alliance
03.2025 - 06.2025
Pharmaceutical Immunization/Medical Consultant
Pharmaceutical
05.2015 - Current
Director, Global Science Technology and Commercialization: Comm. & Supply Analytical
Merck Manufacturing Division
01.2013 - 05.2015
Director, Quality Systems - Latin America, Asia Pacific and Emerging Markets Quality Operations
Merck Manufacturing Division
04.2010 - 12.2012
Director, Regulatory Compliance and Quality Systems, PSQ
Schering-Plough Research Institute
07.2008 - 04.2010
Manager, Regulatory Compliance, PSQ
Schering-Plough Research Institute
08.2005 - 07.2008
Manager, Regulatory Documentation Compliance, NJ Quality Operations
Schering-Plough Corporation
11.2002 - 08.2005
Manager, Quality Assurance
The P.F. Laboratories, Inc.
08.2001 - 11.2002
Senior Quality Assurance Specialist
The P.F. Laboratories, Inc.
01.2000 - 08.2001
Quality Assurance Supervisor
P.F. Laboratories, Inc.
07.1999 - 01.2000
Technical Advisor, Manufacturing, Packaging and Labeling Operations
The P.F. Laboratories, Inc.
06.1998 - 07.1999
Pharmacist
Goodrich Pharmacy
06.1996 - 01.2013
Staff Pharmacist
VA Medical Center
01.1995 - 01.1997
MBA - Pharmaceutical-Chemical Studies
Fairleigh Dickinson University
Bachelor of Science - Pharmacy
LIU College of Pharmacy
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