JANET NEELEY

PO Box 522
Black Hawk, CO 80422
(303) 582-6027
jn546714@westpost.net

DIRECTOR - QUALITY ASSURANCE

Policies & Procedures / Life Cycle--Development to Manufacturing / Aseptic / cGM
P / Biologics/ CMC Operations/ Supplier Quality Management / Training / Scale up
/ Inspections / Outsourcing / CTM
Specialize in supporting pharmaceutical operations while ensuring regulatory com
pliance in virtual or near-virtual environments. Provide QA leadership for start
up and Fortune 500 organizations in the biotechnical, pharmaceutical, and diagno
stic/device industries. Align R&D initiatives with operational goals, building s
ystems from the ground up to facilitate commercialization. Adapt practices to ma
ximize results with an economy of resources.
* Built QA systems for virtual company, emphasizing contractor oversight and CMC
systems: SQM, Training, Documentation, Records Management, Technology Transfer,
Validation & Batch Records
* Ensured QA compliance for over $1.2B of product from third party manufacturers
for Sandoz, Inc.
* Led development of a new manufacturing process, tripled production rates for B
iomira, Inc.
Assets to Contribute: Understanding new technologies. Analyzing complex business
challenges and developing solutions. QA with Mfg. Operations background resulti
ng in practical solutions to compliance. Building strategic vendor partnerships
and alliances for optimizing chances of success in relying on outsourcing. Stren
gth in dealing with all levels of an organization. Strong leader, mentor, and te
am builder. Experience in FDA PAI preparedness.
SELECTED ACCOMPLISHMENTS
Built QA department for Allos Therapeutics, Inc. Virtual company preparing for c
ommercialization of oncology therapy had no QA systems to support CMC. Created s
ystems for Document Control, Training, Supplier Quality Management for goods and
services (Quality / Technical Agreement based), Change Control, Disposition for
drug substance/drug product goods and services, and other oversight systems.
Ensured QA compliance for over $1.2B of product from third party manufacturers f
or Sandoz Inc. Company expanded into generic drug market without having the requ
ired FDA controls for outsourced manufacturers.
Created infrastructure and established administrative procedures ensuring FDA co
mpliance. Expanded program to include international vendors of outsourced produc
ts accounting for two-thirds of annual revenue.
Led development of a new manufacturing process, tripled production rates for Bio
mira, Inc. Organization lacked procedural compliance measures to ensure producti
vity in a time-limited oxygen-sensitive environment. Led production team in iden
tifying process to achieve aseptic production without automation. Published proc
edures in Journal of Validation Technology and presented discovery to ISPE commu
nity.
CHRONOLOGICAL EXPERIENCE
ALLOS THERAPEUTICS, INC. - Westminster, CO 2008-2009
Director, QA
Created core of key QA systems, Document Control, Training, SQM for goods and se
rvices (Quality Agreement based), Change Control, Batch Disposition for drug sub
stance/drug product goods, and others, for a virtual company preparing for comme
rcialization of a cytotoxic aseptic oncology injectable therapy.
* Achievements include: Contractor preparation for FDA PAI-readiness, FDA Sponso
r Inspection coordination, Training program established for Good Practices (GxP)
for Nonclinical, Clinical & Manufacturing, and Technical staff.
COCHLEAR AMERICAS - Englewood, CO (device consulting contract) 2007
Quality Engineer
Quality engineering support: clinical trial monitor procedural documentation, sy
stem implementation, and training.
SANDOZ INC. - Broomfield, CO 2003 - 2006
QA Manager, 3rd Party Compliance
Responsible for the GMP compliance management of partner and licensing relations
hips and contract production of pharmaceutical finished dosage forms.
* Achievements include: Business group collaboration for front-end assessment of
risk and quality policy (review of Supply Agreements for consistency with quali
ty policy, structuring Quality Agreements as suitable for relationship); SQM man
ufacturer status approval; quality performance monitoring through audit, Investi
gation involvement, Annual Product Reviews, document review and approval, valida
tion review and approval, and others as appropriate to corporate partnership.
ILEX ONCOLOGY, INC. (now Genzyme) - San Antonio, TX 2001 - 2003
Associate Director, Quality Assurance
Directed GMP/GLP oversight activities. Achievements include: internal/external a
udit for compliance to FDA/international GMP/GLP regulations; primary QA liaison
for US and international 3rd party manufacturing; FDA interaction for follow-up
inspection which resulted in a "zero findings" report; third party development
and manufacture of: biological injectable, cytotoxic injectables, tableted cycto
toxic; standardized and streamlined interactions with third party contract manuf
acturing organizations through documentation and personal interaction; created i
nternal systems for Change Control, Deviation Reports, Material Review Board, An
nual Product Review, drug product release, international regulatory change notif
ication (e.g., EMEA Type II variation).
INCELL Corporation, LLC - San Antonio, TX (consulting contract) 2001
Manufacturing Coordinator
Evolved GMP-compliant manufacturing and documentation systems for the aseptic ma
nufacture of cell culture media used in drug/diagnostic development for this 10-
person start-up venture.
* Achievements include: process optimization and scale-up, manufacturing batch r
ecord creation and review, QC test methods, equipment controls, Quality Manual,
support documentation for DMF.
DPT Laboratories - San Antonio, Texas 1999 - 2000
Production Supervisor
Supervised the activities of 45 manufacturing staff operating high-speed fillin
g lines for cGMP-regulated CLOGS (creams, lotions, ointments, gels and suspensio
ns).
BIOMIRA INC. (now Oncothereon) - Edmonton, Alberta 1991 - 1999
Director, Manufacturing & Materials
Directing the activities of 40 people and budget of $3.5MM in the Clinical Trial
Material production of in vivo lines of cancer therapeutics and imaging agents,
including the functions: Bioproduction and Parenteral Operations (cleanroom and
barrier isolator technology), Purchasing & Material Control (contracts, shippin
g, receiving, inventory), Manufacturing Engineering, Facilities / Metrology.
* Achievements include: TQM team member, project management teams, validation st
eering committee, contract business development team, long term facility plannin
g team, led the Task Force for selecting, implementing, and validating an MRP sy
stem; established systems for contracting business in and out, transferring R&D-
phase products into manufacturing, validating cleanroom operation [systems, equi
pment, processes]; documentation for all areas to meet FDA cGMP (21 CFR Part 211
), EC, and Canadian HPB requirements.
GENETIC SYSTEMS CORPORATION - Seattle, Washington In vitro diagnostics
Manufacturing Engineer; Bulk Production Supervisor
PROFESSIONAL PRESENTATIONS & EDUCATION
Training Dynamics-cGMP Basic, Part 820, Training Dynamics-cGMP Advanced, Part 82
0
ISPE-Barrier Isolator Technology, Cleaning Validation of a Stand-Alone Isolator
B.S. Biochemistry - University of Texas, Arlington
M.B.A. Program, Core Courses - Seattle Pacific University