Phil Carpenter work email
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Phil Carpenter personal email
Experienced Quality professional in the biopharmaceutical and medical device industries. Successful in developing staff, building teams, managing multiple projects, developing quality systems for startup operations, Internal and Supplier auditing, improving existing process efficiency, and managing clinical and commercial product release.
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Director Of Quality AssuranceTango Therapeutics Oct 2022 - PresentBoston, Massachusetts, Us -
Associate DirectorTakeda Dec 2019 - Oct 2022Tokyo, JpDepartment Name Change -
Associate Director Of Imp QualityTakeda Dec 2019 - Dec 2019Tokyo, Jp -
Principal Gmp Qa Manager, Investigational Medicinal ProductsTakeda Oncology Feb 2017 - Dec 2019Cambridge, Ma, Us -
Gmp Quality Program ManagerTakeda Oncology Jun 2016 - Feb 2017Cambridge, Ma, UsWork with CMOs to develop Process Validation master plans and protocols for Biologic Investigational Medicinal Products- Drug Substance & Drug Products.Oversee Process Qualification execution, facilitate the transfer of Phase III clinical material manufacturing to Commercial Drugs -
Senior Quality Systems EngineerVericel Corporation Jun 2014 - Jun 2016Cambridge, Massachusetts, Us• Transition quality systems and standards from parent company to acquiring company• Manage change control and risk management systems• Supervise backroom for 3rd party audits• Implemented Unique Device Identification barcodes for packaging commercial cell therapies -
Quality Systems EngineerGenzyme Biosurgery Jan 2007 - May 2014Paris, France, Fr• Created a job to address the growing needs for harmonizing quality systems and information• Interacted with information technology management to establish international support and priorities for information systems utilized by cell therapies• Implemented documentation approval workflows, reducing document turnaround from 239 day average to 40 days• Site Business Quality Representative; review new systems for GXP compliance and validation requirements• Site Risk Champion; oversee site risk management program and quality risk assessment facilitators• Performed gap analyses with procedures against standards and regulations• Analyzed and developed improvements to the batch record review process• Backroom supervisor for the Audit Readiness team• Quality Reviewer for change control• Implemented an enterprise level label management system under budget and on time.• Managed multi-disciplined project teams to implement LIMS applications and introduced electronic technologies such as bar-coding into cell therapy-based manufacturing• Interacted with Information Technology management to establish international support and priorities for information systems used by cell therapies• Designed and managed the Business Unit web portal -
Qa ManagerGenzyme Biosurgery Apr 2004 - Jan 2007Paris, France, Fr: • Developed a staff of 3 Document Specialists and 2 Auditors.• Conducted internal compliance activities supporting cell therapy manufacturing including documentation control, internal auditing, vendor auditing, design and change control, and quality system improvement• Developed performance metrics for measuring system efficacy and efficiency• Designed databases for document control, internal audit tracking and corrective actions, part number control, vendor assessments, and design and change control• Transformed a poorly regarded department into a successful, respected, service-oriented team• Reviewed batch records to support QA operations during backlog situations -
Qa ManagerCambrex Bioscience Apr 2003 - Apr 2004• Managed a staff of 5 Compliance Specialists servicing multiple client projects for a contract manufacturing organization• Conducted all internal compliance activities including vendor auditing, batch release activities, training . quality system improvements, investigations, and validation review
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Qa ManagerBiogen Idec Sep 2002 - Apr 2003Cambridge, Ma, Us• Established a new corporate quality audit team• Developed staff of lead Auditors for international cGMP and GLP auditing• Wrote procedures defining corporate quality auditing functions• Developed company's first training module for teaching basic auditor skills• Designed audit database for tracking supplier approval and performance metrics for the audit department• Performed pre-assessment audits for contract manufacturing and contract testing vendors• Conducted GMP and GLP audits, and managed international audit schedule
Phil Carpenter Skills
Phil Carpenter Education Details
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Central Connecticut State UniversityMinor In General Science
Frequently Asked Questions about Phil Carpenter
What company does Phil Carpenter work for?
Phil Carpenter works for Tango Therapeutics
What is Phil Carpenter's role at the current company?
Phil Carpenter's current role is Director of Quality Assurance.
What is Phil Carpenter's email address?
Phil Carpenter's email address is pc****@****eda.com
What schools did Phil Carpenter attend?
Phil Carpenter attended Central Connecticut State University.
What are some of Phil Carpenter's interests?
Phil Carpenter has interest in Environment, Science And Technology, Human Rights, Arts And Culture, Health.
What skills is Phil Carpenter known for?
Phil Carpenter has skills like Quality System, Quality Assurance, Fda, Change Control, Gmp, Pharmaceutical Industry, Capa, Sop, Biotechnology, Validation, Quality Management, Quality Auditing.
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