Kir Henrici Email and Phone Number
Kir Henrici work email
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Kir Henrici is the CEO of The Henrici Group. Hg provides strategic quality and compliance solutions to regulated life science innovators around the world. Kir has special interest and expertise in Data Integrity & Enterprise Data Management and a passion for the emerging regulatory focus on Big Data, Data Science & AI. She leads in the development + implementation of Global + local Data Governance programs focused on risk-based Data Integrity compliance by-design through the integration of DI requirements + controls within the Pharmaceutical QMS.She has extensive experience serving in Quality and Compliance executive and consulting roles for supporting Pharmaceutical, Biotech, and Medical Device companies to include managing and supporting FDA inspections, and communications and remediation for companies in receipt of 483's, Warning Letters, Untitled Letters, and Import Alerts. As a Principal Consultant, she has had the opportunity to gain diverse and continuous exposure, perspective and knowledge of quality and technical projects and solutions; building core expertise in Quality Assurance/Quality Management Systems, Data Integrity, Risk Management, Regulatory Support, Auditing, Technical Reviews, Validation, Training and Project Management.Kir is a current member of the PDA Task Force for Data Integrity and Co-Lead for the Technical Report addressing the integration of Data Integrity requirements + controls within the Quality Management Systems to promote Data Governance. She is a committee member for the 2020 PDA Data Integrity Workshop and moderator for sessions addressing aspects of Big Data + AI. Kir is co-author/contributor for several industry guidance reports/publications including PDA/DHI Book: Assuring Data Integrity for Life Sciences, and has developed presentations and training modules for key industry forums to include PDA, PDA/FDA Joint Regulatory Conference, PCCIG, and IQPC.
The Henrici Group
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CeoThe Henrici Group Feb 2019 - PresentNew York, New York, Us
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Partner/Managing DirectorFaith & Royale Consultants 2012 - Jan 2019UsConsulting firm providing regulatory compliance solutions for FDA regulated industries. -
Chief Consultant/Project DirectorFaith & Royale Consultants 2011 - Dec 2018UsData Integrity Present State Analysis, Initiatives, Audits and ReviewsDevelop and execute Data Integrity initiatives, Present State Analysis', audits and reviews. Advise on the development and implementation of global/site level Data Governance programs to include designing and executing DI focused audits, assessments and/or technical reviews of management controls, Quality Management Systems, functional areas and associated manual and computerized systems. Provide ongoing expertise and support for the remediation of data integrity risks and non-compliance to include corrective action plans, investigations/CAPAs, risk assessments and retrospective reviews.
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Chief Consultant / Lead AuditorFaith & Royale Consultants 2011 - Dec 2018UsSterile Injectables/ Biologics/ OSD/ OTC/ Dietary Supplements/ CosmeticsResponsible to audit domestic and international pharmaceutical, biotech, medical device and nutraceutical companies. Developed, planned and executed audits and assessments to include GMP, MOCK, For-Cause, DI, PSA and Supplier Qualification. Audited/reviewed manual and electronic data in support of product quality to include batch manufacturing records, laboratory notebooks, executed protocols, validation packages, and electronically generated data within systems such as Empower 3, LIMS, TotalChrom and Chromeleon. Created, implemented and supported complex, risk-prioritized correction action plans to remediate identified risks and compliance gaps. Designed and executed retrospective reviews for critical/major compliance issues while justifying/maintaing business continuity. Managed tiered communications in regards to audit outcomes and remediation to include Executive and Steering Committee meetings, site meetings, and working sessions.
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Chief Consultant/ Project DirectorFaith & Royale Consultants 2011 - Dec 2018UsAdvised on the development and implementation of global Data Governance initiative for international pharmaceutical firm. Developed and implemented scalable Present State Analysis' to include protocol driven DI audits/assessments across multiple functional areas including Quality Assurance, Manufacturing, Quality Control and Microbiology, R&D and Distribution. Evaluated/implemented the Data Governance structure to include integration of DI principles throughout the organization such as Management Controls, the Quality Management System, functional areas and technical controls. Provided risk-based, remediation strategies and action plans to address DI compliance risks and/or areas of non-compliance. Provided ongoing support for remediation activities to include retrospective reviews, investigations/root cause analysis, creation/modification of quality systems/procedures, and oversight of start-up/ongoing operations. Perform extensive DI reviews of NDA/ANDA applications. Executed DI technical reviews of laboratory (QC and Microbiology) data to include data supporting method validation, stability studies, cleaning validation, process validation and product release. Designed and executed large scale, protocol driven DI CSV assessments for laboratory and manufacturing automated/computerized equipment and systems.
