Nasrat Hakim

** ****** **.

Hillsborough, NJ ****4

908-***-**** (H)

201-***-**** (C)

email: hp88ni@r.postjobfree.com

Profile

Twenty years of pharmaceutical and medical industry experience in Quality Assurance, Quality Control, AR&D and Regulatory Compliance.

Educational discipline in Law (JD/LLM), Business, Regulatory Affairs (RAC) and Chemistry/Bio-Chemistry (MS).

Proven management experience establishing new departments, building cross-functional teams, creating sustainable GxP-compliant programs and preparing domestic and international sites for successful FDA/regulatory inspections.

Extensive quality experience designing and implementing Corporate Quality Systems impacting multiple sites, and managing internal and external compliance oversight and risk assessment.

In-depth technical knowledge of quality and manufacturing systems and technologies including immediate and extended release formulations used in solid dosage, transdermals, (Medical Device) insert and implant finished products.

Solid regulatory command of GMP’s, national and International regulations. Ability to research, analyze and implement systems to comply with global regulations in support of timely and successful new product applications.

Successful change agent via creation and implementation of global compliance program and remediation of existing programs and systems across multiple sites.

Experience

2007-Present Mikah Pharma Consulting, Hillsborough, NJ

Consultant to the CEO, Quality & Compliance EPIC Pharma, Laureltone, NY

Consultant /Vice President of Quality Alexza Pharmaceuticals, Palo Alto, CA

Setup GMP, GLP & GCP Quality Systems for Alexza’s Medical Device facility “Staccato Inhalation Technology”.

2004-2007 Alpharma (Actavis), Inc., Piscataway, NJ

Corporate Vice President of Quality and Compliance (Actavis U.S. sites)

Direct responsibility for the Quality Unit (QA, QC and Regulatory Compliance for Manufacturing and R&D), Corporate Compliance, Technical Services and Global Computer Compliance. Five manufacturing facilities, two R&D sites and numerous contract manufacturers producing 200+ finished products.

Responsible for GMP, GLP, GCP systems, auditing regulatory application, CRO’s and clinical sites.

Manage departmental budget of $50 Million and 450 employees.

Executive Committee member reporting to the president.

Corporate liaison to FDA.

Global Vice President, Compliance (Alpharma)

Head of Global Compliance for Alpharma’s four Business Divisions (Brand Human Pharmaceuticals, Generic Human Pharmaceuticals, Active Pharmaceutical Ingredients and Animal Health.), twelve sites and corporate departments.

Executive Team member reporting to the President, and Board of Directors.

Responsibilities included:

Creation of a Global Compliance organization to support Alpharma facilities in the U.S., Europe, China, Indonesia and India. Created a professional department with experienced professionals from both industry and regulatory agencies.

Risk management via direct interaction and dialogue with the applicable regulatory agencies.

Risk assessment of approximately 1350 raw material vendors, contract manufacturers and contract service organizations via the establishment and maintenance of an external audit program.

Created and Chaired the Global Compliance Council.

1997-2004 Watson Pharmaceutical (TheraTech), Salt Lake City, UT

Executive Director, Corporate Compliance and Technical Projects

Transitioned, post-acquisition of TheraTech, from site to corporate responsibility.

Responsible for compliance assessment of 12 Watson sites, 31 contract manufacturers and 460 suppliers.

Created a Corporate Compliance Department with appropriate systems to:

Ensure successful creation and implementation of corporate policies.

Perform internal site assessments and support remediation for cGMP compliance with FDA and other regulatory agency requirements.

Conduct mock PAIs and review of IND, NDA and ANDAs.

Monitor compliance of contract manufacturers, contract laboratories, suppliers and service providers with applicable policies/regulations.

Benchmark best practices at each site and relay the knowledge and solutions to other sites.

Serve as consultant and “trouble shooting” support for the various Watson sites.

Chair several committees including Quality Improvement Program (QIP).

Set-up corporate control systems such as LIMS (Laboratory Information Management System).

Evaluate site procedures and design appropriate systems to elevate the quality practices to an acceptable level (e.g. training, change control, validation, SOPs, etc.)

TheraTech, Inc. (acquired by Watson), Salt Lake City, UT

Executive Director, Site Head of Quality and Compliance

Report to CEO. Responsible for all aspects of Quality Assurance, Quality Control and Compliance for the Commercial Manufacturing and R&D Transdermal facilities.

Developed and implemented Quality Systems for manufacturing and research and development at TheraTech, Inc. from company start-up through commercial operations.

Assisted and advised other departments (Manufacturing, Regulatory Affairs, AR&D, Product Development and Clinical) in preparing and executing development and validation documents.

Reviewed technical problems and procedures and recommended solutions.

Interfaced with and hosted FDA and client audits.

1988-1997 ALZA Corporation, Palo Alto, CA

Senior Manager (Scientist), Analytical Research and Development

Manager, Quality Control. Vacaville facility.

Extensive experience in QA, manufacturing and testing of ALZA’s time release technology (OROS Tablets, Transdermal patches, Inserts and Implants.)

1985-1988 Department of Food and Agriculture, Sacramento, CA

1982-1985 Medical Laboratory Technologist, Angwin, CA

Education

St. Thomas University, School of Law, Miami, FL

Masters of Law (LLM)

California State University at Sacramento, Sacramento, CA

Masters of Science in Chemistry

Bachelor in Chemistry/Bio-Chemistry

California State University at San Diego, San Diego, CA

Graduate Certification in Regulatory Affairs (RAC)

Golden Gate University, Sacramento, CA

MBA Courses

Academy of Health and Sciences, U.S. Army, San Antonio, TX

Medical Laboratory Technology

References

Available upon request.

Contact this candidate