ROBERT E. SPARADOSKI

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*** ******* **.

Evanston, IL 60201

ady7sz@r.postjobfree.com

http://www.linkedin.com/pub/robert-

sparadoski/a/627/346

Cell: 201-***-****

QUALITY MANAGEMENT EXECUTIVE

A seasoned quality executive with a solid performance and proven track record in Quality Management leadership transcending the Medical Device and Pharmaceutical industry. As a Quality thought leader, improving quality management systems, audit readiness, supplier quality, and quality leadership I have satisfied Quality, Business, and Compliance objectives aligned to 21CFR part 11, 200, 210, 820, ISO 143485, ISO 14971 and EU GMP Annex 1 requirements. My extensive Lean Six Sigma experience enables me to drive the reduction of both product quality issues and Quality Management System deficiencies. My proven leadership skills have consistently led to the establishment of successful high functioning teams and the development of future company leaders. ACCOMPLISHMENTS

Larry Bossidy (CEO) Individual Special Recognition Award: Significant Allied Signal contributions - $46M effort

Fred Hassan (CEO) Distinguished Contributors Award – Schering-Plough Consent Decree

Certified Black Belt Six Sigma Process Improvement Leader

Enabling Technologies Award: Outstanding support to Honeywell Specialty Chemicals: API Support

NJ PMP Chapter - Project Management Institute Recognition

Individual Special Recognition Award: Individual and Leadership Customer Commitment

Special Recognition Award: “Worldwide Demilitarization” Krasnoyarsk, Siberia, Russia

Senior American Society for Quality Member

PROFESSIONAL EXPERIENCE

Director of Quality – Regis Technologies Inc., Morton Grove, IL Oct 2022- Mar 2023 Responsible for establishment and management of all aspects of Regis’ quality management systems, performance monitoring of GMP operations, and QC laboratory while ensuring API and R&D manufacturing operations perform in a state of control aligned to ICH Q7 and 21CFR210, 21CFR211 requirements. 3 direct and 24 indirect associates.

Supported the 2022 FDA Inspection and provided a comprehensive and timely response.

Provided DMF revision and regulatory registration guidance.

Developed functional Quality (QA and QC) KPIs and reported at Board of Advisors meetings.

Provided Batch Record Error Reduction Training from 65% to 85%

Provided Proper Investigation and Root Cause Analysis Training Sr. Director Quality Assurance – Wockhardt Group; Morton Grove Pharmaceuticals, Morton Grove, IL Feb 2019 – Aug 2022

Responsible for providing Quality leadership and direction of Quality Management Systems departments including Batch Release, Document Control, Validation, Change Control, Deviations, Supplier Quality, CAPA, and Training ensuring all departments were in compliance with cGMPs, FDA guidelines, SOPs, and company policy supporting safe and efficacious drug products manufactured and commercialized. Successfully managed 8 direct and 26 indirect associates.

Supported FDA Inspection Readiness and FDA Inspections from SME training to Inspection Management.

Managed the Inspection Preparedness Program and Inspection Management.

Supported and managed the Quality Management Systems through Quality KPIs,

Developed QA for QC functions for Data Integrity reviews prior Batch Release.

Created a Global Investigation Certification Program. Site Quality Director – Regulatory Compliance Associates – PharMEDium LLC, Dayton NJ / Lake Forest Illinois

- May 2018 – Jan 2019

Responsible for designing, planning, implementing, directing and evaluating a quality assurance function and quality management systems for regulated activities provided across PharMEDium.

Implemented and continually assessed the quality function and quality management systems. ROBERT E. SPARADOSKI

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Managed the Inspection Preparedness Program supporting PAI, GMP, and For-Cause Inspections.

Implemented short-term and long-term strategies, goals, objectives, and tactics relating to quality assurance.

Recommended appropriate corrective action to ensure consistency with the quality assurance function and regulatory requirements.

Implemented continuous improvement plan for growing and maturing the quality assurance function.

Supported quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities. Pharmaceutical Consultant- Insight Global, Sanofi Pharmaceuticals, Bridgewater NJ, 2016 – April 2018 Assisted in the development of strategies, tactics, trainings, programs, and activities related to assuring compliance with Quality Operations Management Systems regulations. Supported the expansion of a strong quality culture across North America Quality, Cold Chain, and Samples Operations successfully leveraging cross-functional stakeholders.

