Quality Assurance Manager

Confidential - Professional Profile

Zahra Rashidbaigi

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

Basking Ridge, NJ 07920

(W) 845-***-**** (BB) 845-***-****

Career Profile

Quality and Compliance leader with a broad spectrum of knowledge in

research/ development, manufacturing, analytical, stability, quality and

compliance (GxP). Highly motivated, effective communicator and result-

oriented individual. Process and operational excellence driven, decisive

leader who transforms the group dynamic to a positive domain. Proven

capabilities to effectively partner, collaborate and network cross

functionally and culturally to achieve organizational goals and objectives.

Excellent analytical and investigational ability.

Core Competencies

. Quality and compliance

. Regulatory Audit/PAI

. Research and Devlopment

. Risk Management

. Change Management

. Complaint and Investigation

. Customer focus

. Managing colleagues and budget

Key Accomplishments

. Design and implement science and risk based quality system for New

Product and Process Development global network.

. Leading efforts to design Quality Risk Management training module

for Development.

. Led consent decree verification and annual audit for Vaccine

Development Quality Operations (no observation)

. Re-engineered, optimized and harmonized Vaccine Development Quality

Systems

. Streamlined Vaccine Development complaint handling process

. Established Quality teams/systems, material review board for

Schering Plough Development Operation.

. Managed NDA reviews, data audit and PAIs for several products

(Lipitor, Zetia, Gabapentin, Rezulin, Omnicef, FemHRT and Cerebyx).

. Recipient of several awards including Impact Award, Outstanding

Performance Award, Team of the Year, Above and Beyond, Best of

Everything, Star, and several patents.

Work Experience

Pfizer Inc. (Legacy Wyeth), Pearl River, New York 10965

New Product and Process Devlopment Quality Leader (Sr. Director, US and

Puerto Rico)

February 2008- Present

. Provide Quality and Compliance leadership to New Product and

Process Devlopment (NPPD) operations. Establish NPPD Quality

strategy and governance. Lead activities including coordinating

resources, defining and implementing of science and risk based

quality systems aligned with site, corporate and regulatory quality

guidance.

. Established Quality/Regulatory Council to monitor and track

quality/regulatory performance.

. Led streamlining instrument /equipment qualification process.

. Led integration and alignment of Chemical and Pharmaceutical

Development and NPPD Quality systems such as specifications and

analytical method development and transfer.

. Review and approve technical and quality documents (SOPs, test

methods, specifications, protocols, validation reports and batch

records), Quality Agreements assuring efficient and timely

resolution of product and compliance issues.

. Lead development of a Quality Risk Management training module for

Wyeth Development functional groups.

. Review and approve investigations and CAPAs.

Associate Director, Quality Assurance - Operations

March 2004- February 2008

. Directed Quality Assurance Operation and provided leadership for

tasks required for disposition of clinical trail materials

manufactured for human studies supporting regulatory submissions.

The scope also included contract and/or co-manufactured/tested

products intended for domestic and international clinical studies.

. Improved relationship and communication across functional groups

and Quality.

. Sponsored and led cross-site/cross functional harmonization and

optimization of quality systems and procedures.

. Ensured on-time availability of clinical supplies globally to

support new and on-going critical projects.

. Managed verification of consent decree action items and annual

audits (no observation).

. Collaborated closely with Clinical group to enhance compliance at

the Clinical sites.

. Directed documentation, investigations, and complaint/CAPA systems.

Schering-Plough/Merck, Kenilworth, New Jersey 07033

Manager, Compliance & Clinical Release

May 2001-March 2004

. Re-engineered the Quality unit's roles and responsibilities.

Established independent Quality Unit for Development Operation.

Hired 15 skilled and qualified staff to manage the department

workload and supervised personnel performance objectives and career

goals.

. Provided Quality Assurance direction and leadership in disposition

of all components, active pharmaceutical ingredients, drug product

containers and closures, in-process materials, packaging components

and finished drug products for use in clinical studies.

Established systems/groups to achieve this objective.

. Provided team leadership for several Quality System Programs and

GMP Work- Plan.

. Directed Zetia data audit and verification including training.

Successfully managed Zetia Pre-Approval Inspection for Development

Operation.

. Directed the investigation of deviations and technical product

complaint systems. Reviewed and approved investigation protocols

and reports. Managed GMP tracking systems.

Warner-Lambert/ Parke-Davis/Pfizer, Morris Plains, NJ, 07950

Manager, Quality Assurance, Consumer Health Care Research and Development

July 1999-May 2001

. Developed CGMP Guidance for Consumer Clinical Supplies.

. Managed training programs and database.

. Managed internal/external assessments.

