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Confidential Resue of JODY M. HUSSEINI EMAIL: jh6c7b92@westpost.

Highly experienced Quality Assurance/Regulatory Compliance professional with bro
ad knowledge of pharmaceuticals, class II/III medical devices, dietary supplemen
ts, and consumer products. Experience includes dosage forms such as soft gels,
tablets, liquids, semi-solids, ointments, creams, and vaccines. Compliance exp
erience includes FDA GMPs (110/211/820) and part 11; Consent Decree Management;
ISO9000; ISO13485; DEA; HACCP.
Technical skills include microbiology laboratory management; R&D QA; manufacturi
ng QA; CMC management; global license conformance; technical transfer and new pr
oduct launch; equipment qualification and process validation; batch record audit
and product release; internal and supplier auditing; GMP documentation; change
control; annual product reviews; problem solving and root cause analysis; CAPA m
anagement; product quality complaints and failure investigations; SOP developmen
t; cGMP training; electronic document systems such as Master Control; consent de
cree remediation; FDA communication and negotiation; corrective action plan deve
lopment, tracking and closure. Strong leadership, mentoring and soft skills.

Amerigen Pharmaceuticals, Inc., East Brunswick, NJ 5/2009-
Technical Consultant
Technical consultant for multinational pharmaceutical company with manufacturing
facilities in China. Provided support for the Quality organization by developin
g procedures and validation protocols, conducting supplier audits, training the
microbiology staff in technical matters such as microbiology test methods, ident
ification of microorganisms, environmental monitoring program, cleaning validati
on, equipment selection and qualification, investigations and corrective actions
, laboratory design, etc. Contract was completed.
Automation and Validation Solutions, Blue Bell, PA 5/2008-9/
Managing Consultant on site at Merck
Project Manager to manage qualification of numerous controlled temperature unit
and mentor bio-sterile validation department head and organization in process va
lidation, quality systems and cGMP concepts; tracked and reported site project p
rogresso executives, coordinated progress toward goals, worked with the client t
o assure goals were met on a timely basis, provided staffing recommendations, an
d managed staff. Contract was completed.
Strides, Inc., Somerset, NJ 11/2005-12/2007
Director, Quality Assurance
Site head of Quality Assurance for this start-up US subsidiary of Indian based S
trides Arcolab. Provided the technical expertise, Quality Assurance leadership
and GMP Quality System know-how for the company's transition from a nutritional
product base to a generic drug product base. Directed and mentored a team consi
sting of one Assistant Director, three managers, three line inspectors, and vari
ous independent contractors in management of Quality Operations, Quality Systems
, Product Release, manufacturing and laboratory compliance, FDA inspections, cor
respondence and remedial actions. The company developed financial issues and wa
s sold.

Quantum Resources, Inc., Richmond, VA 12/2004-11/2005

Program Director
On-site contractor reporting to the VP of WW Quality Assurance in Scientific Aff
airs for a large pharmaceutical client. I acted as the project manager for a co
mplex global regulatory compliance program involving North American export regul
ations and global affiliate license conformance. Developed master plan to implem
ent a product based change control system for North American manufacturing facil
ities and global affiliates. Also mentored staff and traveled to sites to train
local management. Contract was completed.

P F Laboratories, Inc., Totowa, NJ 11/2002 - 7/2004

Associate Director, Quality Assurance
Led a team of permanent, temporary staff and groups of consultants for this manu
facturer of OxyContin* and OTC drug products. Goal was rapid compliance remediat
ion. Managed Validation, Change Control, Annual Product Review, Product Complain
t, and CAPA systems.
* Mentored and developed staff, conducted performance appraisals, and maintained
motivation during high stress period in the company history.
* Eliminated a backlog of over 400 product complaints, and established a more ef
ficient complaint system.
* Eliminated a backlog in the Annual Product Reviews and reduced cycle time for
* Provided QA design input for an automated CAPA program within an SAP environme
* Established metrics used to monitor and measure quality system and group perfo
* Conducted complex high profile failure investigations resulting in root cause
Patent litigation on key product led to severe company downsizing and facility c
Carter-Wallace, Inc., Cranbury, NJ and Richmond, VA 1996 - 2
Manager, Corporate Compliance, Training and ISO Support 2001 - 2002
Compliance Manager 1996 - 2001
Compliance Manager for Class II and III medical device manufacturing facility.
Managed all FDA activities at plant level and maintained excellent FDA complianc
e profile; implemented QSR and ISO13485 systems such as Design Control, Risk Ana
lysis, CAPA, Management Review, Nonconformance System, Product Complaints, Chang
e Control and Validation; developed SOPs and training programs; acted as Managem
ent Representative and Chair of the Quality Review Board; audited Quality System
and managed remedial action plans. . Promoted to a corporate management role a
t corporate level for this manufacturer of Astelin*, Felbatol*, Soma*, Trojan* C
ondoms, and other Rx/OTC drugs.
Senior Manager, Quality Assurance
1994 - 1996
Supervisor, Quality Documentation 1990 - 1994
Managed 15 salaried employees consisting of the Quality Engineering and Quality
Assurance units supporting the Consumer Health Products Group, Parke-Davis and W
arner-Chilcott divisions. The facility manufactured a broad range of brands incl
uding Lipitor*, Zantac*, Benadryl*, Lubriderm*, Listerine*, EPT*, and generic dr
ugs. Managed a $1 million operational budget and core Quality Assurance functio
ns. Interfaced heavily with FDA as a key coordinator during the 1993 FDA Consen
t Decree. Developed product certifications resulting in immediate return to manu
facturing status; developed Remedial Action Plans for the prescription Zarontin
Syrup and Zarontin Capsule products; streamlined the product release function to
shorten cycle time. Reviewed and approved documents such as SOPs, failure Inves
tigations, product complaint investigations, annual product reviews, and validat
ions. Managed the batch record audit and product release function.
UDL LABORATORIES, INC., Largo, FL 1986 - 1990
Microbiology/Regulatory Affairs Manager 1987 - 1990
Microbiology Supervisor 1986 - 1987
Managed and remediated the microbiology laboratory; submitted ANDAs for unit dos
e generic company. Traveled to OGD for meetings with FDA to resolve issues.
R.P. SCHERER CORPORATION, Clearwater, FL 1983 - 1986
Associate Microbiologist
Conducted microbiological analysis of raw materials, water, soft gel products an
d manufacturing environment.


BS, Microbiology, University of Alabama, Tuscaloosa, AL
ASQ Senior Member
Regulatory Certified Profession by RAPS (former)
Registered Microbiologist (RM), American Academy of Microbiologists
Kepner-Tregoe Certified Program Leader in Problem Solving/Decision Making for Wa
BSI ISO 9000 Lead Assessor Certification Course for Medical Devices and Healthca
re Products