JANET NEELEY

PO Box 522 Black Hawk, CO 80422 (303) 582-6027 jneeley9@msn.com

DIRECTOR – QUALITY ASSURANCE

Policies & Procedures / Life Cycle--Development to Manufacturing / Aseptic / cGMP / Biologics/
CMC Operations/ Supplier Quality Management / Training / Scale up / Oncology / Outsourcing / CTM
Specialize in supporting pharmaceutical operations while ensuring regulatory compliance in virtual or near-virtual
environments. Provide QA leadership for startup and Fortune 500 organizations in the biotechnical, pharmaceutical,
and diagnostic/device industries. Align R&D initiatives with operational goals, building systems from the ground up to
facilitate commercialization. Adapt practices to maximize results with an economy of resources.
• Regulatory inspection experience, domestic and international (FDA, Canadian HPB, German
cGMP)
• Compliance contractor oversight experience, domestic and international (Germany, India,
Spain, et al)
• 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 Biomira, Inc.

Assets to Contribute: Understanding new technologies. Analyzing complex business challenges and developing
solutions. QA with Mfg. Operations background resulting in practical solutions to compliance. Building strategic
vendor partnerships and alliances for optimizing chances of success in relying on outsourcing. Strength in dealing with
all levels of an organization. Strong leader, mentor, and team builder. Experience in FDA PAI preparedness.

SELECTED ACCOMPLISHMENTS
Built QA department for Allos Therapeutics, Inc. Virtual company preparing for commercialization of oncology
therapy had no QA systems to support CMC. Created systems 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 for Sandoz Inc. Company
expanded into generic drug market without having the required FDA controls for outsourced manufacturers. Created
infrastructure and established administrative procedures ensuring FDA compliance. Expanded program to include
international vendors of outsourced products accounting for two-thirds of annual revenue.
Led development of a new manufacturing process, tripled production rates for Biomira, Inc. Organization lacked
procedural compliance measures to ensure productivity in a time-limited oxygen-sensitive environment. Led
production team in identifying process to achieve aseptic production without automation. Published procedures in
Journal of Validation Technology and presented discovery to ISPE community.

CHRONOLOGICAL EXPERIENCE
ALLOS THERAPEUTICS, INC. – Westminster, CO 2008-2009
Director, QA
Created core of key QA systems, Document Control, Training, SQM for goods and services (Quality Agreement
based), Change Control, Batch Disposition for drug substance/drug product goods, and others, for a virtual company
preparing for commercialization of a cytotoxic aseptic oncology injectable therapy.
• Achievements include: Contractor preparation for FDA PAI-readiness, FDA Sponsor 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, system implementation, and training.

Janet Neeley jneeley9@msn.com 303-582-6027

SANDOZ INC. – Broomfield, CO 2003 – 2006
QA Manager, 3rd Party Compliance
Responsible for the GMP compliance management of partner and licensing relationships 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 quality policy, structuring Quality Agreements as suitable for relationship);
SQM manufacturer status approval; quality performance monitoring through audit, Investigation involvement,
Annual Product Reviews, document review and approval, validation 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 audit 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 cyctotoxic; standardized and streamlined
interactions with third party contract manufacturing organizations through documentation and personal interaction;
created internal systems for Change Control, Deviation Reports, Material Review Board, Annual Product Review, drug
product release, international regulatory change notification (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 manufacture 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 record 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 filling lines for cGMP-regulated CLOGS
(creams, lotions, ointments, gels and suspensions).

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, shipping, receiving, inventory),
Manufacturing Engineering, Facilities / Metrology.
• Achievements include: TQM team member, project management teams, validation steering committee, contract
business development team, long term facility planning team, led the Task Force for selecting, implementing, and
validating an MRP system; established systems for contracting business in and out, transferring R&D-phase products
into manufacturing, validating cleanroom operation [systems, equipment, processes]; documentation for all areas to
meet FDA cGMP (21 CFR Part 211), EC, and Canadian HPB requirements.

GENETIC SYSTEMS CORPORATION (now BioRad) – Seattle, Washington In vitro diagnostics

Manufacturing Engineer; Bulk Production Supervisor

PROFESSIONAL PRESENTATIONS & EDUCATION

Training Dynamics—cGMP Basic, Part 820, Training Dynamics—cGMP Advanced, Part 820
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
Janet Neeley jneeley9@msn.com 303-582-6027