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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.