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Quality Project Management @ Johnson & JohnsonVts Consultant 2012 - Dec 2014
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Instructor / DeveloperCenter For Professional Innovation And Education Inc. 2012 - 2014Course instructor for courses delivered as part of the organization's regulatory certification pathway. This role included both the development and delivery of teaching modules. Courses delivered included "FDA Regulations for Pharmaceutical and Biotech Industries" and "Internal and External Auditing for FDA Regulated Industries" in addition to the development and delivery of modules designed to meet specific client needs. Courses were delivered to attendees from a broad spectrum of pharmaceutical and biotech from both US and International Regulatory agencies. The coursework provided attendees with and overview of current FDA expectations as well as compliance remediation strategies. Course evaluations demonstrated a high degree of success with the program, as courses were well-received, consistently meeting and frequently exceeding expectations of all attendees.
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Operations Project ManagerJohnson & Johnson 2011 - 2014New Brunswick, Nj, UsDeveloped and managed large-scale validation initiative to remediate compliance issues for a distribution legacy facility designed to store and distribute finished pharmaceutical products. Successfully incorporated newly rolled-out Enterprise strategy in compliance with regulatory, enterprise and site level requirements to become the primary implementation model for a cross-sector harmonization initiative. Responsible to facilitate stakeholder communication and identify/define roles and responsibilities across multiple sectors. Identified leveraging opportunities to ensure alignment with parallel projects, Successfully satisfied all deliverables within established timelines and resource constraints. -
Quality Assurance / Project ManagerJohnson & Johnson 2011 - 2014New Brunswick, Nj, UsManaged site level assessment of procedures to ensure compliance with timelines and requirements of the Enterprise Standards Harmonization Initiative. Developed and managed quality compliance plan roll-out to assess and implement process improvements to quality systems including Deviation/Investigation Management, Corrective and Preventative Action (CAPA), Change Management, and Risk Management. Lead auditor for internal/external audit program responsible for all phases of audit execution including final reports, remediation, and audit closure. Lead auditor responsible for supplier qualifications audits and assessments. Supported regulatory and internal corporate audits to include front and back room management, documentation, and remediation/response processes. Supported JD Edwards system migration across multiple distribution centers. Created and led investigation training modules for high level interdepartmental implementation. Executed document reviews to include quality agreements, protocols, and technical papers. Evaluated and/or established processes to include the development, and creation and/or amendments of associated policies and procedures. Supported the development and execution of the Quality System Management Review Program in compliance with enterprise and site level procedures to include the identifying key quality metrics to support measurable process improvements.
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Managing DirectorPharm To Label 2011 - 2013Developed curriculum and executed training modules for professionals in FDA regulated industries. Created and delivered Quality Assurance presentations for key domestic and international industry forums including PDA/FDA Joint Regulatory Conference, PCCIG, IQPC and PICs. Designed and led team-building activities and individual-focused improvement strategies for organizations and professionals in the dietary supplement and pharmaceutical industry.
Kir Henrici Skills
Kir Henrici Education Details
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New York UniversityProject Management -
Suny Empire State CollegeBachelor Of Science (Bs)
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The Cooper Union For The Advancement Of Science And Art
Frequently Asked Questions about Kir Henrici
What company does Kir Henrici work for?
Kir Henrici works for The Henrici Group
What is Kir Henrici's role at the current company?
Kir Henrici's current role is Devoted to PATIENTS, passionate about the power of DATA | Pharma & Biotech Consulting | Data Governance & Data Integrity |Founder and CEO at The Henrici Group.
What is Kir Henrici's email address?
Kir Henrici's email address is ki****@****hoo.com
What schools did Kir Henrici attend?
Kir Henrici attended New York University, Suny Empire State College, The Cooper Union For The Advancement Of Science And Art.
What skills is Kir Henrici known for?
Kir Henrici has skills like Fda, Pharmaceutical Industry, Management, Product Development, Strategic Planning, Gmp, New Business Development, Regulatory Affairs, Cross Functional Team Leadership, Quality Management, Marketing Strategy, Biotechnology.
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