Project Manager Quality

EVANS DITTMAN, MS (QARA), CQA (ASQ)

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

Hampton, NJ 08827

Home 908-***-**** ********@*******.***

A highly motivated, successful, and results-oriented professional, with

over 20 yrs in Life Sciences, recognized as a passionate expert in quality

and validation management. Superior collaboration and technical skills

facilitate quality process definition and improvement resulting in risk-

based quality outcomes. I specialize in delivering creative solutions,

quality by design, and right results first time while utilizing a rare

combination of Quality Assurance, Scientific, Analytical, Manufacturing,

and Information Technology expertise.

Certified Green Belt Creation, implementation, and improvement

Certified ASQ Quality Auditor 15 of Quality Systems, Policies, and

years, with over 100 audits performed. Procedures to ensure compliance with

regulatory, legal, and business

Certified PMI Project Manager requirements using Process Excellence and

Professional Lean methodologies for change control,

Audit program management including CAPA, deviations, non-conformance

scheduling, internal and external investigations, document control, and

auditing, pre-approval inspection product complaints.

audits, gap assessments, and Global process and control harmonization,

regulatory hosting. monitoring, and improvement.

Training development and delivery for In-depth knowledge of both domestic and

quality systems, validation, GxP, and global regulations (FDA, ICH, ISO, WHO,

auditing. EMEA, MHRA, TGA, DEA, SOX, etc.) with

Failure and non-conformance significant audit hosting experience.

investigations, including root-cause Applied knowledge of the application of

analysis and remediation management. Advanced Quality tools, such as Failure

Trend and risk analysis, process Modes Effect Analysis (FMEA), SPC, Root

analytics, statistical analysis, and Cause Analysis, Mistake

metric development. Proofing/Poka-Yoke/Value chain mapping.

Regulatory documentation creation, High performance team leadership and direct

reviews, and approvals (SOP's, report development.

specifications, annual reviews,

validation packages, design controls,

etc.).

PROFESSIONAL EXPERIENCE

The College Board Ewing, NJ 2010

Principal Quality Engineer

Drive decisions with external manufacturing partners relating to product

quality assurance and quality controls.

Facilitated and coached the implementation of vendor quality system,

including the establishment of maturity evaluation and rating, and the

reporting to executive management through review of Right-First-Time, CAPA

effectiveness, change control, and other measures.

Identification and implementation of continuous improvement initiatives.

Oversee nonconformance investigations, complaint investigations, supply

chain disruptions, qualification and validation.

Define, approve, and enable the implementation of quality requirements,

quality plans, and quality check points to ensure adequacy of controls and

resulting outputs.

Partner with vendors to implement advanced quality tools such as control

plans, statistical process control, statistical sampling and analysis, risk

analysis, etc. to ensure processes are designed, deployed, and operated to

maximize quality and right first time results.

Celgene Inc. Summit, NJ - consulting 2009- 2010

Quality System Design

Partner with the different quality business areas (CAPA, Change Control,

Deviation, Complaint, Audit, and Supplier Management), IT, and project

teams to provide detailed guidance to define, improve, and automate

quality processes for a new Enterprise Quality and Regulatory Management

System.

Global process harmonization, incorporation of best practices, and delivery

of lean processes for change control, CAPA, non-conformance, and deviation

investigations.

Definition of business objectives, solution development, schedules and

priorities, and project management for implementations.

Translation of business requirements into detailed technical requirements

to facilitate compliance with the SDLC and validation process requirements.

Alpharma Inc. Bridgewater, NJ (acquired by King, position eliminated)

2007- 2009

Quality and Validation Manager

Responsible for transformation, management, and execution of quality

policies and procedures to best practice including the incorporation of

risk-based approaches for; SDLC and release management, Change management

(Chaired Change Advisory Board), CAPA, deviations, and non-conformance

investigations.

Responsible for implementation and management of the quality system,

including reporting of performance and maturity to executive management.

Head of the validation function in all business units including process

validation, facilities, manufacturing and laboratory equipment

qualification, global IT solutions, and infrastructure. Responsibilities

included; creation of Validation Master Plan, directing cross-functional

teams, approval/authorization of deliverables, gap and defect management,

performance monitoring, training, and representation of CSV to regulatory

bodies.

Chaired the Validation Steering Committee and Change Advisory Board.

Member of the Material Review Board.

Established and maintained Management Review for quality system

effectiveness.

Coordinated site training requirements, delivered GMP and technical

specific training, created and managed associated metrics.

Johnson & Johnson, Raritan, NJ (reorg - position eliminated) 2001- 2007

Quality Systems Manager

Responsible for providing strategic direction, development, and decision

making with respect to the design, implementation, and maintenance of

Global Quality Systems; including Change Management, CAPA, SDLC and CSV,

and the internal and vendor audit programs. These implementations

included development or modification of policies and procedures,

training, and monitoring of metrics.

Responsible for the management and effectiveness of the CAPA (Corrective

Action Preventative Action), Change Control, and document management

processes including: monitoring and improving the effectiveness of the

programs; coordination of approvals and investigations; data trending and

reporting; and communication with management, process leaders, and

auditing bodies.

Harmonized the various change control process into a global risk-based and

robust process that significantly reduced cycle-time, number of systems

(<600K annual cost reduction), and increased standardization.

