Quality Assurance Project Manager

Carol Ann Livesey

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

Hightstown, NJ. 08520

E-mail: *********@*******.*** H: (609) 426-

8714

C: 609-***-****

Career Objective:

As a Quality Assurance professional with more than 23 years of

pharmaceutical experience which includes a strong analytical and consent

decree remediation background, I am seeking an opportunity to further

develop and use my management skills in the areas of GxP compliance and

quality assurance.

Work Experience:

HH&P LLC, Lawrenceville, NJ

October 2009 - Present

Quality and Compliance Manager

HH&P LLC is a pharmaceutical manufacturer of more than 65 OTC name brand

equivalent and generic ANDA products. The product line includes nasal and

oral dose liquids, suspensions, tablets and powders. The organization also

provides contract manufacturing services. The company was purchased by the

Triad Group in 2009 to enhance their existing product line of predominantly

Type 1 medical devices. All products and services at the NJ facility are

to be transferred to the Hartland, Wisconsin facilty. This transitional

role, post acquisition of the firm, is designed to provide guidance with

regard to cGMP compliance, technology transfer and ultimately taking on the

executive role for Quality Assurance and Regulatory Affairs at the Hartland

facility.

. Senior level position with five direct reports in Quality Assurance and

the Quality Control Laboratories in Lawrenceville, NJ

. Provide guidance and support to the quality and validation organizations

across both facilities

. Development of a robust Quality Organization, including hiring of key

staff members for the Hartland facility.

. Development and implementation of a Quality System based organization to

integrate the existing operations at both facilities into a single

compliant process

. Management of regulatory and customer audits

. Implementation and management of corrective actions related to internal

and external audits

. Management of positive client relationships related to contract

manufacturing operations

. Management of Customer Complaints and cGMP Training

. Management of Analytical Technology transfers as well as provision of

guidance for process transfers

Savient Pharmaceuticals, Inc., East Brunswick, NJ November 2007 -

September 2009

Quality Manager

Savient Pharmaceuticals is a small, virtual pharmaceutical company

preparing for a BLA submission with an injectable product that targets

chronic uncontrolled gout. As a virtual company, all research, analytical

testing, manufacturing and shipping and warehousing are outsourced to third

party vendors.

. Hired as a contract Manager in Quality Assurance with fulltime employment

contingent upon FDA approval of the BLA for KRYSTEXXA . This role

operates independently reporting to the Sr. Director of Quality Assurance

to assure the successful and timely implementation of key quality systems

in support of the companies key biological drug product KRYSTEXXA

. Development of quality systems

. Development and implementation of procedures for employee GxP training,

Deviation Investigations, CAPA, Biological Product Deviations and

Supplier and Vendor Qualification, Conduct of GMP Audits and Change

Control

. Manage the systems for Deviation Investigations and Corrective Actions

. Development and management of metrics for system assessment

. Provide mentoring and oversight of employees to ensure that newly

developed quality systems are maintained as appropriate

. Batch Record Review and Release

. Annual Product Review

. Supplier and Vendor Qualification program

. Review of analytical technology transfer protocols and transfer

activities to ensure successful transfer between two international

vendors

Palatin Technologies, Inc, Cranbury, NJ June 2005 -

September 2007

Senior Quality Assurance Specialist

Palatin Technologies is a small biotechnology firm with the goal of

identifying compounds with therapeutic potential for erectile dysfunction,

female sexual dysfunction and congestive heart failure, and to develop

those entities either through in-house development and marketing

partnerships.

. Managed the approval of a new third party manufacturer, the development

of the Master Batch Record, and performed Batch Record review for

clinical product release of a new sterile injectable for congestive heart

failure. Included in this work was quality review of all method transfer

reports and stability data. Management and active involvement in the

details of this project resulted in the successful submission of the IND,

meeting the company's timelines for the initiation of Phase I clinical

studies.

. Developed the Quality Standards Program as part of the implementation of

Key Quality Systems. Included in this program was a system for drafting

and approval of a Quality Standard based upon regulatory expectations and

industry benchmarks as well as a process for assessing gaps between

existing and newly approved Quality Standard.

. Implemented the system for Annual Product Review (templates and

questionnaires for acquisition of supporting data)

. Worked with the pharmaceutical Development Laboratories to create a set

of procedures that would provide structure and yet maintain the

flexibility needed in the GLP environment.

. Provided quality support (review and approval of protocols, reports and

review of data) for analytical technology transfers between the

development laboratory and selected vendors.

