Diane M. Fehrenbach

505-***-**** acyv1u@r.postjobfree.com

Quality/Operations/Manufacturing /Information Technology

Proven leadership success overseeing large-scale global organizations, resources and projects across 7x24 operations, multi-site and internationally dispersed teams. Leverages a cross-functional skill set that integrates technology, process efficiency and quality to drive the highest levels of performance across business operations while managing human resources. Completed many complicated, global implementations within aggressive timeframes while consistently delivering exceptional levels of work quality. Career spans across clinical, medical, pharmaceutical, devices, semiconductor and solar industries.

Core Competencies

Proven Leader/Manager Balance

Employee Relations and Policy

Inventory Control/Materials

Global Worldwide/Team Oversight

Service Delivery Consultant

LEAN/Process Efficiency Expert

Strategic Planning & Execution

Innovative Process Efficiency Solutions

Building Organizations Ground Up

Senior Project Management

Healthcare IT/Patient Experience

Diversity Staffing and Recruiting

ISO 9001, FDA and cGMP Expert

Operations Management Expert

Extensive Performance Management

ITIL Foundations v3 Certified

Quality Assurance Management

Group Leadership & Coaching

Business Analyst

Document Control Specialist

Quality Control/Regulatory Audits

Education

Bachelor of Science in Microbiology, University of Wyoming

Graduate Certificate: Transformational Leadership in Healthcare Management, UCLA

Certificate: Paralegal Studies, Boston University

Member of the American Quality Society

Professional Experience

UNIRAC, INC. – Quality Assurance and Supply Chain Manager (August 2015-November 2016)

Responsible for ensuring the systems and procedures operated within the company are ISO 9001/14001/18001 compliant. Manages and leads the company’s quality program, including the continued ISO 9001 certification and procedures, as well as leading the transition to 9001:2015. Keeps senior management abreast of significant developments identified during quality control activities. Investigates customer complaints regarding product performance, specifications, and reliability. Conducts internal and supply chain audits; creates quality technical specifications for suppliers and control plans and works with the design team. Leads change control and training systems and compliance. Supervises and conducts internal audits to assess the effectiveness of controls, accuracy of financial records, efficiency of operations, and compliance with governmental regulation. Works closely with internal clients at all levels in developing audit findings and recommendations regarding business process optimization, internal control and compliance. Reviews work papers. Performs complex testing procedures. Participates in the development and implementation of risk assessments and audit plans. Executes procedures and reviews work papers supporting external audit. Assesses and effectively manages all of the risks associated with their business objectives and activities to ensure activities are in alignment with the risk management framework. Knowledge of the values and practices that align customer needs and satisfaction as primary considerations in all business decisions, and ability to leverage that information in creating customized customer solutions.

VITALITY WORKS, LLC - Operations Manager/Executive Staff (2014)

Operations Manager responsible for the oversight of Receiving, Inventory Control, Purchasing, Materials, MRP, Processing, Packaging, Labeling and Shipping ensuring both contract and private label fulfillment of herbal supplements. Increased the accuracy of inventory from 12% to 88% and reduced late shipments of product from 90% to approximately 5% in first three months. Ensured that GMPs for Dietary Supplements, Kosher requirements and FDA guidelines were adhered to. Acting Human Resource Manager while developing performance management and employee policies. Liaison to both internal and external customers. Developed trend data and indicators for VW.

INTEL CORPORATION

Health and Life Sciences Project Manager (2013 - 2014) Led the incubation of innovative experience-driven health and life science solutions by driving healthcare process efficiency and root cause analysis through the use of ITIL, LEAN techniques and technology education. Defined, facilitated, educated physicians and directors, and executed strategy to improve delivery of services such as patient intake and discharge. Led multiple project teams both internally and externally, interacted with management and health care providers, both at Intel and in collaboration with hospitals and clinics. Emphasis was on technology driven patient-centered care models and efficient clinical processes. Led strategic planning for health vertical.