Provided harmonized improvements for quality systems to enable sustained performance in support of the organization's broader continuous improvement initiatives.

Served as an integral member of the North America Quality team by driving the continued and measured success for quality assurance related Quality Agreements, Deviation and CAPA Management and reporting Metrics.

Drove improved KPI Metrics Visibility/Transparency across Sanofi US LLC.

Supported Quality reporting activities aligning goals and objectives.

Acted as SME in the development and implementation of quality systems, procedures, and business standards that comply with US, International, Sanofi US LLC, and Sanofi Global Quality standards. Associate Vice President QA Compliance, Ferring Pharmaceuticals, Parsippany, NJ 2014 to 2015 Head of US Quality supporting many platforms including the injectable business to include oncology, diabetes, growth hormones, medical devices, and syringe free platforms. Responsible for the execution of all Quality Management Systems and GMP alignment to EU GMP, 21CFR 200 & 210 21CFR 820, ISO 13485, and ISO 14971 regulatory requirements for both internal and external manufacturing. Successfully managed 5 direct and 35 indirect associates.

Successfully managed End-to-End QC and QA/QC processes aligned to regulatory requirements.

Supported RA efforts aligned with Injectable/Combination/Medical Device UDI and GMDN requirements.

Developed, implemented, and managed third party inspection management program.

Managed the Inspection Preparedness Program for PAI and GMP / EU GMP Inspections.

Served as an integral member of the team by driving the continued successful quality assurance related to the commercialization of various product platforms.

Developed strategies, tactics, training's, programs and activities related to assuring compliance with regulations, investigations of product complaints/incidents, certification of vendors, and transfer of products and technology.

Senior Director QA Compliance, Valeant Pharmaceuticals, Bridgewater, NJ, 2012 to 2014 Oversaw Valeant Pharmaceuticals North America LLC QA/QC related activities for all external manufacturing assuring QA Compliance to 21CFR 200, 210, EU GMP, requirements. Valeant was a virtual pharmaceutical company utilizing CMOs as an extension of QMS and GXP functions. Successfully managed 15 direct and 115 indirect associates.

Managed drug product compliance to US (21 CFR Part 210 & 211,/ EU GMP, and ICH Guidelines (ICH Q7-10) and 21 CFR part 11 compliance providing a flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management to assimilate new products and business.

Management Representative for Medical Devices achieving successful CMO vendor partnerships aligned to ISO 13485, ISO 14971, 21CFR 820, ISO 13485, ISO 14971, 21CFR820, Council Medical Device Directive (MDD), Canadian Medical Device Regulations SOR/98-282 (CMDCAS), JPAL, etc. requirements.

Managed the Inspection Preparedness Program for PAI and GMP Inspections.

Responsible for the success of GMP QA Compliance programs across over 100 CMOs.

Actively pursued new business opportunities through product and company acquisitions and assimilation. WW Director Quality Operations, Becton Dickinson, Franklin Lakes, NJ, 2006 to 2011 ROBERT E. SPARADOSKI

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Realized operational and compliance benefits in Quality Operations Management, Validation, and Continuous Improvement initiatives across 17 global locations. Supported injectable, combination, and medical device businesses aligned to 21CFR820, and EU GMP requirements. Successfully managed 17 direct and 250 indirect associates.

Responsible validation program leader across 17 global locations deploying validation strategies and site validation leaders.

Hosted FDA, ANVISA, KFDA, MHRA, Turkish Ministry of Health and Medical Device Notified bodies BSI and NSAI in US and global locations (Columbus, NE; Las Piedras, PR, Juncos, PR; Juiz de Fora, Brazil; Gumi, Korea; Fraga, Spain; Helsingborg, Sweden; etc.) aligned to ISO 13485, ISO 14971, 21CFR820, Council Medical Device Directive (MDD), Canadian Medical Device Regulations SOR/98-282 (CMDCAS), JPAL, etc. requirements.

Provided quality compliance remediation guidance in Puerto Rico, NLA, SLA, EMEA, and AsiaPac regions by standardizing operational policies and procedures.

Partnered with key SME functions supporting IGQA- Initiative for Great Quality Auditing that included all end-to- end processes (Planning, Performing, and Managing, Training, and Auditor Qualification process).

Implemented a harmonized audit management program across 17 global locations resulting in less inspection preparation including forms, documents, and responses as controlled documents.

