Phil Carpenter Email & Phone Number

Boston, Massachusetts, Us

Tokyo, Jp

Department Name Change

Tokyo, Jp

Cambridge, Ma, Us

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

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

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

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

• 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

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