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

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 & 13485, FDA QSR, cGMP, GLP, USDA
Trends & Development: Performance Measurement, Quality Assessment & Ranking
Documentation: Technical Standards, Protocol, Training, Quality Manual, Validation

Managing Partner, Confidential ~ 2011
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

Confidential, California
Managing Partner ~ 2011
Internal Audit for a biotech company, served as Corporate Secretary for a biotech company and provided “Peer-Review” for Technical Reports for the Process Validation and Verification and Cleaning Validation for Pharmaceutical Companies for an international organization. A previous experience included working in a team at a company issued Quality Consent Decree.

Confidential, Rochester, New York (Kelly Scientific Contractor)
Global Regulatory Affairs Manager ~ 2011
Designed and developed 510(k) template, deliverables list, and provided examples for submission to FDA

• Interacted with team members to design templates, facilitating submission to FDA for contact lens & solutions.

Confidential, Management Recruiters of Confidential
Quality Assurance Contractor, ~ 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 position reporting directly to the CEO of the company.
• Management Representative for Quality; 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
• 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-Davis
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)

Confidential-Davis, School of Medicine
Ph.D. in Immunology (Internal Medicine), March 2007
B.A. in Biological Sciences, December 1995
Confidential
M.B.A. in Technology Management, 60% completed courses, 2001

“It is my pleasure to endorseAngelaLeeForeman. I worked closely withAngelabetween 1999 and 2003 through the Sacramento Section of the American Society for Quality (ASQ). Volunteers are the heart of ASQ and so many other organizations. In many ways they are what keep this country great. While serving as an officer on the section board she demonstrated critical skills such as reliability, a propensity for action, and leadership. As a Past President and Chairman of ASQ, I truly understand how important these skills are to ASQ and in business.”

• Jerry Mairani, Past President and Chairman, American Society for Quality
  

“Angelaworked for GE Healthcare as a contractor during a critical stage of Consent Decree remediation.Angelademonstrated the ability to quickly understand the wide ranging and sometimes diverse objectives of her various assignments and deliver results that consistently exceeded expectations. If I was asked to describeAngelain one word - the word I would choose would be "versatile."
For those who have not worked under Consent Decree - the pressure is constant, the urgency starts at "high" and goes up from there, and daily expectations can change by the hour. It takes a special type of person to deliver results in this type of environment. Many tried and didn\'t make it.Angela was one who was able to deliver.”

• David Lockridge,Director of Quality Assurance, GE Surgery
  

“Angelais patient and diligent, and gets the job done.Angelawill ask questions to understand requirements, learn new skills when needed, and can be counted on to deliver. She is also a kind soul and a pleasure to work with.”

• Robert Enzerink,Vice President, Sales & Marketing, Antibodies, Inc

"I have always been impressed withAngela’s thorough understanding and presentation of difficult subject matter. In presenting information to others, she demonstrates her resourcefulness, knowledge and confidence. Additional she is always willing to help others, and is personable and considerate. She is a wonderful role model and co-worker."

• Carol Hood,Traineeship: Superfund Basic Research & Training, University of California-Davis
  

“Ms.Foremanand I served together as volunteers on the Board of the American Society for Quality (ASQ), Sacramento Section 0605. As Secretary, Angelawas a stellar contributor to our organization. She provided agendas in advance, attended all Board meetings, and wrote excellent, actionable minutes. Angelacontributed significantly to our success and was key to documenting our accomplishments; this led to our Section\'s recognition with an ASQ National Total Quality award. I recommendAngelabased upon her enthusiasm, commitment to the job and demonstrated superior performance on our Board.”

• Chris Moore, PMP & CSQE,Project Manager, GovConnect (FirstData Corp)
  

“WhileAngelawas taking several courses for her PhD, she involved herself tirelessly in an outside community activity at NorCal Center on Deafness. As an active team leader, she developed a Cochlear Implant Support Group; coordinated the activities; contacted everyone for networking; brought in speakers to share experiences or products related to the processors; and hosted monthly events as a facilitator. She worked extremely hard, juggling multiple tasks at the same time and not miss a beat. She is very personable and warm at heart and genuine. I love the way she embraces everyone’s thoughts or comments as important and worthwhile. She is a perfect positive role model in overcoming her obstacles and she continues to strive forward!”

• Ginger Cox,Information Systems Analyst, OSHPD

“Angelapatiently and methodically works through highly technical assignments and delivers excellent results. Where others might become mired in details,Angelademonstrates a capability of rapidly and expertly becoming familiar with the technical issues involved then achieving an effective outcome for users of all levels. All the while,Angelamaintains a personable and friendly nature that makes working with her quite pleasant!”

• David Bruce, EVP & Senior Search Consultant, Management Recruiters of Salt Lake City

“Dr.Foremanhas been an active and fully engaged member of the external advisory board with which my center and a wide range of other AAAS programs work. In her role she has served as a clear and strong voice for a diverse range of interests related to creating opportunities for and removing barriers to participation in science and engineering. Dr.Foremanhas participated on panels and working groups within the context of our global organization. Her contribution has demonstrated maturity of understanding and a deep commitment to equity for all.”

• Richard Weibl,Director, Center for Careers, American Association for the Advancement of Science