LEAH J. TUFTS
Boca Raton,FL
Summary
Results-driven leader with solid record of success in driving operational excellence, expanding organizational capacity, and maintaining impeccable quality in a highly regulated industry. Big picture thinker; consistently deliver strong results by connecting the vision, strategy, and operating plan. Agile in adapting to rapidly changing business needs; thrive on new challenges. Catalyst for change; willing to challenge the status quo to transform an underperforming business or take a growing one to the next level. Experienced in managing projects from conception through completion. Led cross-functional teams and collaborative projects involving multiple internal and external business teams. Reputation for integrity, sound business judgment, and commitment to quality.
Overview
17
17
years of professional experience
Work History
Vice President, Global Clinical Trial Distribution (CTD) Harmonization
MARKEN – A UPS Company
Durham, USA
04.2023 - 03.2024
- Company Overview: Provider of global storage and distribution of clinical trial materials
- Work in conjunction with the Regional Leads and Directors of the CTD GMP network to improve procedures for increased compliance and efficiency, train global staff to ensure the operations performed meet client, business, and quality requirements, own, report and analyze business line profit and loss statement, establish KPIs and objectives to enable data driven business decisions, and identify and resolve systemic barriers to improve process and culture
- Oversaw 14 global depots including 5 Directors, 50 Project Managers, and 75 Operations staff members
- Managed team responsible for aligning goals and operational requirements globally to improve efficiency and customer experience
- Supported Business Development in completing RFIs and bid defenses as the SME
- Reduced order pick and pack time by 25% and required study start up documentation by 75%
- Improved deviation on-time-completion by 72%
- Discovered and resolved inaccurate cost and revenue allocation on business line P&L
- Reduced CTD costs by 60% for shared sites and created headcount planning tool to maximize resources and reduce overtime
- Provider of global storage and distribution of clinical trial materials
Regional Director, North America, Clinical Trial Distribution
MARKEN – A UPS Company
Durham, USA
05.2021 - 04.2023
- Company Overview: Provider of global storage and distribution of clinical trial materials
- Directed North American operations – Responsible for the implementation, maintenance, and follow up of the operations performed in the GMP Depots in the North American region owned by Marken
- Ensured the operational procedures were developed to comply with GMP, Marken, and regulatory standards, while meeting company standards to ensure systems, resources, and capacity were sufficient to meet business requirements
- Successfully managed the transfer of current investigational medicinal product (IMP) stock from one depot to another under agreed upon client procedures and transfer plan with no deviations or temperature excursions
- Oversaw the acquisition, site upgrades, installation and qualification of new systems and equipment to introduce expanded capabilities and footprint to Marken’s NORAM CTD network
- Hired 30+ team members to staff the three new locations within 18 months
- Successfully co-hosted 2-week UPS corporate audit with no critical findings
- Managed the implementation and site 'go-live' for Marken’s Burlington, Ontario site, including assessment of regional differences in regulatory compliance, on-boarding of support vendors, and hiring of staff within a 12-week period
- Provider of global storage and distribution of clinical trial materials
Vice President/General Manager, US Operations
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
West Chester, USA
06.2018 - 03.2021
- Company Overview: Provider of secondary packaging, labeling and global distribution of materials for clinical studies
- Directed US operations – P&L management, procurement, manufacturing, quality assurance, logistics, project management
- Communicated clear vision and expectations to foster engagement and alignment among diverse stakeholders
- Provided clinical trial expertise to inform business decisions by the Board and C-suite leaders regarding expansion, cost control, QA and compliance
- Led process improvement initiatives to drive efficiencies while maintaining stringent quality standards
- Provided leadership for 11 managers, 2 specialists, and 18 indirect reports
- Directed process optimization and capacity building initiatives that facilitated unprecedented growth
- Added $410K in storage space and equipment; on track to achieve ROI by October 2020 – 22 months ahead of projections
- Grew the business every year during tenure: Logistics ↑454% – Packaging ↑818%, 2013-2019
- Delivered significant revenue growth in 2019: Packaging ↑40% – Logistics ↑30%
- Built world-class teams with high productivity, low absenteeism/turnover
- Established a culture of accountability and commitment to quality resulting in outstanding performance
- Saved $380K per year by replacing single-use shippers with a scalable, sustainable/reusable product
- Reduced waste by ~1M tons in 3 years
- New shippers have a 5-year useful life and achieve ROI within 3 uses
- Projected return to bottom line: $20,475 per shipper
- Reduced costs ~$65K-$70K annually by creating procedures to perform installation, operational and performance qualification tasks in-house ($50K) and establishing mapping protocol temperature-controlled storage conditions ($15K-$20K)
- Oversaw clinical services operations at Berlin site while concurrently managing US operations
- Provider of secondary packaging, labeling and global distribution of materials for clinical studies
Senior Manager, Quality & US Operations
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
West Chester, USA
08.2017 - 06.2018
- Company Overview: Provider of secondary packaging, labeling and global distribution of materials for clinical studies
- Managed GMP-compliant facility in addition to QA
- Developed strategies and executed action plans to ensure packaging and logistics supported the needs of the business and aligned with corporate goals
- Continued to infuse quality consciousness throughout the operation
- Created and delivered annual GMP training, including Good Documentation Practices (GDP); led DEA and Health Canada controlled substance training programs for sales, operations, and QA teams
