Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits

COMPANY	POSITION HELD	DATES WORKED
FDA	CDER Compliance Officer	1/2014 - 8/2016
Dendreon	Manager	1/2011 - 8/2016
CIBA Vision	QA Manager	5/2010 - 9/2012
Revogenex, Inc.	QA Manager	11/2008 - 4/2009
Biogen IDEC	QA Manager - Product Quality Management	9/2007 - 10/2008
Amgen, Inc.	Quality Specialist II	4/2005 - 7/2007
Abbott	Quality Engineer	8/2002 - 4/2005
Wyeth Vaccines	Lead Quality Investigator IV	8/2001 - 8/2001
Cardinal Health	APR - Compliance Specialist	5/1999 - 7/2002

SCHOOL	MAJOR	YEAR	DEGREE
Alabama State University	Microbiology - Immunology	1997	Master Degree
Paine College	Biology - Chemistry	1989	Bachelor Degree

Highlights:

$15,000 in savings after the discovery of a bi-directional supply of city water was learned to have soiled the DI water system supplying the manufacturing suites. Stainless steel valve replacement was prescribed instead of a complete circulating water system upgrade. -Successfully encouraged a 40% reduction in QC Analyticals documentation discrepancies as part of the firm's data integrity project. -Successfully manged three INDs through Phase I approval. Each biological was for oncology indications.

Companies I like:

Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer

P&L responsibilities
Presentation
Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts.
Technology Solutions
Sales Support
Software Implementation
Requirements Analysis & Specification
Leadership
TrackWise
Quality Engineering, SPC
Project Management
MINITAB, SASJMP
GAP Analysis
FDA Compliance Investigations
Technical Writing
Teambuilding/leadership
Presentation Skills
QA Consulting

• TrackWise
• Investigations
• CAPAs
• APRs
• Minitab
• SPC
• SAS-JMP/Discovery
• SAP
• QA
• Compliance
• Medical Device
• Pharmaceuticals
• Biotechnology

Conduct Quality Reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement. Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course. Ensure that the laboratory's activities are conducted in accordance with the company's policies, procedures, and cGMPs. Ensure that the results of all raw material and component samples, in process and finished products sample, stability samples are documented correctly and released in a timely manner. Perform review and approval of laboratory test results and documentation; analyze and interpret data; recommend, review, and approve corrective actions. Develop, review, and revise SOPs and Methods, ensuring accuracy, completeness, and compliance with cGMPs and FDA/EU regulations. Establish and maintain metrics databases to assess the aging of analytical test requests, accuracy of work product on first-pass submission, accuracy of technical review and overall throughput. Coordinate with team leaders to prepare Management Review Metrics for presentation to Upper Management. Publish weekly Lab QA Documentation Discrepancy report to trend progress. Perform Quality Audits of the Laboratory to ensure compliance with the quality control systems, including FDA compliance standards, regulations, and guidelines. Initiate Change Control of QC Analytical Test Forms, Specifications, Test Methods etc.