Lori Anne Stoepel
Randolph,NJ
Summary
Pharmaceutical professional with a comprehensive background in medication management, patient care, and regulatory compliance. Enhances therapeutic outcomes through collaboration and adaptation to evolving healthcare needs. Demonstrates strong expertise in pharmacology, prescription accuracy, and patient counseling. A reliable team player with a results-driven approach and excellent communication skills. Brings over 15 years of pharmaceutical experience with strategic and operational successes in quality management, quality assurance, regulatory, technical, and quality operation functions. Known for strong collaboration skills and adaptability in dynamic environments. Analytical thinking and project management skills consistently lead to successful outcomes.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Pharmaceutical Consultant
Pharmaceutical Consultant
05.2015 - Current
- 🧪 Pharmaceutical Expertise
With over 15+ years of leadership in the pharmaceutical industry, including a focus on implementation of Global Quality Systems and Risk-Analysis, I bring a unique combination of skills and insights based on my background in pharmaceutical manufacturing, compliance and quality systems.
🔹Strategic Insights: Bridging scientific innovation with patient-centered solutions for impactful outcomes.
🔹Clinical Trial Expertise: Demonstrated success in managing therapeutic areas and driving operational excellence.
🔹Consulting Services: Supporting companies in optimizing Pharma strategies and enhancing scientific communication in core areas of regulatory and quality management/assurance and Quality Systems. - Key clients were both domestic and international with business operations in areas of innovative biopharmaceutical development and supply as well as generic pharmaceutical companies
Director, Global Science Technology and Commercialization: Comm. & Supply Analytical
Merck Manufacturing Division
01.2013 - 05.2015
- Directed and assured on-going integration of analytical and quality systems in Commercialization and Supply Analytical organizations in Ballydine, Ireland; Las Piedras and Arecibo, Puerto Rico
- Partnered with Regulatory CMC and Quality on new product introductions to coordinate site inspection readiness
- Conducted review of global submissions and provided guidance in responding to worldwide Health Authority requests or inspection related regulatory observations
- Provided regulatory assessment of proposed CMC changes impacting in-line APIs and drug products
- Responsible for the sound and compliant implementation of integrated and harmonized analytical and quality systems to support analytical development and supply testing operations including establishing the regional implementation strategy
- Provided global coordination and support for implementation of state of the art Lean Six Sigma laboratory operations across the Commercialization and Supply Analytical laboratories
- Supported establishment of appropriate Project Management structures to assure that initiatives meet established timeframes, and that progress was appropriately monitored
Pharmacist (Part-time)
Goodrich Pharmacy
06.1996 - 01.2013
- Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
- Developed strong relationships with healthcare providers to optimize patient care and medication adherence.
- Educated patients about possible drug interactions and gave special administration instructions.
- Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
- Reduced medication errors within the pharmacy by developing and implementing a continuous quality improvement program.
- Conducted regular audits of the pharmacy''s controlled substances inventory, ensuring accurate record-keeping and preventing diversion or theft.
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 subteam, Implementation of Lean Labs at Merck Singapore location, Quality lead for Merck QbD Realization Team and QbD Quality- Regulatory subteam, 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 PharmSci 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 PharmSci 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 PharmSci quality systems globally among PharmSci 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 (PharmSci) 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 PharmSci 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
- Responsible for assessing the CGMP compliance profile of the manufacturing, packaging, testing and warehousing operations of The P.F
- Laboratories Inc
- Through a system of periodic audit, compliance risk assessment and risk abatement
- Directed the internal audit program including the training, development and deployment of three internal auditors and the compliance audit schedule
- Responsible for tracking and trending CAPA items that resulted from audit observations, investigations, and customer complaints
- Reviewed and assessed customer complaints and developed action plans if required
- Interfaced with appropriate departments to develop effective CAPAs based on internal audit observations
- Reviewed and approved Validation Protocols and reports, Master Batch Records, Annual Product Reports and Standard Operating Procedures
- Responsible for the review and approval of all investigations of products intended for the US market of products manufactured in the Totowa facility
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
- And its contractors
- 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 approve drug product batch production and control records for compliance to CGMP and suitability for commercial distribution
- Reviewed raw material, packaging material and labeling material quality control test and inspection data for compliance to specifications and acceptability for use in the production of drug products
Technical Advisor, Manufacturing, Packaging and Labeling Operations
The P.F. Laboratories, Inc.
06.1998 - 07.1999
- Direct supervision of 15 to 20 packaging personnel, including all aspects of training and development
- Wrote and reviewed SOPs encompassing various technological/ mechanical updates as well as procedural changes
- Responsible for packaging requirements during various validation protocols (IQ, OQ, and PQ)
- Actively involved in change control and regulatory compliance
- Responsible for pharmaceutical packaging technology updates
Staff Pharmacist
VA Medical Center
01.1995 - 01.1997
- Responsible for the collection and reporting of adverse events from health care professionals
- Fully trained in Chemotherapy, IV Antibiotics and TPN Preparations
- Monitored drug safety in various drug studies through the surveillance of information sources-including published literature, selected databases, and the Internet
- Responsible for narcotic distribution and inventory as well as cycle counts and DEA regulations
- Conducted drug utilization reviews and evaluations for managed care clinics
- Provided drug information to health care professionals as well as patients
Education
Master of Business Administration - Pharmaceutical-Chemical Studies
Fairleigh Dickinson University
01.2003
Bachelor of Science - Pharmacy
Arnold and Marie Schwartz College of Pharmacy, Long Island University
01.1994
Skills
- Clear Verbal Communication
- Customer Service Expertise
- Talent Development
- Accurate Medication Distribution
- Prescription Accuracy Management
- Health Awareness Education
- Client-Centric Approach
- Pharmaceutical Dispensing Education
- Skilled in Time Allocation
Accomplishments
- Collaborated with team of 10-15 professionals in the development of a Clinical Tx 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.
Committees Societies Professional Affiliations
- Certified as a New Jersey Quality Control Professional
- Rahway Hispanos 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
Publications Presentations
Pharmaceutical Quality Systems, Swroop Sahota, Ph.D., ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10, 10/06/10, Washington, DC
Awards
- Pharmaceutical Sciences and Drug Metabolism Excellence Award - 2009
- Development Excellence - SPRI 2008
- Development Excellence - SPRI 2007
- New Jersey Minority Achiever - Summit Area YMCA 2007
- Supervisor of the Year - Stevens Institute of Technology 2004
Key Certifications Training Programs
- Merck Sigma Green Belt certified
- Management Excellence Program
- Situational Coaching
- Supply Improvement Process
- Validation Life Cycle and Change Control
- Drug Development Process
- Annual Pharmacy CE credits
Certification
- Six Sigma Certification
Languages
Spanish
Limited Working
Timeline
Pharmaceutical Consultant
Pharmaceutical Consultant
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 (Part-time)
Goodrich Pharmacy
06.1996 - 01.2013
Staff Pharmacist
VA Medical Center
01.1995 - 01.1997
Bachelor of Science - Pharmacy
Arnold and Marie Schwartz College of Pharmacy, Long Island University
Master of Business Administration - Pharmaceutical-Chemical Studies
Fairleigh Dickinson University
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