Associate Director, Quality Systems & Quality Risk Management (QRM) @ AbbVie
Internal Audit and Risk Manager, Quality Assurance @ AstraZeneca
Senior Advisor PCQA, Global Quality & Compliance @ GlaxoSmithKline
Bachelor of Science (B.S.) @
Rensselaer Polytechnic Institute
Quality assurance and compliance professional with an extensive background in pharmaceutical process review and engineering, validation, auditing, risk management, batch release, regulatory compliance, oversight of training, and investigation of quality incidents. Strong scientific and technical expertise which allows for thorough evaluation of quality issues. Able to communicate and interact effectively at various levels both internally and externally.
Quality assurance and compliance professional with an extensive background in pharmaceutical process review and engineering, validation, auditing, risk management, batch release, regulatory compliance, oversight of training, and investigation of quality incidents. Strong scientific and technical expertise which allows for thorough evaluation of quality issues. Able to communicate and interact effectively at various levels both internally and externally. Fluent in GMPs, 21 CFR parts 11, 210, 211 and EU Orange Guide. Formally trained in Lean Six Sigma Green Belt, Certified Auditing, Computer Systems Validation and Automation. Experience with API, oral solid dosage forms, sterile injectables / biologics, and vaccines.
Assistant Director, Quality Systems - Quality Risk Management (QRM) @ • Implements Quality Risk Management (QRM) principles across the R&D organization which represents all GxP components.
• Manages broad and cross-functional quality programs, initiatives and organizational change related to the AbbVie quality systems.
• Drives transformational change and improvements with a significant impact to the organization, in a highly complex, rapidly evolving regulated environment.
• Evaluates, interprets and leads deployment and implementation of quality systems and services to ensure appropriate GxP alignments and compliance to evolving regulations.
• Develops, executes, deploys, and has oversight of R&D QA Quality Metrics / KPIs - health of the quality system. From September 2015 to Present (4 months) Greater Chicago AreaInternal Audit and Risk Manager, Quality Assurance @ • Drives a risk-based inspection program to ensure product quality as well as compliance with GxP regulations/guidelines and company quality standards across the supply chain.
• Leads internal audits of aseptic manufacturing, packaging, quality control laboratories, warehousing, facility management, supply chain, distribution, and supporting quality systems.
• Interprets findings, local incidents/investigations, and other internal or external assurance activities to identify emerging quality or GMP compliance trends or shortcomings in capability.
• Develops, leads, and manages the PA Site Risk Management Program for GMP compliance, product quality, safety, health, environment, business continuity, license to operate, and financial risks associated with manufacturing and packaging of Drug Product.
• Ensures AstraZeneca management is informed of compliance status and any significant issues or risks. Communicates with partner sites within the AstraZeneca Biologics network.
• Provides assistance, technical advice, and training in Risk Management and Auditing, and provides risk assessment support to projects or other site initiatives as needed.
• Supports and provides key leadership in US, EMA and other Regulatory Inspections.
• Develops, leads, and manages Business Continuity Plan at the PA site and conducts annual effectiveness checks. Oversees site compliance with Business Resilience.
• Leads the Compendial Method Surveillance program to ensure timely updates to QC analytical methods. Provides advice on Regulatory updates as needed.
• Manages ethical and technical related process issues impacting PA site in Ethics Point for above site reporting. From January 2015 to September 2015 (9 months) Senior Advisor PCQA, Global Quality & Compliance @ • Lead Quality Investigations / Customer Complaints ensuring that incidents have been properly detailed, root causes have been correctly identified using RCA and Lean Sigma tools, and appropriate CAPAs have been implemented.
• Lead Level 1 and Level 2 internal audits and develop detailed audit reports containing value added and appropriately scored risk-based findings.
• Lead multiple cross-functional projects of high priority including regulatory inspections and high risk non-compliance issues. Interact with European and US regulators.
• Batch Release of Drug Product to Clinical Study Sites assuring regulatory requirements are met and that product conforms to regulatory submissions/CMC details.
• Provide expert advice and consultancy to business areas and external partners on GMP regulatory issues to reduce regulatory risk to GSK.
• Proactively identify, communicate and monitor business changes that could impact quality or compliance within and across departments.
• Lead the training, education, guidance and influencing of customers/business areas in quality and compliance policy and practices.
• Identify QA, business or reputational risks associated with job responsibilities and communicate these upward along with recommendations for risk management solutions.
• Develop and incorporate effective processes and procedures in GQC and contribute to business processes and procedures outside GQC.
• Manage a PCQA team to perform GEMBA walk throughs of critical business areas to develop process improvements and identify gaps.
• Represent the PCQA group as a primary contact for PTS Global Demand and Supply issues.
• Assure compliance with GMPs and the GSK Quality Management System (QMS).
• Embed a culture of Rigor and Discipline, focus on Quality for the Patient and share learnings across groups as a member of the UM/UP Quality Council and Q4tP team.
• Line management and supervisory experience of contract workers. Responsible for training of junior staff members. From February 2005 to January 2015 (10 years) Lead Validation/Automation Engineer @ • Validation Projects for GSK – Environmental Monitoring System, BioPharmaceutical Cell Banks, WFI System, Homogenizers, and other BioPharmaceutical process equipment.
• Automation Project for Johnson Matthey – Batch and Blend System
• Automation Project for AMGEN, Inc. – Chromatography Skid From 2003 to 2005 (2 years) Process Automation Engineer @ • Interpreted and modified existing RSLogix code and composed Functional Design Specification documents for Cell Culture Robots in Varicella unit at Merck & Co., Inc.
• Performed Automation Change Controls for code updates on process equipment in the Varicella Expansion unit at Merck & Co., Inc. using the control studio lab in DeltaV 6.0.
• Performed testing of equipment and instrumentation in control monitoring areas.
• Worldwide Atypical Tracking System and Document Compliance System Administrator. From 2002 to 2003 (1 year) Materials Management Intern @ From May 2001 to August 2001 (4 months) Automation Technology Intern @ From May 2000 to August 2000 (4 months)
Master of Business Administration (MBA) @ Temple University - Fox School of Business and Management From 2015 to 2018 Bachelor of Science (B.S.), Chemical Engineering, 3.8 @ Rensselaer Polytechnic Institute From 1998 to 2002 Joseph Gotowko is skilled in: Pharmaceutical Industry, cGMP manufacturing, GMP, Computer System Validation, Validation, Process Improvement, Six Sigma, Program Management, Technical Writing, FDA, Biotechnology, Automation, Laboratory Automation, Lean Tools, DMAIC
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