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Resume Mariangeli Diaz http://yogati.com/file/profesionales/resume-mariangelidiaz2016.doc
Mariangeli Díaz Salgado 15273 Westbridge Ct. Henderson, MD 21640 M - (787) 501-4029 H - (443) 262- 8228 mariangeli.diaz@hotmail.com
Professional Background: Global Consultant with +26 years of experience in the Pharmaceutical, Biotech, Food, and Medical Device Industries. Extensive experience in Regulatory Compliance, FDA, ISO22000-2005/ISO 9001-2008/13485-2003, cGxP’s, OSHA, EPA, EHS, USP/NF, JP, EP, Quality Systems Part 210-211 & 820, Planning and Auditing, PFMEA and Risk Assessment evaluations, among others. Strong leadership skills with an analytical mind to solve quality issues. Ability to promote and maintain a high level of quality competence and staff motivation to accomplish objectives and meet deadlines. Hands-on experience as Quality Assurance Manager, Technical Services Director, Change Control Manager, and Project Manager, with knowledge in Quality Systems, Validation, Manufacturing Operations, Product Transfer, and Regulatory Compliance programs. International work performed in USA, Dominican Republic, Mexico and Puerto Rico. Successful completion of million dollar projects through project estimate, planning, budgeting, cost control, implementation, execution and closeout. Built outstanding client relationships. Supervised, directly and indirectly approximately one hundred (100) manufacturing, quality, and validation professionals. Fully bilingual. Proficient in computerized systems such as: MS Office, Kronos, Project Management, SAP, JDE, ISOtrain, Documentum SOP System, and TrackWise System. Indian Business Visa, effective until Apr 2019.
Key Projects and Accomplishments
The Quantic Group, Ltd., Livingston, NJ, 2011 – Present Sr. Quality Leader on India sites - FDA Warning Letter Remediation
· Independent third party - Regulatory Services Group o Quality Assurance Remediation Plan Lead o Establish and evolve formal QA processes, ensuring that the client follow industry-accepted best practices. o Oversee all aspects of quality assurance in 3 sites including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality commitments are met. o Act as key point of contact for all QA aspects to establish a site wise harmonization. o Lead and mentor Site QA team members, as well as manage outside remediation team. o Develop and execute remediation protocols to full fill the sites commitments. o Review and evaluate performance issues with up to 10 direct reports o Interact with customers during meetings and visits o Collaborate with other Areas staff to accomplish all daily tasks on-time with a high level of quality
Leader on U.S. site FDA consent Decree Remediation · Independent third party - Regulatory Services Group o Audit remediation activities against the Consent Decree Workplan, Quality Standards, FDA, cGMPs, applicable laws and regulations. o Ensure Remediation Steps comply and meet the Seven Attributes of a Quality System (Process, Procedures, Documentation, Quality Role, Organization, Infrastructure, and Metrics). o Review Traceability Matrix to determine which gaps, findings, 483 Observations, and CD requirements are addressed by the Numbered Step. o Inspect the facilities to determine if the methods, facilities and controls are operated in conformity with cGMPs, and if maintained, will continuously comply with the FDA, cGMPs, applicable laws and regulations. o Categorize findings and develop the respective reports.
· Change Control SME - Interim Controls Group o Provide coaching and mentoring to the Change Control Program originators and administrators. o Evaluate Change Controls and certify such, if in compliance, prior to quality approval. o Evaluated existing Change Control process and support the workshop activities. o Provide guidance to Quality System Teams throughout the remediation process.
o Intervet Schering-Plough Animal Health, S.A. de C.V., Santiago de Tianguistenco, Mexico 2009 - 2011 · Responsible of managing Remediation Project for specific product. · Implemented remediation activities for Manufacturing, Validation/Calibration, Quality Control, Quality Assurance, Quality Management and Warehouse areas. · Supervised and provided management and technical support to seven (7) Validation Engineers. · Scope includes manufacturing batch record review, standard operating procedures, validation activities (Installation, Operational and Performance Qualification) for manufacturing and quality control systems. · Provided Technical and Quality support to the organization.
o Glaxo Smith Kline, Cidra, Puerto Rico 2006 - 2008 Managed and developed Compliance Programs under FDA Oversight, per Consent Decree requirements. Compliance Programs consisted of: o Regulatory Compliance-Quality Management Team Leader
o Lilly del Caribe (PR05), Carolina, Puerto RicO 2004 - 2005 Commissioning and Validation Project Manager
· Supervised and provided management and technical support to twenty (20) Validation professionals. · Managed the implementation, recruiting and management of Quality Requirements/Platform, Quality Assurance Technical and Execution Incident Teams. · Lead the coordination of the qualification activities. · Prepared project controls, budgeting, scheduling, staffing, weekly and monthly status reports, as required by the client. · Responsible for the staffing recruiting process and sub-contractor’s coordination.
