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10 years' experience in Bio pharmaceutical industry Quality Assurance management and Process manufacturing. Lifelong learner of QMS concept, architecture and improvement activities. Purposely driven mindset practitioner of Data integrity and monitoring risk analysis. Forward thinker in pursuit of Data as a lifecycle side by side productions processesAt Nature's Toolbox, commitment to quality and strategic project management has been the cornerstone of our recent initiatives. Leading the External Operations team, we have enhanced partner communication, secured supply chains, and strengthened risk mitigation strategies. Our focus on quality assurance and data analysis has established robust protocols, ensuring the delivery of excellence in every project phase.Previously, as a Quality Assurance Operations Manager at Bristol Myers Squibb, we championed quality forums and governance processes, significantly improving unit performance through cross-functional collaboration. Our dedication to continuous improvement was evidenced by the development and monitoring of key performance indicators, all contributing to our reputation for upholding the highest standards in the pharmaceutical industry.
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External Operations Project ManagerNature'S Toolbox, Inc. (Ntx) Jun 2023 - Aug 2024New Mexico, United States Development of Project Scope, monitoring deliverables and re-enforcing goals Secured supplies cross functionally with supply chain and procurement External communication partners, Schedule Timeline maintenance and implementation, Contract service proposal, invoicing objectives deliverables. Quality Assurance Documentation and data analysis coordination establishment of protocol Internal and external Facility Audit establish quality agreements between partners Risk mitigation development for new and existing partnerships. Assessment of implementation of innovation and growth to match business needs. -
Quality Assurance Operation Project ManagerBristol Myers Squibb Dec 2021 - Jun 2023United States Lead for quality forums and governances for master batch record review, creation, change controls, and tech transfer of new clinical and commercial molecules. Provide feedback and coaching to commercial and clinical development that creates a collaborative environmental enhanced unit performance and integration across functional departments. Develop, maintain, and act upon quality key performances indicators. Inspection response and CAPA team member, responsible for supporting internal audits and global Health Authority inspections. Quality reviewer and approver for investigation records and CAPA records, including medium and high-risk events. Team lead for material defect reduction project, aimed at improving the response and vendor CAPA for leaks and other material defects identified during incoming QC release. Function as delegate for Quality Assurance Operations senior manager, as needed, in department and project meetings. -
Field Quality Assurance Sr. SpecialistBristol Myers Squibb Feb 2018 - Dec 2021Massachusetts, United States Provide Quality Assurance oversight of cGMP operations in the Single use facility Building Review of manufacturing batch records (MBRs) and documents for Lot release of drug substance Author, review and implement site standard operating procedures (SOPs), in accordance with global corporate procedures and cGMP regulatory guidance. Provide Quality oversite and guidance for atypical events in operations Review, approve, and provide oversite for quality master data.
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Senior Process SpecialistBristol-Myers Squibb Dec 2014 - Mar 2021Devens, Massachusetts
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Tech IiShire Pharmaceuticals Aug 2009 - Dec 2014Lexington Ma- Experience with New MFG start-up for Human enzyme replacement therapy disposal Bioreactor process. - Experience in the manufacturing process of media’s, buffer solutions and cell culture with inoculation/bioreactor/recovery process• Lead peer and technical training for Nova maintenance, cell culture monitoring, production schedule operations and Safety • Assist with updating and revising Standard Operating Procedures (SOPS) and Batch Records creation/review• Direct involvement in the commissioning and validation of manufacturing equipment • Schedule and coordinate project activities for new drug substance and process improvement• Implemented various cross training processes for 3rd shift• Perform maintenance and functional standardization on manufacturing bench top equipment -
Purchase To PayLonza Biologics Feb 2007 - Jul 2009Portsmout Nh• Updated and revised SOPs and training material• Performed monthly and annual audits: payroll, travel expenses, contractor services and projects repair of process and manufacturing equipment maintance.• Maintained current data SAP involving invoicing, check • Track wise trained• Requested certifications of conformance compliance from vendors
Heidi Stevens Skills
Heidi Stevens Education Details
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Biology/Biological Sciences, General
Frequently Asked Questions about Heidi Stevens
What is Heidi Stevens's role at the current company?
Heidi Stevens's current role is Quality Assurance operations manager.
What is Heidi Stevens's email address?
Heidi Stevens's email address is he****@****bms.com
What schools did Heidi Stevens attend?
Heidi Stevens attended Great Bay Community College.
What skills is Heidi Stevens known for?
Heidi Stevens has skills like Validation, Sop, Cell Culture, Trackwise, Gmp, Biotechnology, Capa, Biopharmaceuticals, Cgmp Manufacturing, Aseptic Processing, Sop Development, Lims.
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Heidi Stevens
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Heidi Stevens
Sr Middle Market Territory Manager At Nationwide InsuranceGreater Syracuse-Auburn Area1harleysvillegroup.com
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