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Biopharmaceutical manufacturing site leader experienced in multiple focus areas including Operations, Quality Systems, portfolio/program management, regulatory communications, validation and more. Proven ability to lead teams to successful delivery and value creation with focus on collaboration and team development. Enjoys being a transformational leader, advancing the culture of Quality and Excellence in every aspect of our business.
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Vp - Site LeaderPfizerUnited States
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Sr. Director Manufacturing ExcellencePfizer Jun 2022 - PresentNew York, New York, Us
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Interim Site LeaderPfizer Jun 2021 - May 2022New York, New York, Us
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Pfizer Global Supply Site Medical Device/Combination Product Support LeadPfizer Dec 2019 - Jun 2021New York, New York, Us
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Pmo Director And Site Remediation LeadPfizer Mar 2016 - Dec 2019New York, New York, Us
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Quality Senior Program ManagerHospira, Now A Pfizer Company Jul 2012 - Mar 2016Lake Forest, Il, UsProgram Manager for quality transformation projects, encompassing regulatory commitment CAPAs and compliance continuous improvement targets. Provides Quality oversight to large-scale implementation of automated visual inspection equipment for finished product inspection. Quality Management Review owner and facilitator ~ Quality Metrics reporting for FDA risk-based approach to inspections ~ Annual Product Quality Review ~ Significant product/facility investigation support ~ Regulatory communications and audit support ~ Champion of Quality improvement projects ~ Site Quality lead for integration of Hospira and Pfizer Quality Systems. -
Strategic Planning & Operations Senior ManagerAmgen Mar 2011 - Jun 2012Thousand Oaks, Ca, UsBulk biopharmaceutical manufacturing site strategy and business office lead. Responsibilities include strategic planning, long-range and annual goal setting, strategic portfolio alignment and performance metric trending for two manufacturing plants. -
Project ManagerAmgen Apr 2009 - Mar 2011Thousand Oaks, Ca, UsStrategic Planning, Project Portfolio Management, Resource Management and Performance Metrics
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Senior Validation EngineerAmgen Apr 2001 - Apr 2009Thousand Oaks, Ca, UsProject Manager of all aspects of bulk biopharmaceutical validation activities, ranging from new product introductions to product lifecycle maintenance tasks. Varied experience with equipment commissioning and qualification, cleaning validation, and process validation.
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Validation SpecialistDsm Catalytica Pharmaceuticals 1999 - 2001Client-facing contract manufacturing QA Validation representative at fill/finish contract manufacturing facility. Wide scope of validation experience: drug product introductions and process validation, CIP, COP, SIP, autoclave & depyrogenation, controlled temperature chamber, HVAC, fill weight testing, media fills, transportation validation, batch record and SOP review.
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Clinical Pathology Laboratory InternVidant Medical Center 1998 - May 1999Greenville, Nc, UsFull-time internship with rotations in all departments of the Pathology Laboratory - Blood Bank, Chemistry, Microbiology, Virology, and Hematology.
Amy Owen Skills
Amy Owen Education Details
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East Carolina UniversityClinical Laboratory Science -
Colorado Technical UniversityProject Management
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Stanford UniversityAdvanced Project Management Certification
Frequently Asked Questions about Amy Owen
What company does Amy Owen work for?
Amy Owen works for Pfizer
What is Amy Owen's role at the current company?
Amy Owen's current role is VP - Site Leader.
What is Amy Owen's email address?
Amy Owen's email address is am****@****gen.com
What is Amy Owen's direct phone number?
Amy Owen's direct phone number is +121257*****
What schools did Amy Owen attend?
Amy Owen attended East Carolina University, Colorado Technical University, Stanford University.
What skills is Amy Owen known for?
Amy Owen has skills like Validation, V&v, Biotechnology, Quality System, Cleaning Validation, Change Control, Fda, Sop, Gmp, Biopharmaceuticals, Pharmaceutical Industry, Business Process Improvement.
Who are Amy Owen's colleagues?
Amy Owen's colleagues are Nickie Ryan, Pmp, Ccra, Melissa John, Dominique Menuet, Mónica García, Mike Julien, Oscar Enrique Ponce Ornelas, Tom Barnett.
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