Information Security Manager (2006 - 2013) Effectively led and managed the Compliance Engineering Team consisting of seven application developers, one project manager and four agents. Owned the Enforcement/ Compliance applications and patching for 100K servers and 200K clients. Managed the agile development of applications supporting unique security requirements and subsequently integrating with Enforcement and Compliance applications. Facilitated LEAN initiatives and process efficiency workshops annually, inside and outside the organization, identifying, automating and implementing numerous efficiencies and change management initiatives across global business processes. Provided on-going leadership to ensure Intel's computing assets secure and vulnerabilities mitigated and that plans were in place and clients/servers patched such that computing were never vulnerable to malicious attacks. Owned the SLAs and OLAs documenting the services provided, the requirements and responsibilities of both the provider and the customer and a detailed description of any escalation path. Utilization of ServiceNow for 1st response, directed the 2nd and 3rd responders when escalated. Section lead for the IT Emergency Response Team as vulnerabilities threatened.

Among some of the accomplishments are:

Successfully led the re-tooling of the the Patching Enforcement process to automate and eliminate significant human error for the IT Infrastructure Server owners and admins

Facilitated and developed the global roadmap to significantly improve the server patching business and eliminate 80% of the non-standard work tasks and manual labor, drastically reduced complaints from customers

Led, managed and drove the server patching process to become 90% standardized and a 100% automated application for globally increasing the customer base by 10% (+10K) in the following six months

Led the Compliance Engineering Application Developer Team to an overall increase of 20.1% in engineering work with the same number of headcount

Drove the framework and configurability to allow all enforcement applications to send progressive levels of consistent, automated policy violation notifications system across corporate apps

Drove the automation of a very manual, spreadsheet process for the legal disposition of EOL and Migration of Collaborative Sites (2012 requests exceeded 15K) by creating a self-service process from point of entry thru disposition allowing 90% disposition without human intervention

IT Corporate Investment Recovery Global Operations and Disposition Manager (2006-2007) Responsible for leading and managing the team that executed all tactical operations within the Corporate Investment Recovery Program, including managing the reuse, resale, donation and scrap surplus environment for all Intel groups globally. Saved $9M across the company the first year by making decision to rescue and resell assets that were no longer needed. Planned and defined strategic efforts to expand the global program.

F11 and F11XSort Manufacturing Manager (1996 - 2005) Led the Greenfield startup and ramp of the 300mm HVM Sort Operations, including all aspects of creating vision to organizational capabilities, staffing, training, and ensuring output was tested, sorted and shipped in a safe and quality manner. Accountable for a highly demanding output schedule. Virtual Factory Sort Leader and conduit across many organizations and teams. Established the vision and led all corresponding strategies to shift the role of the Manufacturing Technician to support the highly automated and technical capability required for future Sort operations. .

FAB 11 Lithography Supervisor (1993 - 1996) Accomplished a successful factory startup of several leading edge products. Surpassed factory and area goals for quality, safety and output.

Microcontamination Control Engineer (1990 - 1993) Accountable for monitoring and continuous improvement of a Class 1 Clean Room environment. Authored and published technical paper on electrostatic discharge in cleanrooms.

Pre-Intel Corporation – Concentration in Medical/HealthCare/Pharmaceutical

CONSULTANT, COTA Biotech, 4275 Balloon Park Road NE, Albuquerque, NM. Designed a QC/QA program for a government testing contract that would test all Navy personnel for HIV.

QUALITY ASSURANCE SUPERVISOR, Burroughs Wellcome Co., Greenville, NC. Supervised various aspects of the Production Support/ Microbiological Services & Validation Department for a Sterile/non-sterile pharmaceutical manufacturer including environmental control, particulate analysis, water testing, raw material testing, preservative challenge, etc. Wrote and developed departmental procedures, reports, and validation protocols. Trained and supervised QC personnel.

QUALITY CONTROL MANAGER, Adria Laboratories, Albuquerque, NM. Managed all aspects of raw material, in-process/ end-product QC testing for a pharmaceutical manufacturer of sterile parenterals under strict GMP and FDA guidelines. Led efforts to pass all FDA audits. Supervised all aspects of the Quality Control Microbiology Department and AQL inspection (in-process/end product), labeling and packaging, and end-product release. Responsible for environmental monitoring, equipment and systems validation, monitoring of the feed water/WFI systems, pyrogen and sterility testing, microbial identifications. Responsible for metrics and indicators.

QUALITY CONTROL MICROBIOLOGIST/SUPERVISOR, Summa Manufacturing Corp. Class 100 Pharmaceutical Manufacturing.

ENVIRONMENTAL SCIENTIST, NM Environmental Division, Radiation Protection Bureau, Santa Fe, NM.

RESEARCH TECHNOLOGIST, Inhalation Toxicology Research Institute, Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM. Immunology and Microbiology research.

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