Doug Lenna, Mba Email & Phone Number

Privately own Consulting firm helping improve and develop quality systems for pharmaceutical, health/beauty, and consumer goods.

Developing and implementing quality assurance and quality control processes and procedures.Conducting research and analysis to identify the strengths and weaknesses of current quality practices.Reviewing policies and regulations to ensure compliance and alignment with industry best practicesCoordinating with other staff to gather and analyze data.

Boca Raton, Florida, US

Providing quality and operational systems supportWriting Annual Product Review (APR)Providing consulting services for investigationsProviding input for effective CAPAaProviding support for system and facility upgrades and enhancementsNew Equipment selection, IQ/OQ/PQ

• Took charge of converting the facility from a CBD Research and Development facility to full Commercialization CBD facility.Directly performed gap analysis of compliance and operational aspects of the facility; written.
• Lead the operations and management of conversion to a large-scale ethanol extraction and manufacturing facility
• Design and implement business strategies, plans and procedures
• Set comprehensive goals for performance and growth
• Establish policies that promote company culture and vision
• Oversee daily operations of the company during transition period

Irvine, CA, US

• Direct all aspects of 50,000sq ft facility and 40,000sq ft secondary warehouse sites including maintenance, quality, and operations
• Direct the manufacturing, packaging, and distribution of both proprietary and CMO pipeline, including development of new ANDA and R&D activities for manufacturing and packaging totaling 44 products with multiple skews.
• Manage site P&L, operational budget, including inventory, direct labor, overhead, operations, and quality
• Implement a continuous improvement environment focusing on a “right-first-time” approach and reduction of redundancies
• Decrease operational COGs 15% year over year through efficient management of quality, cost control methods and improved utilization of resources
• Determine site staffing requirements; directly involved with the interviewing and hiring process for site personnel

Hyderabad, TS, IN

• Direct responsibility for defining business processes and solutions for implementation of quality improvements and best practices for GMP compliance resulting in the reduction of quality and personnel related issues by.
• Decrease in operation incident rate and achieved 95% RFT, reduction of quality and personnel related issues by 70% within 18 month period, achieved and sustained 0% overdue incident and CAPA levels. Increased outputs.
• Direct all aspects of Manufacturing and Packaging operation of 180 employees contributing to the growth in generic sales
• Direct onsite, global, and external customer interaction with accountability for manufacturing, packaging, quality, and compliance
• Continuous interaction with corporate and site validation, engineering, and maintenance groups for site upgrades, improvements, expansions, new equipment, and site transfer activities
• Knowledge and direct involvement with United States – FDA and internal and external audit groups.

Tel-Aviv, IL

• Performed US and Global site audits for cGMP and compliance readiness and conducted remediation programs
• Knowledge and direct involvement with United States - FDA, Canadian – HPB/Health Canada, and European - EMA agency requirements
• Collaboration and interaction with manufacturing, quality, and compliance groups for all Teva, Pliva, and Barr facilities in United States, Poland, Croatia, and Canada
• Responsible for Quality investigation, compliance, and FDA responses; developed and monitored CAPA administration, compliance and remediation teams
• Direct project responsibility for defining business processes and solutions for selection and implementation of Oracle based ERP system for multiple US based facilities
• Developed and managed continuous improvement projects for manufacturing and quality operations for US and International divisions

Owner/President Licensed, certified, master designer and installer of commercial, residential irrigation system, electrical, plumbing, and water conservation systemsCreated and Incorporated irrigation and night lighting business into northeast competitive businessDesigned, estimated, marketed, and serviced the installations of irrigation and night/accent.

Chestnut Ridge, NY, US

• Engineering / Maintenance System Development
• Performed capital equipment selection and installation/operational qualifications
• Established and maintained preventive maintenance tracking system for three interstate manufacturing facilities
• Directed and trained maintenance personnel in proper procedures to perform facility and equipment preventive maintenance and calibration functions
• Conducted facility safety and cGMP audits and employee training sessions

• Various positions of increasing responsibility, from operator, supervisor, to final role as Pharmaceutical Engineering Validation Coordinator.
• Assisted in establishing and maintaining divisional personal computer network including computer hardware and software selection, installation and system maintenance
• Developed early stage computer assisted pharmaceutical process system
• Performed retrospective and concurrent product testing and statistical data analysis to compile Validation Protocols for non-sterile finished products
• Investigated manufacturing procedures, processes, equipment, raw material, and in-process controls to ensure compliance with GMP and FDA regulations
• Directed and supervised 28-44 employees including 3 supervisors, scheduled complete equipment maintenance, over-haul, set-up operations for entire production operations

Master Of Business Administration - Mba

Six Sigma

Bachelor Of Science, Business Management