TODD W. PERSON
Miramar
Summary
With over 31 years of experience in the pharmaceuticals and medical device & combination products industry, my expertise spans across various areas. These include quality management systems (QMS) and regulatory compliance, supplier management and purchasing controls, package engineering and project management, as well as product launches. I am well-versed in lean sigma methodologies such as TPS, KATA, Hoshin Kanri, and Teir Management. Additionally, I have a strong background in CAPA, complaint, deviation/non-conformity, and CAPA management, as well as notified body (NOB) and health authority reporting. My knowledge extends to ISO 13485:2016, ISO 14971:2019, EU MDR 2017/745, 21CFR 820 and Part 4, as well as 21CFR 210 and 211. Furthermore, I possess expertise in MDSAP.
Overview
32
32
years of professional experience
Work History
Director of Quality, MDCP (Medical Device Combination Product)
Organon
01.2021 - Current
- Lead global MDCP compliance initiatives, managing a team of 7 design engineers
- Oversee Design Controls, Device Risk Management, and Post Market Surveillance across Medical Devices & Combination Products
- Lead external audits for ISO 13485, MDSAP, and EU MDR certifications & internal audits for 21CFR 820 & Part 4
- Management Representative with Executive Responsibility for Combination Products and Medical Devices
- Person Responsible for Regulatory Compliance (PRRC) for the JADA SYSTEM Medical Device
Director of Quality, MDCP
Merck Sharp & Dohme
Remote
01.2017 - 01.2021
- Directed global MDCP managing 9 device engineers in Design & Development activities for new MDCPs products as well as Post Market Surveillance and Vigilance for MDCPs currently on the market
- Assisted in the creation of a new MDCP Quality Department totaling 20
- Assisted in the integration of 21CFR 820 Part 4 requirements in Merck’s Quality Systems: CAPA, Design Controls, Device Risk Management, and Purchasing Controls
- Managed a team of 5 consultants to create retrospective Design History and Device Risk Management Files to comply with 21CFR 820 Part 4
- Led regulatory and post-market activities, driving continuous improvement
- Management Representative with Executive Responsibility for Combination Products
Director of Quality
Merck Sharp & Dohme
Miami Lakes, USA
01.2015 - 01.2017
- Led site quality operations for two product lines across domestic and international markets
- Managed a $4.2M budget and ensured regulatory compliance for product quality and manufacturing systems
- Managed a staff of 30 involving: Stability, Micro, Analytical Release, Batch Release, Regulatory Compliance, Audits, Computer & Software Validations and Customer Complaints
Associate Director of Quality Systems and Regulatory Compliance
Merck Sharp & Dohme
Miami Lakes, USA
01.2013 - 01.2015
- Led 9-person team managing change controls, complaints, and regulatory compliance activities
- Ensured site compliance with global standards, including audits and recall management
Associate Director, Quality Operations
Merck Sharp & Dohme
Miami Lakes, USA
01.2011 - 01.2013
- Managed quality operations for raw materials and packaging component releases
- Led batch record review and release processes for regulatory compliance
Associate Director, Merck Production Lead
Merck Sharp & Dohme
Miami Lakes, USA
01.2010 - 01.2011
- Utilizing the Toyota Production System methodology, installed a culture of continuous improvements by
- Training shopfloor employees to gain certification in Green & Yellow Belt Certifications
- Implementation of Hoshin Kanri, Gamb Walks, Tier Management, KATA, and Kaizens
- Training shopfloor and key SMEs on the principals of Scientific Problem Solving to reduce Non-Conformities and Deviations
MiraLAX Project Manager
Merck Sharp & Dohme
Miami Lakes, USA
01.2009 - 01.2010
- Managed project from equipment procurement, facility redesign to regulatory filing, overseeing $8MM in capital spend
Interim Production and Engineering Manager
Schering Laboratories
Miami Lakes, USA
01.2008 - 01.2009
- Managed site production activities and engineering capital projects during leadership vacancies
Right the First Time Manager
Schering Laboratories
Miami Lakes, USA
01.2007 - 01.2008
- Manage the implementation, rollout, and sustained success of the Right the First Time Program at the Miami Lakes site as an enabler to reduce costs, inventory and cycle times while building a culture through leadership behaviors
- RFT Program – A continuous improvement process involving six sigma, lean manufacturing techniques and Schering Plough methodology
Quality System Program (QSP) – Engineering Team Leader
Schering Laboratories
Miami Lakes, USA
01.2003 - 01.2007
- Led the Familiarization process, Gap Analysis development, and implementation of Corrective Action Plans within the Quality Systems Department
- Familiarization: Coordinated SME selection and training on Corporate Quality Standards
- Gap Analysis: Led team to assess site procedures for cGMP compliance, generating reports for senior management
- Action Plans: Worked with senior management to outline and present Corrective Action Plans to ensure compliance with Corporate Quality Standards
- Corporate Quality Standards: Managed and implemented site-level standards including Validation (Planning/Packaging Systems/Cleaning & Drug Product), Calibration Program, Environmental Monitoring, Facility Cleaning & Sanitization, HVAC Controlled Environments, Control of Printed Materials, Mgmt
- Of GMP Projects, Maintenance Program, Water & Clean Steam, Drug Product Facility Design and more
