Phil Carpenter

Phil Carpenter Email and Phone Number

Director of Quality Assurance @ Tango Therapeutics
Phil Carpenter's Location
Greater Boston, United States, United States
Phil Carpenter's Contact Details
About Phil Carpenter

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.

Phil Carpenter's Current Company Details
Tango Therapeutics

Tango Therapeutics

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Director of Quality Assurance
Phil Carpenter Work Experience Details
  • Tango Therapeutics
    Director Of Quality Assurance
    Tango Therapeutics Oct 2022 - Present
    Boston, Massachusetts, Us
  • Takeda
    Associate Director
    Takeda Dec 2019 - Oct 2022
    Tokyo, Jp
    Department Name Change
  • Takeda
    Associate Director Of Imp Quality
    Takeda Dec 2019 - Dec 2019
    Tokyo, Jp
  • Takeda Oncology
    Principal Gmp Qa Manager, Investigational Medicinal Products
    Takeda Oncology Feb 2017 - Dec 2019
    Cambridge, Ma, Us
  • Takeda Oncology
    Gmp Quality Program Manager
    Takeda Oncology Jun 2016 - Feb 2017
    Cambridge, Ma, Us
    Work 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
  • Vericel Corporation
    Senior Quality Systems Engineer
    Vericel Corporation Jun 2014 - Jun 2016
    Cambridge, 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
  • Genzyme Biosurgery
    Quality Systems Engineer
    Genzyme Biosurgery Jan 2007 - May 2014
    Paris, 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
  • Genzyme Biosurgery
    Qa Manager
    Genzyme Biosurgery Apr 2004 - Jan 2007
    Paris, 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
  • Cambrex Bioscience
    Qa Manager
    Cambrex 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
  • Biogen Idec
    Qa Manager
    Biogen Idec Sep 2002 - Apr 2003
    Cambridge, 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

Quality System Quality Assurance Fda Change Control Gmp Pharmaceutical Industry Capa Sop Biotechnology Validation Quality Management Quality Auditing Quality Control Regulatory Affairs 21 Cfr Part 11 Lims Software Documentation Risk Management Medical Devices Biopharmaceuticals Computer System Validation Project Management Fmea Trackwise U.s. Food And Drug Administration Quality Improvement Cglp Business Process Mapping Cell Therapy Risk Assessment Cmo Management Process Validation Quality Agreements Ich Q7a Ich Q9 Ich Q10 Iso 9001 Lead Auditor Udi Barcodes Pharmaceuticals Problem Solving Statistical Process Control Sharepoint Labeling Facilitator Training Gxp Cell Therapies Lbp Cmc Microbiome

Phil Carpenter Education Details

  • Central Connecticut State University
    Central Connecticut State University
    Minor 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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