. Redeveloped the existing GMP New Hire Training program to include

awareness training for all new hires as well as an advanced training

specific to those individuals with GMP responsibilities.

. Conducted audits for the Supplier and Vendor Qualification Program

. Management of third party contractors and internal departments related to

deviations, change controls, CAPAs, document revisions, validation

projects and compliance issues

Schering-Plough Research Institute, Kenilworth, NJ September 1988 -

June 2005

Project Manager April 2005 - June

2005

. Worked with various teams composed of process owners and subject matter

experts to implement Worldwide Quality Standards as part of the Consent

Decree commitment to the FDA.

. Reviewed, evaluated and managed the gap analysis comparing the current

process to the Level II requirements for Materials and Sampling;

including chain of custody, disposition and storage. As a team leader for

a separate topic, I performed a gap analysis for Non-Product Contact

Surface Sanitization processes. The analysis included harmonization with

an existing process previously implemented in Quality Operations.

cGMP Workplan Teamleader - Laboratories September 2002 - April

2005

. Built and led cross-functional teams designed to re-mediate existing

quality systems (Microbiology and Technology Transfer) with the goals of

improved system efficiency and sustainable compliance.

. Management of twenty staff members in a matrix organization.

. Reviewed and evaluated current processes for the Technology Transfer and

Microbiology Quality Systems.

. Initiated the development and review of key operating procedures for

validation systems, technology transfer, qualification and administrative

systems by drafting SOPs and driving the documentation process through to

completion.

. Developed project plans to accurately define the scope of work and the

timelines to be met.

. Reviewed and compiled supporting documentation for evidence of project

and commitment completion. Packages were reviewed and audited by

internal and external auditing teams as well as subjected to FDA review.

All deadlines, as set by the FDA, were successfully met.

Technical Writer II September 2001 - September

2002

Prepared Quality Standard documents designed to provide globally harmonized

standards for development of improved quality systems for our fourteen FDA

regulated sites. Preparation included formatting the drafts, tracking the

responses, and ensuring that the standard champion has been apprised of all

replies to e-mails. Edited documents for content and consistency across

the quality standards. Used the Documentum system for document management.

Associate Scientist July 1991 - September

2001

Supported technology transfer to worldwide laboratory sites (training,

analyst qualification, method verification and troubleshooting).

Conducted physical and analytical testing of protein drug substances and

formulated product in support of stability, formulations, clinical

manufacturing and production.

Method development and method validation for small molecules as a service

request to other departments as requested for product quality review and

IND through NDA submissions.

Method development and method validation for the analysis of protein drug

substances and marketed products utilizing HPLC, GC, HPSEC, SDS-PAGE and

IEF in a GMP/GLP compliant laboratory setting.

Other techniques utilized in analysis included slot blot, Biacore probe,

IEF, RIA, and western blotting.

Wrote validation reports for regulatory submissions.

Assistant Scientist II September 1988-July

1991

Carried out physical and analytical testing of protein drug substances and

formulated products for purposes of identification, analysis of impurity

profile and quantification.

Method development for drug substances, formulated products and excipients

for those products.

The Graduate Hospital, Philadelphia, Pennsylvania June 1987 -

September 1988

Research Assistant

Conducted experiments for research projects involving serine protease

inhibitors and the effects of Aluminum on platelet activity.

Education:

Trenton State College, Hillwood Lakes, New Jersey

B.S. Biology 1986

B.A. Fine Arts 1984

Awards:

PalaTeam Award (September 2007) for management of tasks involved in meeting

IND submission timelines

Schering-Plough Excellence Award 1999 and 2000

Schering Plough Accomplishment Award 2002 for auditing projects.

Publications:

Identification, Characterization And Assay For A Variant of Recombinant

Human Granulocyte -Macrophage Colony Stimulating Factor (rhGM-CSF) Lacking

The First Sixteen Amino Acids.

J. Bausch, C.Livesey, S. Gruber, M. Pflumm, and S. Patel; Schering

Corporation, Kenilworth, New Jersey, USA

Presented at The Royal Society of Chemistry: Stability of Proteins/

Practice and Theory. March 1990

Light -Induced Denaturation of E. Coli - Derived Recombinant Human

Interleukin -10

M.N.Pflumm, C. Livesey, A. Paolino, S. Mercorelli, and J.N.Bausch; Schering-

Plough Research Institute, Kenilworth, NJ. 07033

Presented at The Thirteenth Symposium of The Protein Society, Boston.

August, 1999.

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