Reduced Validation cycle time and Change Management by 50%.

Supported continuous improvement and compliance remediation activities and effectively identified issues within Quality Systems realizing a reduction of 35%.

Realized new product offering’s satisfying unmet needs in China, India, and Brazil responding to low cost competition by working with global executives to realize increased multi-plant capacity utilization.

Provided input and support for ~$4.5M annual budget process. Director Quality Operations Management and Planning, Schering-Plough Inc., Kenilworth, NJ, 2003 to 2006 Responsible for Continuous Improvement, Quality Management and Planning responsibilities and leadership supporting the Consent Decree which included: NJ Site Quality Council, NJ Site Business Council, 23 Quality Systems Management Performance, project management, regulatory compliance, and business improvements deploying cGLP/cGMP requirements. Successfully managed 525 indirect associates.

Provided leadership and direction supporting the execution of the Consent Decree Work Plan as New Jersey Quality Management Systems sponsor using Six Sigma and Lean principles.

Supported GLP and GMP processes through regulatory curricula based training.

Supporting the Supplier Improvement Process (SIP) enhanced Six-Sigma approach as Schering-Plough’s Turn-Around-Strategy.

Oversaw and reviewed all processes and procedures. Interacted with internal and external clients to create and finalize documentation, investigations, and reports. Developed and maintained Quality Systems in accordance with FDA and cGMP standards.

Supported continuous process improvement efforts and developed Six Sigma training modules.

Developed NJ Business Council – improved communications of key projects enhancing NJ Quality and Supply Chain Operation business performance and various key performance indices based on prioritization of Six Sigma projects improving Right First Time Metrics.

Evaluated and Implemented a WEB based time management application for 525 associates. Global Quality Business Leader, Honeywell International, Specialty Materials, Morristown, NJ 1998 – 2003 Accountable for project management, quality management, acquisition of PFC (Pharmaceutical Fine Chemicals) technology transfer between Ireland, Italy, and Bahamas achieving business and corporate objectives. I enjoyed process optimization, project management, and quality leadership accomplishments and was recognized by CEO Larry Bossidy.

Effectively managed Mass Spectrometry and Analytical Chemistry laboratory operations.

Maintained and supported quality criteria and certifications across SB’s.

Global CoE Leader – Validations, Technology Transfer, SOPs, and effective control plans.

Leveraged global quality systems and process optimization “Best Practice” policies. ROBERT E. SPARADOSKI

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Global Leader – Center of Expertise – Leveraged “in-sourced” global opportunities.

Created global technology transfer methodology global API manufacturing technologies.

Successful completion of $46M Rocket Fuel Conversion Project – Siberia, Russia leveraging Six Sigma skills. PUBLICATIONS AND PRESENTATIONS

Chair - 13th Annual Product Complaint Congress, Washington, D.C. June 23-25, 2015 (FDA, Industry Leaders, and supporting QA cross functional attendance).

Co-chair of the American Biomanufacturing Summit in San Diego, CA May 13-14, 2015.

Key Note Presentation at the 13th Annual Biological Production Forum, May 13-15, 2014, Dublin Ireland “How Valeant Pharmaceuticals Manages numerous CMOs”. Published - Outsourcing-Pharma.com May 13th 2014.

Chair and Presenter: IQPC Conference – “Lean Six Sigma for Pharmaceutical and Biotech Manufacturing Excellence” – "SIP"(Supply Improvement Process) Provides the Model for Transformational Change as the Enabler of "Right First Time" - Reduce rework and eliminate deviations, while continuing to maintain the highest standards of compliance and quality – Feb 27-Mar 1, 2006, Philadelphia, PA.

“Hybrid New Product Development Strategies”, Engineering Management Journal. 10 (1998) 41.

“Isolation and Identification of 3-Carbamoyloxy-2-phenylpropionic Acid as a Major Human Urinary Metabolite of Felbamate”, Drug Metabolism and Disposition 21 (1993) 710.

Presentations at the 40th and 41st ASMS Conference on Mass Spectrometry and Allied Topics, Washington DC and San Francisco, CA 1992 and 1993 respectively. EDUCATION

Executive Masters of Technology Management, Stevens Institute of Technology, Hoboken, NJ

BA, Bachelors of Arts, Botany/ Biological Sciences, Rutgers University, Rutgers College, New Brunswick, NJ

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