Directed the creation of the internal audit group during the maturation of

the QA organization within IT, including all processes, procedures,

schedules, training, and metrics.

Designed and implemented a supplier qualification program.

Created an inspection readiness program for the business unit as a green

belt project. Earned DMADV Green Belt.

Proposed, developed and implemented a scalable and results focused approach

to define program requirements, controls, and testing for Sarbanes Oxley

compliance based on CobiT framework. Partnered with Corporate Internal

Audit to develop use across all of J&J. Received Standards of Leadership

award.

Designed and executed the Part 11 program prior to the introduction of GAMP

4 including presentation to the Board and key stakeholder franchises,

conducted and managed the gap analysis, development of all the tools to use

in retrospective qualification, and approval of program deliverables.

Received Standards of Leadership award.

Provide strategic consultation and coaching to the business including:

validation planning and execution; computer system and process assessments;

compliance and risk management, regulatory interpretation; benchmarking;

training; remediation planning and execution; and development and

implementation of quality plans, procedures and systems.

Managed both direct reports and consultants to ensure program goals are

exceeded. Several promoted.

CimQuest Inc., Systems Regulatory Compliance, Exton, PA 1998 - 2001

Quality/Validation Manager and Site Lead

Managed systems regulatory compliance consulting services at customer sites

including: quality system design and maturation; computer system

validation; Part 11 assessments and remediation; gap analysis;

development of suitable policies and procedures; supplier and internal

auditing; staffing and budget; and customer training.

Designed and directed the successful implementation of a quality system for

a research organization that migrated to a GxP supplier resulting in an

audit by the FDA with no 483 observations related to my work. Conducted gap

analysis and created gap closure plan.

Developed training program, assessment and remediation planning processes,

and presentation for Electronic Signatures/Records rule (21 CFR Part 11)

for both internal and external customers.

Designed and implemented a supplier qualification program.

Managed performance and development of direct reports to ensure achievement

of organizational and department by providing an environment that

encourages ongoing personal and professional growth.

IBAH Pharmaceutics Services, Fort Washington, PA 1994 - 1998

Analytical R&D - Group Leader, Quality Assurance, and validation manager

Responsible for failure and non-conformance investigations delivered root-

cause analysis resulting in over $5M savings.

Established and maintained the stability and retained sample management

programs.

Led technology transfers to CMO and scale-ups for commercial production.

Site-wide validation manager for process and systems, analytical methods,

and design of the cleaning validation program.

Regulatory submissions including: CMC sections, analytical and process

validations, and annual reviews/reports.

Conducted numerous supplier audits, and hosted customer and regulatory

audits.

Reviewed and approved cGMP documents for site, including master batch

records, SOP's, specifications, validation deliverables, deviations,

protocols, reports, technical memos and change controls.

Administration of laboratory systems and LIMS.

Johnson Matthey, Biomedical Products Group, West Deptford, NJ 1991 - 1994

Analytical R&D Group Leader & Laboratory QA

Methods development and validation for analytical R & D.

Managed all qualification and validation activities related to 100,000 sq.

ft. facility expansion.

Provided QA and release of raw materials, in-process, and final product.

Designed and implemented quality systems for analytical laboratories in

preparation for ISO certification. Resulted in first pass ISO

certification.

Regulatory submission preparation including: CMC sections of several DMF's

and DEA reports.

Administration of laboratory systems and LIMS.

Various contract positions as Analytical Chemist w/Merck, J&J, Hoffman

LaRoche 1987-1991

Product analysis, validation, investigations, product compliant

analysis, and other technical services.

TECHNOLOGY: Brief Listing - Extensive and diverse computer expertise

including Document Management Systems (Documentum, Qumas),

Quality Systems (EtQ, TrackWise, Pilgrim, Rationale), Data

Acquisition Systems, Laboratory Information Management

Systems (LabWare, StarLIMS, HP), MES & ERP systems (SAP,

JDE), programming (Fortran, APL, Pascal, C++, UNIX, Java,

ladder logic, and some Basic), DCS (Siemens, DeltaV, Allen-

Bradley, GE Faunce), SAS, Sharepoint, eRoom, MS Office

products, PE tools (minitab), and network operations.

EDUCATION: MS Quality Assurance and Regulatory Affairs, 3.98/4.0, Temple

University - 1999

B.A. pre-professional Biology, Summa Cum-Laude, Kean College, Union,

NJ - 1984

Certified Six Sigma Green Belt, Johnson & Johnson - 2006

Certified Quality Auditor, American Society of Quality -1994

Certified PMI Project Manager Professional - 2002

AWARDS: Standards of Leadership - 2002, 2005

Crown of Excellence, Significant Accomplishment - 2001

First Platinum Encore Award ever given - 2005

Inaugural Employee Achievement Award - 1999

PRESENTATIONS & PUBLICATIONS : 1999 PDA Spring Conference - Electronic

Records and Signatures an Overview and Guidance

E-Signature Rule, 21 CFR Part 11, Overview and Guidance,

Pharmaceutical Manufacturing and Packaging Services,

September, 1999

MEMBERSHIPS: Assistant Scoutmaster Troop 200 and Eagle Scout

Alternate on the PDA Part 11 task force

American Society of Quality, American Chemical Society, Parenteral

Drug Association, and American Association of

Pharmaceutical Scientists, MARSQA, Tri-Beta Honors

Society

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