I help companies manage US GMP compliance and protect their brands while driving growth ambition by ensuring there is a strong quality management system that effectively controls their operations. I provide quality guidance, risk assessment, and management throughout the product lifecycle. I promote a culture of quality, excellence, transparency, work ethics, and enhance teamwork. I develop and maintain collaborative relationships with internal and external stakeholders. I have the ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment. I develop direct reports, promote team engagement, and improve both functional dexterity and business alignment.I believe in making a difference with a focus on execution, attention to detail, communication, and preparedness to meet deadlines accompanied with analytics and reporting for insight. I love developing new products that consumers love and enjoy. I have done GMP audits for multiple brands, created corporate-level audit policies, collaborated, and synergized audit processes & strategies across brands to ensure GMP compliance.I am a Master of Business Administration with a Major in Business Management from the Florida International University and have a Bachelor’s degree in Science in Mechanical Engineering from Simon Bolivar University. I have a hands-on approach within the pharmaceutical and dietary supplements industry with an entrepreneurial spirit that seeks to create a seamless integration of processes with quality. I am highly adept at working on projects with multinational cross-functional teams. One of my recent achievements is where I generated, implemented, and trained the US team on a new QMS, based on ICH guidelines and QA best practices. I adapted global procedures, created new US procedures and forms that resulted in 100% QMS compliant with FDA regulations. My Specialties - Quality Compliance | Quality Performance | 3rd Party Quality Management | Consumer & Regulatory Trends | Performance KPI’s | Regional & Global Procedures Management | Quality Monitoring | Quality Management Review | New Product Development | FDA regulations | 21 CFR 111, 210 and 211 | CGMP standards | End to End Quality Strategy | Quality Framework Key Competencies:Team LeadershipVerbal and written communication skillsProcess Improvement Project Management R&D Quality Management Audits / Inspections Stakeholder Management
Consulting Associates Gmp
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Consulting Associates GmpMiami, Fl, Us
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Quality Assurance & Regulatory Manager | Quality Compliance ManagementStada Corp Usa Jan 2021 - Feb 2022Summit, New Jersey, UsManaged Quality Assurance and regulatory affairs for STADA Corp, a multinational pharmaceutical and dietary supplement company globally recognized for its quality products and leading consumer brands. • Created, managed & implemented QA procedures, strategies, policies, and established objectives in accordance with company strategic plans to ensure compliance with US GMPs to protect the brands while driving growth ambitions. • Developed and executed robust end-to-end Quality strategies, including the creation of the QMS and SOP’s. Inspected and conducted audits to CMO’s, distributors and warehouses to ensure compliance with regulations and, represented the company on different forums. • Collaborated and worked with internal & external partners to ensure appropriate quality management framework is in place to guarantee end-to-end Quality compliance for the business.• Ensured a 100% compliance of all the 3rd parties with Global and regional requirements by conducting virtual, on-site audits, and inspections to all 3rd party manufacturers, distributors and warehouses. -
Quality Assurance And Regulatory Manager | Qa | Regulatory Management | Regulatory ComplianceAmerichem Pharmaceutical Corp Mar 2017 - Jan 2021Doral, Florida, UsManaged QA and regulatory aspects of pharmaceutical products and raw materials for this top global distributor.• Led quality assurance activities for pharmaceutical products including procurement, warehousing, transportation and distribution. Achieved 100% approval from multi-national organizations audits and inspections. • Performed in-depth analyses, identified opportunities, developed effective strategies and designed new quality processes based on market and regulatory demands.• Created a complete QMS compliant with FDA regulations 21 CFR parts 110, 210, 211, IPEC, & GDP guidelines that pass all the inspections received from multinationals companies ensuring business continuity, and growth. -
Quality Assurance Manager | Quality Compliance | Regulatory ManagementPharmalab Mar 2015 - Feb 2017Ensured the production of high-quality products for this top contract manufacturer of premium pharmaceutical, OTC, and dietary supplement brands for the US market.• Managed the QA department and maintained a culture where all activities, including the manufacture, storage, release, and distribution of pharmaceutical, cosmetic and dietary products were compliant with FDA and federal regulations.• Oversaw the production of 100+ OTC and dietary supplement products and ensured top quality assurance management.• Passed FDA inspections without any 483’s ensuring compliance with all 21 CFR part 111, 210 and 211 regulations through effective management of CAPA, deviations, change controls, investigations and continuous improvement of the QMS for all the pharmaceutical and nutritional products.• Conducted audits and inspections to suppliers and kept control of all records. Managed OOS, laboratory controls, investigations, analyses, process validations and stability studies.
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Project ManagerNational Institute Of Health Aug 2012 - Oct 2014Lead the extraction systems project from design to full implementation at the vaccines manufacturing facility.•Managed the activities of the project team, oversaw project budgets and ensured end-to-end project success.•Performed quality inspections and implemented cost savings plans ensuring compliance with GMP requirements.•Managed the design and installation of the extraction system of the Vaccines Production Plant and successfully implemented cost savings achieving a reduction in overall costs.
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R&D Product Research EngineerProcter & Gamble Jul 2010 - Jul 2012Cincinnati, Ohio, UsAs an R&D Product Research Engineer for the Oral Health Care Department in Latin America, oversaw several consumer research projects for the Crest and Oral B Brands in Latin America. • Managed a multinational team and coordinated activities between the R&D technical team in China, the Finance & Product Supply teams in Panama, the Management team in Cincinnati, USA and the Manufacturing team in Brazil.• Successfully translated consumer needs into consumer-driven innovation strategies and managed the development and launch of such solutions often on very limited budgets; for instance, led the introduction of the Crest Family Protection brand in Mexico and the Oral B123 brand in Brazil. • Demonstrated innovative approaches in the envisioning and delivery of products based on robust technical plans that improved product Total Delivery Cost (TDC) in the low tier segment while ensuring widespread consumer acceptance. • Conducted focus groups, sensory panels, and large consumer researches in Mexico and Brazil. • Lead the Crest Toothpaste 123 program and developed learning and technical readiness plans that resulted in the identification of suitable flavor options to generate a new flavor extension for Crest and Oral B 123, subsequently delighting consumers in Latin America. -
R&D Process Development EngineerProcter & Gamble May 2009 - Jun 2010Cincinnati, Ohio, UsOnboarded at this global leader of consumer goods to provide support to process engineering for the Personal Health Care Department in Latin America with a focus on the Pepto Bismol Brand. •Lead the Pepto Bismol manufacturing process development activities and implemented a new skid manufacturing process that enabled an increase in production and a reduction in production time, while remaining compliant with CGMPs and local regulations.
Cristobal Gonzalez Skills
Cristobal Gonzalez Education Details
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Florida International UniversityGeneral -
Simon Bolivar UniversityMechanical Engineering
Frequently Asked Questions about Cristobal Gonzalez
What company does Cristobal Gonzalez work for?
Cristobal Gonzalez works for Consulting Associates Gmp
What is Cristobal Gonzalez's role at the current company?
Cristobal Gonzalez's current role is Quality Assurance | Regulatory Management | GMP/GDP Quality Compliance | I help companies protect their products by ensuring robust quality management & regulatory systems that contributes to effective operations.
What schools did Cristobal Gonzalez attend?
Cristobal Gonzalez attended Florida International University, Simon Bolivar University.
What skills is Cristobal Gonzalez known for?
Cristobal Gonzalez has skills like Product Development, Manufacturing, Engineering, Project Management, Project Engineering, Process Engineering, Microsoft Office, R&d, Product Design, Solidworks, Autocad, Management.
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