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Quality Training

Bedminster, NJ
December 11, 2019

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Karl Kovacs

* **** **** ****

Bedminster, NJ ****1

FDA-Qualified Global Leader: CGxP Quality Systems

Delivers cost-effective CGxP results to enable compliant, effective, efficient productivity


Crowne Pharmaceutical 6/ 2008 – Present

Global Leader, CGxP Quality Systems

(Documentation, Training, Deviation Management, Investigation, CAPA & Change Management)


Investigation/ CAPA/ Training

Risk Management (MBA)

Change Management

Project Management (MBA)

Quality Systems Development

Technical Writing (SOP, CMC)

Operational Excellence (MBA)

Six Sigma (Green Belt level)

Technology Transfer Leadership


CGxP Quality Systems Mindset

Analyzes, designs, develops, implements and evaluates Quality Systems to quantitate practical benefit, cost and risk

Ready and willing to learn, coach and mentor by getting hands on the wrench and boots in the trench

Leads by example, influence, persuasion, and negotiation to decide based on shared, participatory consensus

Exhibits a genuine commitment to each person’s success

Communicates that Quality and Management are each person’s responsibility

Enables complex concepts and issues to be easily understood

Result: Increased opportunities to develop credibility, build trust and enable collaboration in both Board rooms and Stock rooms

CGxP Quality Systems Skillsets


Lead multi-functional, value-stream mapping exercises to identify Quality System compliance and performance gaps (As-Is)

Lead multi-functional brainstorming sessions to reach consensus on effective, efficient Corporate/ Departmental (To-Be) process

Karl Kovacs

Quality Systems Program Management (as Site Quality Leader)

Lead cultural/ regulatory transformation of acquired $70 MM pharmaceutical division

Create Quality Center of Excellence to coach and mentor personnel (especially Training and Investigation teams)

Mentor Senior Management and Quality Review Board members to create a quality culture

Create Clinical and Commercial Complaint intake and processing program

Result: Positive regulatory compliance results were confirmed during a subsequent FDA inspection

Decreased batch documentation review period by 50% / Reject rates decreased to ~0%

Create/ revise/ review/ approve Analytical Methods, SOPs, Master Batch Records, Quality Agreements

Result: Decreased reject rates from 3% to ~0%

Global Quality Systems Project and Program Management

Integrated an acquired virtual company’s Quality Management Systems for $7 BB Tier 1 company

Manage the eight (8) QA, QC, IT, site integration, and site closure Workstream projects

Prepare the multi-site, multi-country, multi-function MS Project 2010® documents

Lead a cross-functional, ~20 person project team to create, align and harmonize 7 Corporate Quality Systems

Result: Company maintained uninterrupted global supply chain processes (from API to Third Parties, distributors and patients)

Result: Fulfilled all cutover commitments without incurring any financial penalty

Co-ordinated Quality Systems deliverables for $8 BB global joint venture

Collaborate to enable benefits realization for eleven (11) Quality Systems milestones

Design project status dashboards to communicate change readiness metrics to senior team

Participate in developing and reviewing Quality Agreements

Result: Fulfilled all cutover commitments without incurring any financial penalty

Lead a global CRO’s multi-site CGxP Quality Systems re-engineering

Lead a 30-person, cross-functional team to re-engineer, align and harmonize company’s 8 Global Quality Systems

Lead multi-functional team in brown-paper exercise to identify As-Is and To-Be gaps/ roadmap

Negotiate trade-off decisions across a global network to fulfill commitments and ensure shared data integrity

Harmonize the Quality Management Systems across the company’s operating sites

Train each Team to perform (As-is and To-be) brown-paper, capability-gap assessments

Result: Company de-chartered the progam due to internal political, functional and cultural resistance to change


Support the transition from paper-based to electronic systems (e.g. Documentum®)

Lead cross-functional brown-paper exercises to identify Documentation System compliance and performance gaps (As-Is)

Lead cross-functional brainstorming sessions to reach concensus on effective, efficient Corporate/ Departmental (To-Be)

Harmonize the Documentation Quality Management System across the company’s global operating sites

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

Lead an eight-consultant team to identify and implement Documentation Quality System best practice

Result: Increased the documentation compliance and cost-effectiveness

Develop a cost-effective, compliant Batch Record Certification checklist/ program to enable Third-Party batch release

Result: Decreased batching documentation nonconformance metric from more than 8 to less than 2 per batch

