Site Head, Quality

Judith Estrada Zdanowicz

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

Dove Canyon, CA 92679

714-***-****

*******@*****.***

Background Summary:

Over twenty-three years Quality Assurance/Quality Control experience in

the pharmaceutical industry including pharmaceutical manufacturing of

solid dosage, small volume parenterals (oncolytics, anesthetics &

biologics); API manufacturing, medical device manufacturing, laboratory

management, batch record review/product release, technology transfer,

validation, regulatory inspections, supplier certification, vendor

auditing, quality control testing, and cGMP training

Proven Critical Competencies for Success:

. I have demonstrated the leadership ability to set plans and

objectives, model a strong results oriented approach, and I

consistently demonstrate the values of quality and customer

orientation. I am able to deal with complexity and I am a capable

and committed motivator and developer of talent and teams.

o Managed from the Quality perspective the entire facility

build-out of the Seal Beach IMF from Construction through

Validation.

o Hired the entire QA organization from start-up to Commercial

staffing.

. I have demonstrated the ability to develop trusted professional

relationships at all levels of the organization and have proven

results in working effectively with colleagues across different

functions by virtue of having a service mind set and by

understanding the needs of the organization. I am capable of

negotiating appropriately such that quality objectives are met,

compliance is ensured, and continuous quality improvement is

reinforced. I have the ability to relate well with individuals in

different cultural settings.

o Instilled a partnership attitude between Operations and

Quality to meet Quality Council Key Performance Indicators.

. I have demonstrated the ability to achieve results in a way that is

consistent with the business operations, and in support of business

objectives. I establish appropriate goals, communicate them

effectively, and achieve results. I understand the needs of the

business, the strategies, and the challenges inherent in

implementing a new strategy. I have proven my capability in leading

change and in instituting commitment to a culture of quality.

o Ensured employee goals for Quality team supported corporate

strategic goals down to the associate level with a 99%

completion rate. Goals were then tied directly to annual

reviews and bonus structure.

. I have the ability to consider the global picture, engage

effectively in a global organization, and have been an effective

team member of the global quality team, specifically related to

quality and facility assessments. I understand the implications of

local decisions in a broader and global setting, internally, with

clients, and relative to products.

o Project Sponsor for the implementation of multiple Project

Charters related to the enhancement of the QA Batch Record

Issuance program and Environmental Monitoring program.

Publication:

Birrer, G. A., S. Murthy, J. Estrada and J. Liu. "Parenteral Dosage Forms"

Chapter 7 of "Handbook of Modern Pharmaceutical Analysis" (S. Ahuja and S.

Scypinski, Eds.) Academic Press, Inc., pp. 269-304. 2001.

Work History:

April 2010 to Present

Dendreon Corp., Seal Beach Immunotherapy Manufacturing Facility

Sr. Director, Quality - Site Quality Head - Seal Beach and Union City

Immunotherapy Facilities September 2012 to Present

Sr. Director, Quality - Site Quality Head Seal Beach Immunotherapy

Facility, July 2011 - September 2012

Director, Quality - January 2011 to June 2011

Director, Quality Assurance - April 2010 to January 2011

. Site Head of Quality responsible for the complete quality organization

for two Immunotherapy Manufacturing facilities, Seal Beach, CA and Union

City, GA, consisting of 195+ Quality personnel with a budget of

approximately 40M.

. Directly manage five (5) Manager/Director level employees across two

sites from the following departments: Quality Control, Quality Assurance,

and Quality Engineering. Indirect oversight for Training, Validation and

EH&S at the sites as well.

. Provide leadership for all staff and ensure that the functional groups

are integrated into team atmosphere working toward common goals and

objectives.

. Ensure that all local and federal codes are upheld and complied with as

appropriate for the operations of the facility.

. Interface with the local government and business groups to ensure

Dendreon is the appropriate corporate citizen within the community.

. Develop, execute, and manage annual budgets utilizing the corporate

guidance and sales forecasts.

. Interpret and analyze statistical data and financial reports, understand

and resolve technical difficulties, interface with external customers in

an FDA/regulated manufacturing plant setting.

. Ensure that the appropriate compliance and operational metrics exist, are

trended, and communicated to executive leadership at corporate

headquarters.

. Collaborate with human resources and quality personnel to manage and

resolve personnel issues and GMP corrective actions as required.

. Collaborate with corporate peers and other general managers at other

plants to ensure that commercial production is comparable and consistent

between facilities.

. Create and maintain a culture and set of systems that are the standard of

excellence for Dendreon ACI production such that it becomes the basis and

role model for future facilities in other regions of the US.

May 1999 to April 2010

Teva Parenteral Medicines, Inc. (formerly Sicor Pharmaceuticals)

Sr. Director, Quality Assurance/Quality Control - Feb 2008 to April 2010

. Head of Quality responsible for the complete quality organization

consisting of 165+ personnel with a budget of approximately 22.5M

. Directly manage seven (7) director level employees from the following

departments: QC Chemistry, QC Microbiology, Quality Assurance/Quality

Systems, QA Project Management, International Quality Systems,

Documentation Control/Product Release, and Training.

. Responsible for the implementation and oversight of all quality

related functions such as regulatory inspections, compliance

activities, validation activities, raw material testing and release,

finished product and stability testing, CAPA initiatives, training,

documentation systems and final product release.