- Documentation: Developed new SOPs for equipment classification and revised existing SOPs for alarm reporting and investigations
- Project Management: Co-developed an internal resource tracking tool to manage departmental resources, track action items, and forecast needs
- Compliance: Provided guidance on validation documents for compliance with cGMPs and Corporate Standards
Senior Package Engineer
Elan Pharmaceuticals
Miramar, USA
01.2000 - 01.2003
- Led package development and validation, supporting global product launches and regulatory submissions to include:
- Package Development / Graphic Design / Validation /Product/Package Transfers / Process Improvements involving redesign of packages & qualification of alternative materials / Investigations at CMO’s
Senior Package Engineer
Applied Analytical Industries (AAI)
Wilmington, USA
01.1998 - 01.2000
- Managed packaging engineering projects, including process validation and new product launches to include
- Project Management / Clinical Packaging /Package Engineering Services to Clients / Validations for ANDA in manufacturing and packaging
Professional Hockey Player
RALEIGH ICE CAPS
NC, USA
01.1998 - 01.2000
- Involved in Public Relations, including public appearances, hospital visits, radio talk shows, club promotions and community service
- Developed strong team concepts as well as interpersonal and leadership skills
Production Supervisor II
Applied Analytical Industries (AAI)
Wilmington, USA
01.1996 - 01.1998
- Managed a staff of twelve production technicians to provide technical leadership for projects involving the manufacturing and packaging of clinical supplies, research & development batches for submission and commercial supply
- Project Planning – Coordinated the daily and weekly scheduling for multiple shifts for the manufacturing and packaging of clinical supplies, research & development batches, commercial supplies, and all equipment to be protocol cleaned and released from Analytical Services
- Validations – Coordinated and trained production personnel on validation protocols for manufacturing and packaging to pull document and perform in process tests in support of process enhancements and new product launches
- Documentation – Assisted in the generation, review and approval of packaging and manufacturing batch records, scale up batch records, validation protocols and NDA/ANDA submissions
- Investigations/Deviations – Responsible for the completion of root cause analysis, recommendations and implementation of corrective measures surrounding manufacturing and packaging process related issues for batches involving clinical supply, pilot and pivotal batches for submissions and routine commercial batches for distribution
- Compliance – Monitored the daily floor activities to ensure technicians were in compliance with cGMP’s and company approved SOP’s
Production Supervisor II
Janssen Pharmaceutica
Titusville, USA
01.1995 - 01.1996
- Designed, developed, implemented, and maintained packaging engineering activities to meet Production and Marketing Customer requirements in support of product demands for on time new product launches, line extensions and prevention of back orders
- New Product Launches /Process Improvements & Cost Savings / Graphic Design / Project Management
Package Engineer
Glaxo Inc.
Zebulon, USA
01.1993 - 01.1995
- Develop specifications and Bill of Materials for new and existing packaging components for solid oral dosages and non-sterile liquids while managing continuous process improve projects and new product launches
- New Product Launches and Line Extensions – Coordinated the packaging activities to successfully launch Flonase Nasal Spray, Zantac 180 count line extension and Zantac sample package
- Process Improvements/Cost Savings – Continued pack simplification projects to reduce or eliminate package material by 10% by removing trays and shrink-wrap and downsizing and consolidating cases to Regular Slotted Containers (RSC) from Center Slotted Special Container (CSSC)
Education
Bachelor of Science - Package Engineering
Rochester Institute of Technology
Rochester, NY01.1993
Skills
- Skilled in MS Project, Excel, and Word
- Proficient in Presentation Software
- International Quality Assurance
- ETQ Change Management Expertise
- Workday Application Expertise
Timeline
Director of Quality, MDCP (Medical Device Combination Product)
Organon
01.2021 - Current
Director of Quality, MDCP
Merck Sharp & Dohme
01.2017 - 01.2021
Director of Quality
Merck Sharp & Dohme
01.2015 - 01.2017
Associate Director of Quality Systems and Regulatory Compliance
Merck Sharp & Dohme
01.2013 - 01.2015
Associate Director, Quality Operations
Merck Sharp & Dohme
01.2011 - 01.2013
Associate Director, Merck Production Lead
Merck Sharp & Dohme
01.2010 - 01.2011
MiraLAX Project Manager
Merck Sharp & Dohme
01.2009 - 01.2010
Interim Production and Engineering Manager
Schering Laboratories
01.2008 - 01.2009
Right the First Time Manager
Schering Laboratories
01.2007 - 01.2008
Quality System Program (QSP) – Engineering Team Leader
Schering Laboratories
01.2003 - 01.2007
Senior Package Engineer
Elan Pharmaceuticals
01.2000 - 01.2003
Senior Package Engineer
Applied Analytical Industries (AAI)
01.1998 - 01.2000
Professional Hockey Player
RALEIGH ICE CAPS
01.1998 - 01.2000
Production Supervisor II
Applied Analytical Industries (AAI)
01.1996 - 01.1998
Production Supervisor II
Janssen Pharmaceutica
01.1995 - 01.1996
Package Engineer
Glaxo Inc.
01.1993 - 01.1995
Bachelor of Science - Package Engineering
Rochester Institute of Technology
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