. Reviewed/approved analytical reports, batch records and change

controls.

. Managed deviations and investigations.

. Approved release for shipment of clinical supplies.

Sr. Scientist, Pharmaceutical Delivery Systems R&D Quality Assurance

December 1996- July 1999

. Planned and led review and audits of NDA (CMC section of drug

product) and raw data supporting regulatory submissions including

batch records (form various sites, scale up, NDA or clinical),

technical research reports and supportive/ analytical documentation

according to departmental and FDA guidelines.

. Established a strategy for Pre-Approval Inspection (PAI) that led

to several successful PAIs (Lipitor, Neurontin, Omnicef).

. Managed preparation and coordination of mock Pre-Approval

Inspection activities.

. Coordinated/assembled technical responses to PAI observations.

Scientist, Technical Development and Assessment/ Supervisor of Centralized

Raw Materials

November 1991-November 1996

. Performed pre-formulation studies of discovery molecules, developed

and validated analytical assay methods. Conducted physiochemical

characterization of solid dosage forms.

. Managed preparation of drug product CMC section of INDs and NDAs.

. Managed procurement, storage, and dispensing of raw materials used

in manufacturing of clinical and Investigational drug products.

Sr. Associate Scientist/Scientist, Pharmaceutics

September 1984-October 1991

. Performed pre-formulation studies including physicochemical

characterization utilizing techniques such as HPLC, DSC,

microscopic analysis, kinetics of conversion of the epimers in

various media and enhancing its stability through complexation.

. Developed novel drug delivery systems with emphasis on transdermal,

transbuccal, and anorectal dosage forms for various classes of

drugs.

Education

MS., Nutritional Sciences, Department of Nutrition, University of

Wisconsin, Madison, Wisconsin

Doctor of Pharmacy, University of Tehran, School of Pharmacy, Tehran

Publications

1. M. Mahjour, B. Mauser, Z. Rashidbaigi and M. B. Fawzi, "Effects of

Propylene Glycol Diesters of Caprylic and Capric Acids (Miglyol 840)

and Ethanol Binary Systems on In Vitro Skin Permeation of Drugs," Int.

J. Pharm., 95, 1993, 161-169.

2. M. Mahjour, B. Mauser, Z. Rashidbaigi and M. B. Fawzi, "Effect of Egg

Yolk Lecithins and Commercial Soybean Lecithins on In Vitro Skin

Permeation of Drugs," J. Controlled Release, Vol 14, 1990, 243-252

3. Poster presentation entitled "Miglyol oil 840:Alcohol Binary System

as Effective, Non-Irritating Skin Permeation Enhancers," M. Mahjour,

Z. Rashidbaigi and B. Mauser at the 17th International Symposium on

Controlled Release of Bioactive Material in Reno, July, 1990

4. IR 2198 "Transdermal Delivery of CI-979," M. Mahjour and Z.

Rashidbaigi, April 1990

5. IR 2162 "Multilayer Transdermal Device," Z. Rashidbaigi and M.

Mahjour, December 1989

6. Poster presentation entitled "Use of Commercial Egg Yolk Lecithins as

Skin Penetration Enhancers," B. Mauser, Z. Rashidbaigi and M. Mahjour

at the 16th International Symposium on Controlled Release of Bioactive

Material in Chicago, August, 1989

7. Poster presentation entitled "In Vitro Skin Penetration Enhancement

of Tazifylline," Z. Rashidbaigi and M. Mahjour, 16th International

Symposium on Controlled Release of Bioactive Material in Chicago,

August, 1989

8. Abstract entitled "Evaluation Of Hamster Cheek Pouch As A Model

Membrane" Z. Rashidbaigi and M. Mahjour presented in the 14th

International Symposium of Controlled Release Society in Toronto,

Canada, August 1987

Patents

1. U.S. Patent 5,019,395 - "Composition with Enhanced Penetration," M.

Mahjour, B. Mauser, Z. Rashidbaigi and E. Linn, May 28, 1991

2. U. S. Patent 4,857,313 - "Transdermal Drug Delivery Device

Comprising Copolymers of N-Morpholinoethyl Methacrylate and 2-

Hydroxyl Methacrylate," S. Song, Z. Rashidbaigi, R. Nesbitt, and M.

Fawzi, August 1989

3. U. S. Patent 4,814,173 - "Silicon Elastomer Transdermal Matrix

System," S. Song, Z. Rashidbaigi, S. Mehta, R. Nesbitt, and M. Fawzi,

March 21, 1989.

4. U.S. Patent 4,789,547 - "Transdermal Matrix System," S. Song, S.

Mehta, Z. Rashidbaigi, R. Nesbitt, and M. Fawzi, December 6, 1988

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