- Established Bellwyck’s presence in the EU for clinical packaging and distribution
- Entered joint venture, oversaw planning and site build-out in Germany
- Developed policies and procedures, hired and trained staff
- Hosted successful LAVG audit and secured licensing
- Delivered average 20% EBITDA the first year (2019)
- Aligned processes and procedures between the company’s 2 North American sites to improve consistency of the customer experience
- Assessed best practices and rolled out standardized global procedures to both sites
- Provider of secondary packaging, labeling and global distribution of materials for clinical studies
Senior Manager, Quality Assurance
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
West Chester, USA
08.2015 - 08.2017
- Company Overview: Provider of secondary packaging, labeling and global distribution of materials for clinical studies
- Managed customer audits, vendor audits and implemented follow-up actions to ensure compliance with quality and regulatory requirements
- Established quality awareness at every step of the process
- Provided leadership for QA Manager plus 9 QA Associates and Inspectors
- Reported to Vice President, Clinical Services
- Key contributor on team that created the templates, scoring scale and instructions to standardize the company’s performance review process
- Guided Executive Leadership Team in setting annual goals for improving quality and other KPI metrics
- Implemented First Time Right (FTR) KPI metrics to indicate procedural or personnel issues prior to Quality performance impact
- Provider of secondary packaging, labeling and global distribution of materials for clinical studies
Quality Assurance Manager, US
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
West Chester, USA
03.2013 - 08.2015
- Company Overview: Provider of secondary packaging, labeling and global distribution of materials for clinical studies
- Managed QA activities, including audits, documentation, and quality data management
- Partnered with other departments to resolve quality issues
- Identified training opportunities; worked with department heads and HR to ensure proper training for all employees
- Established the company’s physical presence in the US following Bellwyck’s acquisition of Patheon Clinical
- Planned and developed the West Chester site – drafted floorplan – temperature-controlled packaging rooms, storage areas, and a DEA-licensed controlled substance vault
- Developed full Quality System
- Oversaw physical move and data migration
- Built QA infrastructure, obtained licenses and client approval for a new GMP facility
- Managed transfer of operations from old to new site, while maintaining compliance at both sites during transition
- Developed and revised SOPs and protocols to improve compliance and increase efficiency
- Provider of secondary packaging, labeling and global distribution of materials for clinical studies
Researcher & Senior Researcher
THE PROCTER & GAMBLE COMPANY
Cincinnati, USA
09.2011 - 03.2013
- Designed ground-breaking product prototypes to address market opportunities
- Led change and expanded P&Gs’ capabilities for understanding how the production process affects the manufactured product by developing new test methods that modeled physical product attributes
- Earned promotion to Sr
- Researcher well ahead of peers due to technical mastery and demonstrated leadership
- Collaborated with SMEs to leverage existing knowledge and testing methods for use across all business areas
- Redesigned existing methods to fit specific project needs
- Validated methods for use as release criteria in manufacturing plants
- Developed FDA-compliant SOPs for newly developed methods
- Trained plant personnel on inline testing of new methodologies
Quality Assurance Inspector I & II
FOREST PHARMACEUTICALS
Cincinnati, USA
08.2007 - 09.2011
- Performed in-process checks and audits on manufacturing and packaging operations
- Investigated customer complaints; worked with leadership to resolve issues and prevent recurrence
- Wrote deviation reports
- Conducted quarterly internal audits across all departments; implemented Corrective and Preventive Action (CAPA) procedures to ensure cGMP compliance
- Served as QA Representative on new product launch teams
- Vastly improved the QA Cleaning Validation program as its sole QA reviewer
- Implemented new procedures that reduced downtime on the production line and required fewer QA resources for cleaning validation
- Named Acting QA Supervisor during a colleague’s 6-month medical leave
- Took on additional responsibilities – escorted FDA auditors through on-floor inspections, implemented resolutions to customer complaint investigations and deviation reports
Education
Master of Business Administration -
UNIVERSITY OF CINCINNATI
Cincinnati, OHMaster of Science - Pharmaceutical Sciences/ Drug Development
UNIVERSITY OF CINCINNATI
Cincinnati, OHBachelor of Science - Nutrition
UNIVERSITY OF KENTUCKY
Lexington, KYSkills
- Change Management
- Regulatory Compliance
- Leadership
- Business Planning and Management
- Strategic Planning & Execution
- Quality System Development
- Budget Management
- Cross-functional Communication
- Team Building & Mentoring
- Process Optimization
- Operations Infrastructure Development
- Capacity Planning and Enhancement
- Performance Analysis
- Inventory Management
- Business Performance Improvement
- Training Development
Timeline
Vice President, Global Clinical Trial Distribution (CTD) Harmonization
MARKEN – A UPS Company
04.2023 - 03.2024
Regional Director, North America, Clinical Trial Distribution
MARKEN – A UPS Company
05.2021 - 04.2023
Vice President/General Manager, US Operations
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
06.2018 - 03.2021
Senior Manager, Quality & US Operations
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
08.2017 - 06.2018
Senior Manager, Quality Assurance
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
08.2015 - 08.2017
Quality Assurance Manager, US
BELLWYCK PHARMA SERVICES (now PCI Pharma Services)
03.2013 - 08.2015
Researcher & Senior Researcher
THE PROCTER & GAMBLE COMPANY
09.2011 - 03.2013
Quality Assurance Inspector I & II
FOREST PHARMACEUTICALS
08.2007 - 09.2011
Master of Business Administration -
UNIVERSITY OF CINCINNATI
Master of Science - Pharmaceutical Sciences/ Drug Development
UNIVERSITY OF CINCINNATI
Bachelor of Science - Nutrition
UNIVERSITY OF KENTUCKY
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