Stephanie Skipper Email and Phone Number
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Master of Science in Pharmaceutical Quality Assurance and Regulatory Affairs - Temple University 2005. Attained Certifications include CMQ/OE, CQA, PMP, ITIL, ISO 9001:2015 Auditor.Active consultant 2005 - 2024 (see projects section). Hands-on experience developing, managing and improving quality management systems in the pharmaceutical, medical device and biotechnology industry. Highly experienced and skilled at designing and deploying new quality systems for start-up and transitional biotechnology and medical device organizations. Unique career experience includes chief quality officer, vice president of quality, director of quality roles reporting to C-suite officers. In-the-trenches (task owner) experience includes from-scratch QMS build-out, QMS Leadership, Audit, Deviation and CAPA Remediation, Knowledge Management (Document/Record Control), Intra-company Quality Agreements, Transition and Acquisition Quality, and Clinical Quality Assurance (study responsibilities spanning the biologic drug development process from research and development phase through phase III clinical trials.) Experience validating computerized systems, software and environments (GAMP 5 and FDA Guidance General Principals of Software Validation). Validation of multi-tenant software platforms for SaaS provisioning supporting a vast array of customer-specific IT service delivery strategies and requirements. Validated 510K - Registered medical device computerized systems.Interested in opportunities involving introduction of AI in Quality Management Frameworks and Operations in FDA regulated scenarios - Strategy, Planning, Deployment projects considering implementing AI in quality processes are of great interest. Current continuous learning activities include online study of Python coding and GPT Prompt Engineering (Udemy Courses).Core Competencies Include:Quality Management Leadership | Regulated Software Validation| Quality System Development | Quality Audit | Process Improvement | Change Management | Quality System Regulatory Compliance | FDA | ISO Standards: FDA 21CFR11, 21CFR20/211, 21CFR 820, GCP/ICH, GAMP 5, ISO 9001:2015, ISO 13485:2016
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SwareLawrenceville, Ga, Us -
Owner/Operator And Principal ConsultantTicalion Quality Management Services, Llc Jun 2004 - PresentQUALITY MANAGEMENT SYSTEMS (19+Years)• Provides independent, objective advice to organizations on strategies to improve the effectiveness of quality management systems and their operational processes. • Develops manuals, plans, procedures, and processes. Performs assessments to guide and assist clients with implementing or remediating FDA -regulated Quality Management Systems, processes and operations or to become accredited by the International Organization for Standardization (ISO).• Performs regulatory functions that intersect Quality and Compliance requirements.• Performs quality assurance functions and activities at levels from task and process owner through chief quality officer.CLINICAL QUALITY ASSURANCE (6 Years)• Support the clinical project team with clinical study document development.• Assess clinical trial protocols investigator brochures, IRB documentation, case report forms, clinical study databases, trial master files and study data.• Risk-based planning and executing the study audit schedule.• Evaluate data transfer, data format specifications, data management systems and data management processes.Standards: FDA GCP Regulations and ICH standardsQUALITY AUDIT (19 Years: 284 audits performed)• GMP/820 retail certification auditor. • Provide independent third-party audit of quality management systems and operations.• Provide internal quality audits, mock FDA PAI and gap analysis audits. Standards: FDA 21CFR11, FDA 21CFR210/211, 21CFR820, FDA GCP Regulations and ICH standards, ISO 9001:2015, ISO 13485:2016COMPUTER SYSTEM & SOFTWARE VALIDATION (15 Years)• QMS software selection assistance• Develop and execute Validation Master Plan, Trace Matrix, Risk Assessment, IQ/OQ/PQ Test Scripts, Summary Report, SOPs, Error reports. • Primary experience with computer software used in medical devices and regulated quality management systems. Extensive data center validation for regulated customers. -
Head Of QualitySware Apr 2024 - Sep 2024Chelsea, Massachusetts, UsApril 2024 I came into a fast-paced start-up software company with operations ongoing and a need to preserve the forward progress of the organization as a whole and consequently, requiring that I be on task as a detailed oriented professional manager and leader capable of contributing to forward progress of ongoing quality initiatives under intense time constraints. The company was in a unique situation having multiple major audits all due between May and Sept 2024 and having lost its entire quality department staff. Determined not to let a single milestone slip its timelines, I prioritized the milestones, structured my priorities and addressed each challenge flawlessly.Within 180 days I successfully delivered the following list of major initiatives: 1. Successful customer qualification audits2. ISO 9001:2015 certification audit and report with no observations and no recommendations. 3. SOC 2 certification audit and report with no observations and no recommendations. 4. Quality Reviewer and Approver with Software Release Authorization for the company’s flagship software product.5. Maintained the Quality Management System and operations as a one-person organization. Assured completion of quality department activities necessary to pass ISO 9001:2015, SOC 2 and customer audits.6. Worked with the product development, engineering, and validation teams to implement artificial intelligence (AI) capabilities into the software product providing guidance on 21CFR11 compliance considerations, validation strategies, and gaining industry acceptance of AI in a QMS software product.Unfortunately, the internal constraints of a start-up could no longer support our continued engagement, although I would have liked to have continued on to see my new initiatives to develop a customer self-service audit portal and to further develop AI and QMS functionality into the Res_Q software platform to fruition. I am a pro consultant available for 1099 or W2 assignments.
Stephanie Skipper Skills
Stephanie Skipper Education Details
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Temple University School Of PharmacyPharmaceutical Quality Assurance And Regulatory Affairs -
Temple UniversityEnglish And Biology
Frequently Asked Questions about Stephanie Skipper
What company does Stephanie Skipper work for?
Stephanie Skipper works for Sware
What is Stephanie Skipper's role at the current company?
Stephanie Skipper's current role is Quality Management System, Quality Audit, SaaS Software Quality Assurance / Validation : FDA Medical Device and Biotechnology; ISO 9001, 13485.
What is Stephanie Skipper's email address?
Stephanie Skipper's email address is ss****@****llc.com
What is Stephanie Skipper's direct phone number?
Stephanie Skipper's direct phone number is +141024*****
What schools did Stephanie Skipper attend?
Stephanie Skipper attended Temple University School Of Pharmacy, Temple University.
What skills is Stephanie Skipper known for?
Stephanie Skipper has skills like Validation, Quality Assurance, Fda, Quality System, Gmp, Regulatory Affairs, Biotechnology, Pharmaceutical Industry, Medical Devices, Capa, Quality Auditing, Process Improvement.
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