Objective: Pursuing an Executive position leveraging my extensive experience and training.

Professional Summary

Senior-level director in Quality Assurance and Regulatory Affairs combined with four years instructional experience at a prestigious technical college. Extensive biotech industry experience notable for ISO certification leadership, Management Representative for Quality, Product Review Board Chairperson, regulatory compliance improvement, extensive documentation, and company-wide training.

Dynamic, versatile, and instinctively invested in continuous improvement. Visionary with a penchant for investigation and implementation of latest knowledge and technology.

Standards & Auditing: ISO 9001, FDA QSR, cGMP, GLP, USDA
Trends & Development: Performance Measurement, Quality Assessment & Ranking
Documentation: Technical Standards, Protocol, Training, Quality Manual, Validation

Chronological Order of Work Experience

Regulatory Affairs Manager, Confidential, 2011
Faculty, Confidential, 2007-2011
Quality Assurance Contractor, Confidential, 2007
NIH Pre-doctoral Fellow / Graduate Student, Confidential, 2003-2007
Regulatory Affairs Officer, Confidential, 1997-2003

Quality Assurance & Regulatory Affairs Experience

Confidential, Rochester, New York (Kelly Scientific Contractor)
Global Regulatory Affairs Manager, Global Vision Care ~ 2011
Designed and developed 510(k) template, deliverables list, and provided examples for submission to FDA
Interacted with team members to design a template, facilitating their submission to the FDA for contact lens and solutions.

Confidential
Quality Assurance Contractor, GE Healthcare Surgery ~ 2007
Developed comprehensive documentation of procedures for a business unit providing tools and technologies for diagnostic monitoring systems, data management systems to mobile fluoroscopic imaging systems, navigation and 3D visualization instrumentation.

• Interacted with subject matter experts to gather and correlate raw data relative to procedures.
• Served as lead technical writer creating training and SOP documentation on service/installation procedures compliant with FDA's Consent Decree.
• Performed audits of SOP, procedures, instructions, engineering change orders, and internal, external, and archived documents.
• Provided company-wide guidance on Good Documentation Practice.
• Reviewed quality assurance standards to ensure compliance with blood borne pathogen policy.

Confidential, Davis, CA
Regulatory Affairs Officer ~ 1997-2003
Oversaw Quality & regulatory affairs for supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services and in-vitro medical devices. Managed compliance with ISO 9001, cGMP, GLP,NIH-Assurance, USDAregulations,and FDADevice Manufacturer standards.

• Senior Director level positionreporting directly to the CEO of the company.
• ManagementRepresentativeforQuality; Designed and Implemented: Quality Manual; Complaints, CAPA, Risk Analysis, Design Control, Management Review. Served as Chairperson of Product Review Board.
• Revitalized and enhanced documentation, increasing volume of ISO and quality systems audit records which ultimately resulted in 100% passing rate on internal/external audits.
  
• Angela Lee Foreman, Ph.D.
• Drafted and Implemented: SOP, Validation, QA/QC procedures, product and research processes: risk analysis, customer complaints, equipment and systems validation, calibration verification procedures, and manufacturing process validations for In-Vitro Diagnostic (IVD) manufacturing and OEM (Client projects).
• Lead 100% company-wide internal audits following FDA regulated industry standards for cGMP (CBER/CDRH QSR), GLPs, USDA, OSHA and ISO 9001:1994 guidelines. Ensured compliance with International Conference on Harmonization (ICH) guidelines for medical devices.
• Spearheaded 100% employee quality and safety certification according to state/federal standards.
• Implemented quality systems training; continually improved accountability via internal audits.
• Developed quality policies and procedures, and parent procedures and protocols.
• Drafted ISO 9000 based quality manual and a wide range of technical documentation.
• Reviewed and processed reports for pre-clinical studies adhering to sponsor protocols for laboratory bench assay development and testing.
• Developed and launched risk analysis system as part of design control and process changes.
• Reviewed design control and product development process for maintenance of 510k application.
• Developed and implemented Corrective Action & Preventive Action (CAPA) system.

Biotechnology Experience

Confidential, Rochester, New York
Faculty Member, Science and Mathematics Department ~ 2007 to 2011
Deliver instruction and student mentoring in three majors: Biotechnology, Biology, and Environmental Sciences. Participate on internal and external committees promoting the sciences, research, and the advancement of hearing impaired students.

• Develop and instruct courses in Microbiology, Biotechnology, and Applied Microbiology to deaf and hearing impaired students at NTID; provide instructional support at RIT's College of Science.
• Mentor students throughout master thesis and in undergraduate research programs.
• Represent biology division as a National Science Foundation (NSF) grant review panelist.

Confidential
NIH Pre-doctoral Fellow / Graduate Student ~ 2003 to 2007

• Performed immunology laboratory research (Molecular and Cellular) under the direction UC-Davis School of Medicine scientists in the Division of Rheumatology, Allergy and Clinical Immunology.
• Performed cochlear research as a summer Fellow with Kresge Hearing Research Institute at University of Michigan in Ann Arbor.
• Conducted primary biliary cirrhosis studies as a Visiting Molecular Immunologist for L'Institut Pasteur in Paris, France.
• Investigated effects of environmental contamination on ocean life as a Research Intern for the National Oceanic Atmospheric Administration (NOAA) at the Hatfield Marine Station in Newport, Oregon.

Professional Affiliations

American Society for Quality (ASQ)
Regulatory Affairs Professional Society (RAPS)
Association of Women In Science (AWIS)
American Association for the Advancement of the Sciences (AAAS)

Ph.D. in Immunology
B.A. in Biological Sciences
M.B.A. in Technology Management

Angela Lee Foreman, Ph.D.