•Directly managed, lead, and supervised the Quality Department in a FDA regulated environment (21 CFR 111, 211, 700 and 820).•In charge of the creation and implementation of the Quality Department, documentation forms, SOPs, validations, protocols, and GMPs. •Managed the Site Quality Management System including management reviews, complaint handling, document control, calibrations, validations, internal auditing, training, manufacturing and packaging departments support, investigations and CAPA systems.•Ensured compliance with the company’s Quality Policies, cGMP, MDD/MDR Quality System requirements and with US FDA 21 CFR 111, 211, 700 and 820 regulations.•Reviewed and approved all Quality System documentation, including but not limited to Standard Operating Procedures (SOPs), Work Instructions (WI/s), Forms, Validation Protocols, Reports, Label Approvals, Deviations, OOS, Investigations, CAPAs, Manufacturing and Packaging Batch Records.•Maintained Quality Systems performance metrics.•Helped in addressing FDA 483 and Warning Letter observations.•Performed the process validations, IQ/OQ/PQ of the manufacturing and packaging areas.•Trained all quality personnel in their different job functions.•Helped in the implementation of the Supplier Qualification Program.•Helped in performing product registrations and technical information dossiers.•Helped in the launch of different product lines such as BioXGenic, Swiss Navy Desire Personal Lubricants, Swiss Navy 4 in 1 Personal Lubricants.•In charge of product label review as per FDA regulations.•Registered all the company products in the WERCS system for all the company retailers.•Helped in the introduction process of different products in retailers such as Walmart, Walgreens, CVS, GNC and Vitamin Shop by providing all the quality documentation requested by those retailers.•Helped in the new project of achieving the ISO 13485 Certification for the company.

Business Consulting in cGMP compliance, Remediation Plans for FDA 483 Warning Letters, FDA Code of Federal Regulations 21CFR Part 111, 211, 700 and 820,Process Improvements, Lean Manufacturing, Six Sigma, Value Stream Mapping, Packaging, Leadership coaching, Pharmaceuticals, Nutraceuticals and Medical Devices.

Directly managed, led, supervised and trained a team of 30 + employees within 14 Packaging linesIn charge of the daily planning and scheduling of the packaging lines

•Directly manages, leads, supervises and trains a team of 16 + employees in the Powder and Blister Packaging Departments; assign and direct the activities of packaging employees to ensure that production schedules and standards are met. Performs quality assurance checks and operations. •Supervises and coordinates activities of employees engaged in the bottling packaging process. •Responsible for directing the development, planning, implementation and maintenance of packaging processes and operations for new or existing products and technologies in a FDA and cGMP regulated environment. •In charge of the daily planning and scheduling of the Powder Packaging Lines to ensure production workflow.•Recommended and implemented measures to improve methods, equipment performance, layouts, yields and quality of production output.•Takes actions to increase efficiency and reduce costs.•Effective use of leadership and motivation tools with direct reports to obtain better efficiency and production output.•Leads or participates in troubleshooting and coordinates equipment repair to ensure least amount of down-time•Organizes and leads teams to address/resolve departmental and/or company-wide packaging issues• Formulates and recommends manufacturing policies, procedures and programs. •Created and maintained a cooperative team environment that promotes high performance standards. •Involved in developing the full potential of employees using motivational tools.

•Directly manages, leads, supervises and trains a team of 50 + employees; assign and direct the activities of packaging employees to ensure that production schedules and standards were met. Perform quality assurance checks and operations. Maintain production workflow. •Supervises and coordinates activities of employees engaged in the bottling packaging process and warehouse activities.•Effective use of leadership and motivation tools with direct reports to obtain better efficiency and production output.•Created and maintained a cooperative team environment that promotes high performance standards. •Takes actions to increase efficiency and reduce costs.•Involved in developing the full potential of employees using motivational tools.•Knowledge in the use of AS400 and APS systems.

Responsible for directing the development, planning, implementation and maintenance of packaging processes and operations for new or existing products and technologies. Supervises and coordinates activities of employees engaged in the packaging process at the Controlled Substances department.Active participation in Green Belt Six Sigma Projects and Quality Systems Enhancement Work Plan for remediation plan in response to the FDA 483.Successful launch of the Daytrana product.Helped in the increase of production output from 10,000 units per shift to an average of 80,000 units per shift.Helped in the launching of new products and implementation of new concepts such as Lean manufacturing, Lean Six Sigma and 5 "S". Led a successful Lean Six Sigma project that helped in the implementation of cost reduction initiatives of the packaging process.Recommends and implements measures to improve methods, equipment performance, layouts, yields and quality of output.Takes actions to increase efficiency and reduce costs.Effective use of leadership and motivation tools with direct reports to obtain better efficiency and production output.Organizes and leads teams to address/resolve departmental and/or company-wide manufacturing issuesSupervises the manufacture of quality products to meet customer specifications in accordance with production schedules, customer schedules, route cards and bills of material.Assists in coordinating the flow of production between shifts, and communicating all pertinent information on production activities and problems to counterpart on the next shiftHelps maintain all necessary records for the proper execution of jobs, which includes employee personnel files, job tickets, attendance records, and production recordsParticipates in training programs within the company and those sponsored outside the company which will provide self improvement

Directly manage, lead, supervise and trains team of 20 employees, assigns and directs the activities of production employees to ensure that production schedules and standards are met. Perform quality assurance checks and operations. Maintains production workflow. Ensures that tools, machines and equipment are calibrated according to production, quality and safety standards. Provides employee relations, counseling, discipline and motivation. Assist in the training of all assemblers to ensure the attainment of knowledge in the different procedures and the quality standards required by the company.Maintain accurate training records for FDA audits.Created and maintained a cooperative team environment that promotes high performance standards. Experience in lean manufacturing procedures acquired by helping in the implementation of lean manufacturing within 2 departments. Volunteered in the brainstorming sessions for the implementation of lean manufacturing at Boston Scientific.Became part of a Six Sigma team that helped in the reduction of quality incidents by 90% at the Non CV