Project Manager Quality Assurance
Resume:
JoAnne Bate, MBA, RAC, PMP
? ***** Greystone Drive ? Monrovia, MD 21770 ? **********@*******.*** ?
I am a regulatory affairs professional with over 10 years experience in the
biotechnology/pharmaceutical (biologics, drugs, devices) industry & the
Department of Defense supporting pre-clinical to Phase III clinical studies
through to post-marketing. Expert in GMP & CMC. Highly innovative as a
leader in strategic planning, compliance, regulatory submissions (domestic
& international), labeling, & negotiating with the Agency (domestic &
international). Accomplished auditor of Good Manufacturing Practices
(GMPs), Good Clinical Practices (GCPs), & Good Laboratory Practices (GLPs).
Currently working on MS Biotechnology Regulatory Affairs Johns Hopkins
University (expected 2012).
PROFESSIONAL EXPERIENCE
REGULATORY PROJECT MANAGER Apr 2010 - Apr 2011
THE EMMES Corporation, Rockville, MD
. Managed, hired, & led a team of 25+ CRAs/monitors/auditors in launching a
GCP auditing program covering 500 selected clinical sites world-wide
supporting NIH.
. Managed departmental budget of $1.6M by actively tracking & assessing
status.
. Reported on project progress, & implemented changes to achieve successful
project output.
. Developed SOPs (auditing, reporting, etc.), GCP training program, goals,
manual of operations (MOPs), project scope, & departmental polices.
. Authored annual & reports, bi-annual progress reports to client.
Reviewed & advised on monitor's reports.
. Interacted with cross-functional teams, clients, & corporate personnel on
project status, risks, & issues.
. Gained knowledge of Europe, Israel, Korea, Germany, & China regulatory
requirements in launching world-wide clinical trials.
REGULATORY COMPLIANCE MANAGER/PROJECT MANAGER Sept 2007- Apr 2010
MedImmune (subsidiary of AstraZeneca), Gaithersburg, MD
. Hired as GMP & CMC expert by ensuring compliance with regulatory
requirements overseeing submissions & GMP activities.
. Managed corporate review & approval of all USPIs & other regional
prescribing information. Authored package inserts, labels, & labeling for
EMEA & FDA submissions
. Regulatory representative on product development teams providing
regulatory support & advice to research, clinical development, &
manufacturing.
. Provided regulatory intelligence, reviewed, & identified potential
risk(s) to MedImmune business strategies by evaluating competitors &
relevant regional regulations, guidance's, current regulatory environment
& competitor labeling. Authored weekly news letters.
. Participated in the development of policies, standard operating
procedures, & charters.
. Conducted GCP, GMP, & GLP New Hire Orientation training presentations.
Received consistently high marks from participant's evaluations.
REGULATORY AFFAIRS/QUALITY ASSURANCE MANAGER Sept 2000 - Sept 2007
Chemical Biological Medical Systems (DoD Contractor), Frederick, MD
> Regulatory/Submissions/ Standard Operating Procedures:
. Acting Director for 3 years. Managed a regulatory team of 5. Provided
technical briefings.
. Regulatory representative on product development teams providing
regulatory support, strategic planning, and advice to research, clinical
development, CMC, & manufacturing .
. Interacted with responsible departments & led preparation, review, &
assembling of the scientific (non-clinical, clinical, manufacturing) &
administrative sections of submissions to US regulatory agencies.
Responsible for: 3 INDs, 2 NDAs, 1 BLAs, 510(k), protocols, safety
reports, amendments & adverse event reports.
. Prepared for Agency meetings, teleconferences, & other communications.
. Educated teams regarding regulatory risks & implications.
. Utilized technical knowledge & effectively applied regulations &
guidelines to the product development process.
. Facilitated & authored Standard Operating Procedures for GMPs, GLPs, &
GCPs.
. Integral part of gaining approval for use of "Animal Rule" by working
diligently with the FDA.
. Conducted on-site quality audits of biotech/pharmaceuticals for GCP, GMP,
& GLP compliance.
. Received multiple awards & letters of commendation from the Commander for
my regulatory compliance advice, expertise & team effort.
. Member of Proposal Selection Board reviewing & making recommendations.
REGULATORY AFFAIRS LIAISON Nov 1998 - Sept 2000
Clinical Research Management, Inc., Frederick, MD [Research & Development
of Biologics, USAMRIID]
. Successfully managed 40 personnel's training files, managed annual
development & review of SOPs.
. Participated developing GCP & GLP training programs. Developed training
curricula.
. Managed training files in accordance with FDA regulations.
. Participated in the development & review of Standard Operating
Procedures.
. Assisted in GCP audits of the Special Immunization Program.
. Prepared & managed a budget of $1M
REGULATORY AFFAIRS MANAGER May 1993 - Nov1998
SAIC, Biological GMP Manufacturer, Frederick, MD
. Managed the renovations & construction of a biological GMP facility & a
pilot plant adhering to GMP regulations.
. Managed the purchase of FDA compliant capital equipment. Ensured
validation and/or calibration.
. Managed & tracked certificate of analysis (COAs) for raw materials.
Inventoried & managed quarantine & released product.
. Participated in hiring staff by interviewing & making recommendations to
the Director.
. Initiated a cross-training program.
. Facilitated development of SOPs.
. Trained personnel on GMPs, GLPs, & GCPs.
. Authored site visit reports, annual reports, & performance evaluations.
EDUCATION AND TRAINING
M.S. Biotechnology Regulatory Affairs, Johns Hopkins University, 4.0 GPA
Expected 2012
M.B.A. Business Administration; Minor: Regulatory Affairs, Hood College,
3.67 GPA
B.A. Business Administration, Hood College 3.67 GPA
Nursing Program -completed 2 years, Frederick Community College, 3.80 GPA
SPECIALIZED TRAINING/PROFESSIONAL DEVELOPMENT/CERTIFICATIONS
Regulatory Affairs Certification (RAC) Project Management
Professional (PMP)
Good Clinical Practices Human Subject Protection HIPAA
Risk Management Strategy Devices: 510(k), PMA, IDEs
Regulatory Strategies
Clinical Auditing Good
Manufacturing Practices
Good Laboratory Practices
PROFESSIONAL ASSOCIATIONS
. Regulatory Affairs Professional Society (RAPS)
. co-President of Baltimore/Washington Local RAPS Chapter (2004-2009)
. Drug Information Association (DIA)
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