. Responsible for final product release of over 100 global products

manufactured from Teva and non-Teva sites

Director, Quality Systems and Training - March 2007 to January 2008

Associate Director, Quality Systems & Training - March 2006 to February

2007

Associate Director, QA Compliance, QA Engineering & Training - Sept. 2004

to March 2006

Associate Director, QA Compliance & Training - March 2004 to September 2004

Sr. Manager, QA Compliance & Training - September 2002 to March 2004

Sr. Manager, QA Compliance - March 2002 to September 2002

Manager, QA Compliance - May 1999 to March 2002

. Successfully interface with FDA (CDER & CBER), MCA, EMEA, Health

Canada and other regulatory agencies during PAI and general cGMP

Inspections; direct experience with QSIT (Systems Approach) Inspection

Process; Lead quality person in the inspection process.

. Manage inspection information and generate responses to regulatory

agencies. Communicate directly with Contract Customer Management the

results of FDA inspections and develop, in coordination with the

Customer, a mutually agreeable response

. Manage the QA department that handles the review and approval of

technical documents such as Critical System Change Requests,

Validation Protocols and Reports, Variance/OOS Investigations, and

Complaint Investigations to ensure quality/compliance issues are

adequately addressed and corrective actions are implemented

. Organized the change in the cleaning validation program philosophy to

include consideration of toxicity in addition to solubility

. Leader of Compliance Project Team with respect to Computer

Validation/Part 11 Compliance Remediation, Validation of Data

Acquisition Systems, and other compliance computer validation related

issues

. Develop and manage internal audit program consisting of facility

audits, product audits and spot-check audits. Ensure audit reports are

issued in a timely manner to all levels of management identifying

compliance issues and that the observations are addressed and

corrected by responsible management

. Assure compliance status of vendors by managing the external audit

program consisting of component vendors, API vendors, contract

manufacturers, and contract laboratories, which requires international

and domestic travel.

. Manage and direct the implementation of the Training Plan. Supervise

the training department activities as they impact employee

effectiveness and productivity, the reduction of variances/deviations,

the generation of special skill sets relating to

qualification/certification, and legally mandated cGMP training.

Maintain the training documentation software system.

. Verify implementation of corrective actions and compliance to

commitments from facility audits performed by regulatory agencies,

customers or through internal audits

. Coordinate and facilitate audits performed by Contract Customers

. Perform intra-company risk assessment audits of Teva facilities, and

provide assistance to intra-company facilities on compliance related

issues; assist with intra-company regulatory inspections

. Inform upper management of cGMP compliance trends by reviewing current

FDA-483s/Warning Letters issued to the Pharmaceutical industry and

through regulatory publications/journals, training seminars, internet

and industry membership

. Ensure Professional Services department operates effectively with

respect to handling of ADEs, customer complaints, and the medical

evaluation of ADEs

June 1998 to May 1999

Baxter Healthcare International, Baxter PPI, New Providence, NJ.

Manager of Quality, Contract Manufacturing

. QA Manager (Person-in-the Plant) for the manufacture of SVPs at four

contract manufacturing facilities located in Illinois, California,

Maryland, and Puerto Rico

. Reviewed and approved technical documents such as Validation

Protocols/Reports, Technology Transfer documentation, and Variance/OOS

Investigations.

. Generated Variance and OOS investigations as necessary.

. Reviewed Contract Manufactured drug product Batch Records, and

performed Product Release Authorization or Rejection Disposition

September 1996 to June 1998

Medeva PLC - MD Pharmaceuticals, Santa Ana, CA.

(facility scheduled to relocate to Rochester, NY)

Quality Assurance/Quality Control Manager

. Directly supervised three laboratory supervisors; entire department

consisted of twenty multi-level chemists and microbiologists

. Managed the Quality Control laboratories that handled all testing

including, API raw material and solid dosage raw material analysis,

finished API testing, in-process blend analysis, finished product

solid dosage testing, microbial testing and stability testing

. Handled the issuance and closure of non-conformance investigation and

Batch Record review (API and solid dosage)

. MD synthesized its own API and manufactured solid dosage (under DEA

Schedule II)

January 1991 to September 1996

Allergan, Inc., Irvine, CA. Allergan Medical Optics & Allergan Herbert Labs

Quality Assurance Laboratory Supervisor

Sr. QA Chemist

Chemist

Directly supervised six laboratory analysts in three distinct laboratory

locations

Supervised the QC laboratories that handled all testing including, raw

material analysis, finished product testing, in-process testing, complaint

analysis and stability testing

. Reviewed OTC and prescription product Batch Records, and performed

Product Release Authorization

. Set-up a new QC laboratory in Westport, Ireland used for the testing

of Vitrax ophthalmic solution; ordered equipment, validated

instrumentation, transferred analytical and microbiological methods

and trained laboratory personnel

May 1989 to January 1991

International Beauty Design, Inc. Gardena, CA.

R&D/QC Supervisor

. Directly supervised a lab consisting of four technicians

. Developed SOPs and a system for analyzing Raw materials and finished

products

. Developed new products for the nail care industry utilizing UV curing

polymer technology

May 1988 to December 1988

Baxter Healthcare, Hyland Division, Glendale, CA.

Quality Assurance Analyst

. Performed routine QC analyses: in-process, stability and finished

product testing for blood component products such as Factor VIII and

Factor X

Education:

University of Southern California, B.S. Chemistry, May 1988

University of Michigan, Ann Arbor, M.S. Pharmaceutical Eng., Anticipated

Graduation 5/2012

Software Programs:

ComplianceWire Training Learning Management System, Oracle ERP, First Doc

Electronic Document Management System, Microsoft Word, Microsoft Excel,

Microsoft Access, Microsoft Power Point, Microsoft Project, Microsoft

Outlook, Word Perfect, Lotus Notes, Lotus Organizer

Professional Affiliation:

Parenteral Drug Association

American Society for Training & Development

International Society for Pharmaceutical Engineering

References Available Upon Request[pic][pic][pic]

Contact this candidate