o Nypro, Dominican Republic 2002-2004 Sr. Tech Transfer Director · Lead the transfer activities for products from development to manufacturing. · Lead multi-functional Operations Transfer Teams to define and complete activities required (create specifications, test methods, manufacturing batch records, validation protocols, and reports as needed) for scale up, validation, transfer to manufacturing, and launching new products. · Responsible of PAI submission, post and pre-approval inspection. · Performed Supplier evaluation and Certification. · Provided regulatory guidance for top-level project development and core teams. · Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development. · Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigate manufacturing deviations. · Managed all project activities and timelines for the Product Transfer Program within the Technical Services department. · Managed $28-million-dollar project budget.
o SCHERING PLOUGH 1999-2002 Process Certification Director
· Developed, implemented and executed regulatory strategic plans for the Pharmaceutical Product Re- Certification under FDA Oversight due to the Consent Decree. · Carried out responsibilities in accordance with the organization policies, procedures, and federal, state and local laws. · Developed and documented validation project plans / schedules and validation procedures based on sound validation practices and current industry standards. · Managed all process validation projects, activities and timelines for the Validation Certification Program within the Technical Services department. · Responsible for the generation and execution of process validation protocols, performance qualification protocols per related Standard Operating Procedures (SOP's). Assured the acceptance criteria related to these protocols was met. · Reviewed and approved validation / qualification protocols and summary reports completed by the Technical Services department and other departments. · Analyzed data, specifications, and basis of design or functional specifications to determine conformance with standards and established quality requirements. · Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas. · Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development. · Ensured compliance with all company policies and procedures, including safety rules and regulations.
o MDS UNLIMITED CONSULTING SERVICES CORP. 1994 - 1999 Validation & Quality Consultant
o Validation Manager
· Supervised, mentored and trained fifteen (15) junior level validation consultants. · Responsible of the execution and implementation of projects that supported the manufacturing operation, including projects involving marketed product development, marketed product development, marketed product support and technology transfer. · Accountable for the project design and coordination, including development of protocols, design of experiments, data analysis and implementation of optimized manufacturing process and qualification of alternate raw materials, excipients and components. · Assessed production problems at component preparation, formulation, filling, sterilization cycle and lyophilization stages by performing investigations, identifying the root causes and developing solutions. · Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies.
o Quality Assurance / Documentation and Change Control Manager· Developed, implemented and maintained standard policies, procedures and controlled document systems, ensuring global level compliance with current good manufacturing practice regulations. · Responsible for harmonizing document control procedures throughout the corporation. · Participated in companywide projects that heavily impacted existing or proposed controlled documentation and provided facilitation to the project members, to ensure timely completion of these documents. · Managed off-site storage and retrieval of controlled documents. · Assisted in the development and implementation of document retention policy consistent with corporate policy. · Managed the corporate electronic document management system (BEN). · Managed all controlled document archives at manufacturing sites. · Developed and implemented a program for electronic documentation archiving. · Provided mentoring on general Quality Assurance systems/procedures (deviation systems, CAPA, etc.). · Gave technical support to Manufacturing Operations in different business units including: Dermik, Aerosols, and Solid Dosage. · Evaluated and improved the manufacturing documentation processes. Utilized statistical process control and other tools to assess the performance of the process and implement specific actions to enhance control and achievement of specifications.
o Pharmaceutical Technologist Scientist· Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies. · Provided scientific technical support to Manufacturing, and lead the Technology Transfer Process. · Acted as a manufacturing technical liaison between Company Headquarters and other sites. Assured that the scale up of products from R&D or products transferred from other sites were accomplished with minimal confusion and disruptions. · Wrote, executed and coordinated protocols for process, holding time and cleaning validation. Wrote Working Formula Procedures. · Troubleshoot manufacturing problems and provide solutions to day to day incidents and problems. Perform statistical evaluation of process variables. Interpret data, information and regulations. · Utilized project management skills to ensure timely and successful completion of assigned projects. Provided training to production personnel in new technologies. · Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas. · Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development. · Ensured compliance with all company policies and procedures, including safety rules and regulations. WARNER LAMBERT, INC 1988 - 1993 Compliance Coordinator · Audited Manufacturing Areas to assure GMP's Compliance, ISO 9000. · Developed the Supplier Certification Program. · Developed the Compliance Certification Plan, according to the FDA requirements. · Audited and Approved Validation Protocols (IQ, OQ, PQ, Computer and Cleaning Validation). Education and Professional Development BS, Science Microbiology, Interamerican University of Puerto Rico |
