Robert Mancuso Email & Phone Number

Canada

Leading the Quality program for GMP / GDP compliance, regulatory and industry compliance in Canada.Continuous process improvements for efficiencies in executing QMS.

Toronto, Ontario, Ca

Governed and drove regulatory compliance requirements across 13 operational sites - Chaired the Global Compliance Management forum to effectively prepare all sites for inspections - Improved investigation and CAPA processes, systems and Investigator/Approver Certification training- Continuous improvement of global certification training programs and delivery to eligible employees- Optimized the global policies and standards to align with current regulatory guidance documents- Directed strategic initiatives / governance, coached and mentored team of 24 employees- Accountable for delivery of all global certification training programs and training records in Global Learning Management SystemProvides strategic direction to harmonize compliance programs across all Global Sites for establishing and enhancing compliance programs to ensure proactive / effective execution, governance, and enforcement at all sites across Apotex.

Toronto, Ontario, Ca

Drove compliance, regulatory inspection preparations and risk management across 13 operational sites – Enhanced the quality and compliance or investigations, monitored effectiveness for sustainment- Expanded outreach & budget for Seneca College employee training program globally- Successfully launched cloud-based Learning Management System globally- Streamlined global policies & standards document collection to simplify site implementation- Successfully simplified all global training programs (new employee orientation; certifications programs for investigations, audits, microbiology; controlled substance management, CAPA)- Held team accountable for escalation of patient risk of critical incidents for recall recommendations, drug shortages, product risk assessments- Consistently accountable for training and enabling team members to effectively perform dutiesSenior leader of 3 teams in Global Quality & Compliance engaged in enterprise Quality System management, delivering GMP training and certification programs, implementation of global quality policies and standards to sustain compliance.> Delivered enhancements for Quality Systems, most notably for Excellence in Investigations

Toronto, Ontario, Ca

Drove compliance, regulatory inspection preparations and risk management for Oral Solid Dose (OSD) operational sites at the Head Office Signet Campus> Designated as Interim Site QA Head maintained inspection readiness of all quality systems;- Successfully hosted all regulatory inspections, customer and corporate quality audits- Sustained compliance operational targets as Interim Site QA Head- Supported patients via Special Access Program & Compassionate Drug Program- Strengthened compliance of Specialty Products facility for Low PDE products- Successfully achieved and sustained on-time closure of Deviations, CAPA, Complaints, Audit Reports, Annual Product Reviews- Held team accountable for escalation of patient risk of critical incidents for recall recommendations- Accountable for training and enabling team members to effectively perform dutiesQuality Assurance member of the Signet Site Leadership Team, accountable for spearheading the quality vision at Signet Campus in collaboration with stakeholders from all levels of the operations to sustain the compliance status. • Responsible for continual development, direction and execution of the Quality standards in compliance with all applicable regulations and manage risk to sustain a state or inspection preparedness. • Directed continually improve the Quality Unit via execution of quality systems (deviation, Change and CAPA management), Quality Control, regulatory/client/internal/external audit program, quality document management, validation compliance and training.

Toronto, Ontario, Ca

Drove compliance, regulatory inspection preparations and risk management at the sole sterile & liquid dose operational site- Achieved & sustained on-time closure for investigations, complaints, CAPA, Annual Product Quality Reviews- Directed the liquid dose site to achieve unprecedented 'zero' observations outcome in FDA inspection- Successfully achieved and sustained on-time closure of Deviations, CAPA, Complaints, Audit Reports, Annual Product Reviews- Held team accountable for escalation of patient risk of critical incidents for recall recommendations- Accountable for training and enabling team members to effectively perform duties

Paris, France, Fr

Deputy Director, Quality Operations – Quality Systems (Affiliate Quality Officer) from Nov 2012 to Sep 2013Responsible for site recall escalation management, metrics (Key Performance Indicators), continuous improvements on quality systems, designated host for regulatory inspections and global quality audits.Deputy Director, Quality Operations - Operational Quality from Apr 2004 to Nov 2012Achieved progressive roles and experience in the quality leadership at the Toronto Connaught Campus- Influenced development of global quality documents by best practices in quality management systems- Enhanced and redeveloped quality systems to deliver strategic compliance support to the business- Directed multi-disciplinary project teams to consistently deliver annual operational / corporate objectives- Appointed Affiliate Quality Officer at Sanofi Pasteur Limited (Toronto)- Directed quality management of Health Canada’s NESS Depot for Smallpox Vaccine Bio-Terrorism Stockpile- Successfully drove SAP QM quality systems and e-signature implementations- Actively chaired the Material Review Board for executive review of critical incidents from 2005 to 2013- Spearheaded Quality Systems implementation (deviations, audits, change, audit); Cold Chain Management- Collaborated with senior leadership on Strategic Long-Range Plan, SMART objectives and driving successful execution of deliverables

Paris, France, Fr

Actively managed the Change Control, Logistics and Supplier Audits responsible for performance, recruitment, termination, training, human resource issue resolution and distribution of work load among 3 direct reports to ensure timely deliverables for customer satisfaction.> Process Owner and Chairperson of Change Control application;successfully lead the design, build and qualification> Launched the Sample Management team and SAP system application until successful transfer to QC in 2007> Master Seed Bank Owner from 1998 until successful transfer to Manufacturing Technology in June 2005> Achieved Materials Management Class A; expanded Contract and Supplier Management programs.

Paris, France, Fr

Actively managed performance and coached a team of 13 direct reports to ensure site compliance and risk management through quality systems.> Owned the Quality Systems: Investigations, Self-inspection, Vendor Audits and Change Control;> Quality and Compliance lead in problem solving technical challenges in manufacturing and QC testing;> Developed quality policies, specifications, SOPs and improvement projects for each quality system

Paris, France, Fr

Responsible for providing compliance support, performing audits of the Bacterial Vaccines manufacturing, Quality Control Immunology, Bacteriology, Sterility, contract production and test facilities GMP/GLP compliance.> Lead Investigator - deviations root cause analysis of OOS, sterility/stability OOS, CAPA and disposition;> Quality lead for system and equipment Change Controls; approved master SOPs, batch records.

Bachelors Degree, Microbiology & Biochemistry

Osshgd, Biological And Physical Sciences