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A proven leader with 20+ years of experience in the pharma/biotech industry. A holistic leader with an Engineering background, Quality mindset, and business savvy known to lead high performing teams and implement systematic solutions. My responsibilities and competencies have grown over the years spanning many roles: Val Engineer, Project Mgmt, Business Mgmt, Quality, and Supply Chain. I am a leader driving strategic growth, motivating organizational performance, and inspiring transformational results.
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Sr.Director Of Global Supply QualityAmgen Jul 2024 - PresentThousand Oaks, Ca, UsLeading a team of 35+ Quality Assurance professionals accountable for Quality oversight of 40+ contract manufacturing organizations (CMOs) throughout North America, oversight of 35+ contract laboratories in North America and Europe, and Validation at CMOs in North America and Europe. Small and large molecule products from clinical through commercial at all operations stages (API, DS, DP and FDP). -
Director Of External Supply Quality, North AmericaAmgen Oct 2021 - Jul 2024Thousand Oaks, Ca, UsLeading a team of Quality Assurance professionals accountable for Quality and Validation oversight of contract manufacturing organizations and contract laboratories throughout North America.
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Sr. Manager, Supply ChainAmgen Jun 2020 - Oct 2021Thousand Oaks, Ca, UsEstablished and led the Supply Chain team for Drug Product (filling) master data and master scheduling. Enabled operational readiness for transition of plant from Clinical to Clinical/Commercial manufacturing. Expanded planning/forecasting capabilities to include a drug product development plant. Mitigated raw material supply risks during COVID pandemic related supply chain challenges. Amgen Future Operations Leadership rotational assignment.
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Sr.Manager, Quality AssuranceAmgen Nov 2018 - Jun 2020Thousand Oaks, Ca, UsQuality Assurance lead for Amgen's Next Generation Manufacturing startup in Rhode Island. Responsible for establishing the Plant QA organization to deliver Quality oversight through commissioning and qualification, ensure operational readiness for commercial production, and alignment across global plants. Amgen Future Operations Leadership rotational assignment.
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Sr.Manager, Qc Laboratory OperationsAmgen Jan 2016 - Nov 2018Thousand Oaks, Ca, UsLed a multi-layered organization, responsible for 400+ laboratory assets and QC touch-point for manufacturing & utility test samples. Established lifecycle management program, project portfolio governance, and global sample management forum. Responsible for sample management, execution of stability program for global product teams, and management of contracted equipment & laboratory services.
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Sr. Business Manager, QualityAmgen Feb 2009 - Jan 2016Thousand Oaks, Ca, UsManaged all aspects of multi-site Quality business operations. Responsible for strategic/financial planning (~$65M budget), work force management (~160 FTEs), portfolio governance, goal setting, performance tracking, and facilitation of Leadership Team. Owned special projects and programs, such as: Site Environmental Sustainability Program and LAMPX contracted services implementation.
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Project ManagerAmgen Feb 2006 - Feb 2009Thousand Oaks, Ca, UsLed cross-functional and cross-site project/program teams using standardized project methodology (IDEC) to implement manufacturing, environmental and enterprise processes and systems.Projects and Programs delivered: - Enbrel Serum Free Process (SFP)- Enterprise Document Management (EDM) Quality system- Learning Management System (LMS)- Site Risk Management Program- Manufacturing Process Yield Improvement Program- Real-Time Multivariate Statistical Process Monitoring (RT-MSPM) system – EIO award winner- Environmental Sustainability Phosphorous Mitigation Program – EIO award winner- EH&S Risk Analysis Program
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Validation EngineerAmgen Feb 2003 - Feb 2006Thousand Oaks, Ca, Us- Promoted to Val Engineer III in Nov '05: Site representative at corporate Computer Systems Global Forum. Validation lead for implementations of Global Asset Maintenance and Management (GAMMA) system and Laboratory Information Management System (LIMS). Led department (10 staff) during interim vacancy of manager. Oversaw resource allocations, schedule negotiations, document review/approval, and mentoring of new staff. - Val Engineer II: Responsible for manufacturing automation and data information systems. Performed change control assessments, established validation strategies, generated validation protocols/reports.
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Validation EngineerGenentech Feb 2000 - Feb 2003South San Francisco, California, UsVal Engineer lead for custom GMP software information systems (LIMS, MES, EDMS, and electronic Batch Assay History Record) developed through the software lifecycle and maintained through change control process. Managed contractor resources. Developed and delivered training materials to SMEs for test authoring and execution.
Sherry Flaherty Skills
Sherry Flaherty Education Details
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Michigan State UniversityChemical Engineering
Frequently Asked Questions about Sherry Flaherty
What company does Sherry Flaherty work for?
Sherry Flaherty works for Amgen
What is Sherry Flaherty's role at the current company?
Sherry Flaherty's current role is Senior Director at Amgen.
What is Sherry Flaherty's email address?
Sherry Flaherty's email address is sl****@****gen.com
What is Sherry Flaherty's direct phone number?
Sherry Flaherty's direct phone number is (805)-447*****
What schools did Sherry Flaherty attend?
Sherry Flaherty attended Michigan State University.
What skills is Sherry Flaherty known for?
Sherry Flaherty has skills like Biotechnology, Gmp, Validation, Biopharmaceuticals, Cross Functional Team Leadership, Quality System, Project Management, Change Control, Fda, Project Planning, Quality Assurance, Technology Transfer.
Who are Sherry Flaherty's colleagues?
Sherry Flaherty's colleagues are Stephanie Boedeker, Don Kapp, Meiyan Hu, Maria Emilia Lopez Marino, Scott Hirayama, Ken Johnson, Milena Pervan.
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