Karl Kovacs

Create the Documentation Quality System initiative, then lead the consultant team

Develop user-friendly compliant SOP and Master Batch Record repository and prototypes

Result: Standardized content, format and monitoring

Result: Improved the 21 CFR 820 and ISO 13485 compliance profile

Result: Decreased Documentation Quality System administrative costs by 50%

Result: Decreased Training Quality System administrative costs by 20%

Result: Decreased Investigation Quality System costs by 30%


Create Train-The-Trainer PowerPoint® presentations (including post-session Assessments)

Deliver Train-The-Trainer training to certify 800 employees

Coach and mentor Trainers

Result: Decreased major and minor investigations up to 25%

Nonconformance/ Event Management (e.g. from recognition/ observation through response stages)

Benchmark regulated/ non-regulated operating systems’ metrics (for solid, topical, and molded products).

Implement SPC to track and trend the quality and efficiency of Manufacturing and Laboratory operations.

Result: Increased productivity/ profitability by timely and compliant red-lining of potentially-impacted product


Initiate then manage the re-engineering of Tier 1 Third-Party company’s Investigation process

Create new investigation process’ SOPs and Forms

Train, coach and mentor Investigators to standardize compliant, timely investigation processes

Create, implement and administer TopGun Investigator qualification program

Coach and mentor Top Gun investigators

Lead multi-functional project team to develop a Root Cause/ Causal Analysis Chart

Lead and perform Investigations, then prepare/ defend Investigation Reports

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

Result: Partnered with Investigators to develop an Investigation knowledge management database

Collaborated to create a Root Cause Causal Analysis to enable more accurate trend analyses


Create TrackWise®-based CAPA Quality System for virtual company

Transfer virtual company’s new CAPA Quality System, then partner with Third Party to faciliatate implementation

Establish risk recognition/ risk mitigation/ risk quantitation systems

Result: Enhanced and standardized output, communications and terminology (including Effectiveness Checks)

Lead CAPA Review Board

Result: Assessed/ ensured –

investigation method compliance,

Root Cause analyses, identification

CAPA proposal adequacy/ compliance, and

CAPA closure effectiveness

Karl Kovacs

Lead transition of operations from reactive mode (CA) to proactive mode (PA)

Collaborate to deliver/ leverage multi-site knowledge management (i.e. Investigations) and risk management (i.e. CAPA)

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

Change Control

Create Quality System that closed information loops and tracked/ trended Effectiveness

Collaborate to create a Change Control Quality System

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

Harmonize the Change Management Quality Management System across the company’s operating sites

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

Quality Systems Program Management (as Plant Manager)

Design, equip, staff, commision, qualify and then manage a new pharmaceutical/ OTC/ nutritional Focused Factory

RESULT: Maintained the project’s $multi-million budget constaints and aggressive schedule targets

Lead up to 10 direct and 80 indirect employees to recognize that quality and management were each person’s responsibility

Create a cost-effective Suggestion Program

RESULT: Decreased batch documentation review period by ~50% (largely from implemented employee suggestions)

RESULT: Began to embed a sustainable, Continuous Improvement, quality-centric culture

Source Equipment and Identify Technology to cost effectively increase productivity and profitability

RESULT: Increased equipment uptime by 20%

RESULT: Increased fill material manfacturing equipment operating efficiency up to 40%

RESULT: Increased yields up to 10%

RESULT: Decreased scrap up to 15%

RESULT: Increased operating unit profits by $450,000 per annum

Design and build special applications emulsion production equipment

RESULT: Two $multi-million contracts were renewed and expanded


Create and then lead a 15-person, multi-functional team in the Lean Six Sigma re-engineering of a

mission-critial product type’s supply chain (order placement through customer support)

Lead multi-functional team in brown-paper exercise to identify As-Is to To-Be gaps/ roadmap

Result: Decreased full-cycle process time by 50% within 3 months of implementation

Karl Kovacs


Perform customer audits for branded companies then prepare/ present capability gap assessment reports

Front-room Regulatory roles during inspections

(e.g. hosted FDA inspections)

(e.g. co-ordinated product recall for Class III medical device)

Customer-facing roles during audits

Result: Created profitable partnerships, and established mutual goals with vendor service and product providers

Prepare sites for, and then host audits and inspections (including PAIs) of manufacturing and laboratory areas

Participate in the negotiation of the multi-site, multi-country Third-Party technical agreements

Result: Obtained contracts and Preferred Vendor status… avoided significant observations


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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