Quality Systems Management

Karl Kovacs

Bedminster, NJ ***** **********@*******.***

GLOBAL CGxP QUALITY MANAGEMENT SYSTEMS LEAD

Leverages Quality Management Systems to drive operational excellence

Proven success in enhancing quality systems, ensuring compliance, and

fostering continuous improvement across global supply chains

EXPERIENCE

Crowne Pharmaceutical Consulting Services

Governance, oversight and support of OTC, pharmaceutical, diagnostic and combination products

CGxP Quality Management Systems Lead 2008 – current

(Documentation, Training, Event Management, Investigation, CAPA & Change Management Systems)

HISTORY OF CONTRIBUTION INCLUDES

Quality Leadership

As MBA student: Learned the challenges and opportunities of Learning Organizations and Reliability Organizations

As Site Quality Lead: Communicated by example that Quality and management were each employee’s responsibility

Result: Increased ratio of Preventive Actions (PA) to Corrective Actions (CA) Created an employee Suggestion Program

Motivated and inspired Site personnel to develop a Best-First-Time Quality Culture

Result: Decreased batch documentation review period by ~50%

Result: Decreased in-process and finished goods’ reject rates to ~0%

Result: Enabled a Learning Organization’s Continuous Improvement culture

Result: Embedded a Reliability Organization’s Continual Improvement culture

Result: Operations and culture transformed from reactive mode (CA) to proactive mode (PA)

As process area leader: Developed an already-good Department into a company-recognized Center of Excellence

Led Lean Six Sigma process re-engineering of CMO’s supply chain

Enhanced the CMO’s systems, staffing and skilling to ensure full-cycle, supply-chain productivity

As project manager: Collaborated with global partners to create a harmonized, aligned Quality Management System

Negotiated Quality trade-off decisions across the global supply-chain network

Result: Fulfilled commitments to FDA and HC to align and harmonize company’s Quality Systems

Quality Compliance

As consultant: Evaluated CMO and its suppliers’ Quality compliance with

previous Agreements and current Regulatory requirements and commitments

Collaborated with Line Managers, SMEs and CMO stakeholders

Result: Established employee curricula

Authored Documentation and Training Quality Management Systems

Communicated Quality duties by training, coaching and mentoring client’s personnel

As project manager: Ensured the supply chain’s data-based Quality performance, reliability and integrity

Collaborated with CMO matrix teams to develop, implement and support Key Performance Metrics

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Knowledge Barrier: overcome by complete, compliant, accurate Documentation and Training Systems

As MBA student: Learned the necessity of effective, efficient baton passing of information at each Moment of Truth

As process area leader: Led product, process and equipment transfers for transferring and receiving organizations

(Site-to-Site transfers and Bench-to-Commercial scale ups)

Participated in the negotiation and oversight of Business and Quality Agreements

As project manager: Led a 15-person matrix team during supply-chain, value-stream analyses

Presented capability supply-chain assessments and productivity recommendations to management

Result: Minimized potential gaps, duplications, delays, frictions, erosions, decays and destructions

at each information-handoff

Result: Company culture began to transition from adversarial to collegial

Knowledge Management: enabled by Site Readiness (Inspection and Audit Systems)

As auditor: Performed internal and CMO compliance audits (FDA Six-System Inspection Model)

Prepared and defended audit reports

Collaborated to improve adherence to both Quality Agreements and Regulatory Guidelines

As Site Quality Lead: Prepared 6 direct and 40 indirect reports for customer audits and Regulatory inspections

Hosted FDA, EMA and HC inspections

Result: Avoided significant Regulatory Observations and actions

As Plant Manager: Prepared 10 direct and 80 indirect reports for Pre-Approval Inspection (“PAI”)

Stabilized, remediated and improved Observed Quality issues

Result: FDA approved company’s NDA

As Operations resource: Front-room roles during Regulatory inspections

Result: Avoided significant Regulatory observations and actions

Customer-facing roles during audits (e.g. primary Quality and technical contact)

Result: Obtained contracts and Preferred Vendor status

Result: Created profitable, productive relationships

Result: Established mutual goals with customers and product and service providers

Knowledge Management: powered by Site Response (Deviation and Complaint Investigation Systems)

As consultant: Authored Event Management Quality System to ensure accurate and timely reporting of each observation

Included Complaint intake dialog, confidential recording of complainant information, triaging according to assessd severity, response and resolution notification

Result: FDA Inspector determined the System to be “Acceptable”

Initiated then led Lean Six Sigma process re-engineering of Investigation process

Authored Investigation Quality Management System to ensure robust search for Root Cause

Result: Improved the Investigation “closed within 25 day” metric from 15% to 70% in 6 months

Prepared responses to Health Authority 483 letters, Consent Decree-negotiated commitments

As Site Quality Lead: Single point of contact for FDA notifications:

Field Alerts, product recalls, retrievals, reconciliations and destructions

Created Top Gun Investigator program, then trained, coached and mentored those Investigators Result: Rigidity of Evaluation-Flexibility of Response Method enabled robust investigations

Developed cultural framework to effectively, efficiently identify Root Causes

Result: Created a Root Cause Analysis Form to enable more-accurate metrics and trend analyses

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Risk Management: aligned with Organizational Change (CAPA and Change Control Quality Systems)

As consultant: Led CMO matrix team to establish risk recognition/ risk mitigation/ risk quantitation systems

Authored CAPA Quality Management System to ensure compliance incidents were effectively addressed

Leveraged Risk Management principles to facilitate Strategic, Operational and Tactical decision-making

Result: FDA Inspector determined the system and the company’s adherence to it to be “Acceptable”

Result: Enhanced and standardized output, communications and terminology

(including Effectiveness Checks)

Result: Assessed/ ensured Investigation method compliance and effectiveness

Timely Root Cause analyses, identification, response

Accurate CAPA proposal adequacy/ compliance

CAPA closure timeliness and effectiveness

Result: Enabled/ facilitated Continuous Improvement and development of cultural shared purposes

Collaborated to create a Change Control System that closed information loops

Recognized direct and indirect resistance to proposed organizational change and addressed each cause

Aligned the System with national and regional Regulatory Guidances

Harmonized the System across the company’s operating sites

Result: Company demonstrated effectiveness of implemented System to both customers and regulators

Result: Company maintained uninterrupted global supply chain processes

(from API suppliers to Third Parties, distributors and patients)

Result: Company fulfilled Consent Decree commitments on time (i.e. without incurring penalties)

Led supply-chain, value-stream, cross-functional team exercises

Result: Helped identify vulnerability of organization’s critical assets to specific threats (AS-IS)

Result: Facilitated decisions whether to avoid, mitigate, accept or offload risk and risk’s effects

Result: Defined and designed new processes with embedded risk control/ containment (TO-BE)

Objective: goal line

Scope: side lines

Rationale: competitive advantage

Evaluation: tools and methods

Controls: governance, oversight and timing

EDUCATION

Master of Business Administration Texas A&M University, TX

Focus Organizational Change Leadership

Risk Management

Operational Excellence

Project Management

GPA 3.9 ( Phi Kappa Phi Honor Society )

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