Ronald Karchenes

Worked with 3rd party auditors to schedule audits of Praxis vendors.

Reviewed and approved audit Agendas

Reviewed Audit responses.

Entered external audit reports into vendor approval life cycle in Veeva

Vendors included GLP, GCP and GMP vendors

Oversaw risk-based quality auditing of Praxis vendors

Act as a contact point for all audit-related issues

Issued Batch Records to Manufacturing

Review and disposition of executed batch records

Inspection and release of patient apheresis to Manufacturing

Used Veeva to initiate and approve QMS records

• Track and manage quality of over 300 GMP, GLP, GCP, and ISO-regulated global vendors contracted by company.
• Enforce implementation of regulated clinical and commercial processes to fulfill compliance requirements.
• Provide effective leadership to cross-functional departments and coordinate multi-discipline project groups.
• Ensured compliance with company quality standards by conducting vendor and product evaluations.
• Supported senior management in informed decision-making by communicating KPIs and responding to queries.
• Cultivated and maintained working relationships with stakeholders and management team at all corporate levels.
• Quality management of 300+ GMP, GLP, GCP and ISO regulated global vendors used by the company. Quality management of 300+ GMP, GLP, GCP and ISO regulated global vendors used by the company.

Skills:
Biopharmaceuticals, Contract Manufacturing, ICH, cGMP manufacturing, ISO 9001, ISO 13485, Good Distribution Practice (GDP), Data Integrity, 21 CFR Part 11, 21 CFR Part 210/211, Change Control, Compliance Regulations, Corrective and Preventive Action (CAPA), Standard Operating Procedure (SOP), Master Control, SharePoint, SmartSheet, Project Management, Time Management, Organization Skills, Team Management, Cross-functional Team Leadership, Veeva, Microsoft 365 Suite, FDA Bioresearch Monitoring Information (BIMO), Master Control

• Performed audits of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) at national as well as international contract research/testing laboratories.
• Evaluated quality agreements and approved clinical trial CROs. Collected, compiled, and presented audit findings to relevant personnel in detailed reports.
• Initiated and coordinated several Internal audits, while implementing GMP regulations.
• Devised and enforced Standard Operating Procedures (SOPs) to ensure operational compliance with regulations.
• Established and directed corporate vendor management program for two Agenus facilities, including Lexington, MA and Berkeley CA.
• Oversaw practice recalls twice a year

• Ensured quality drug product disposition across commercial markets and clinical trial sites by planning, coordinating, and leading several QA inspections.
• Drafted product annual reports. Led quality investigations, reviewed deviations, and administered change controls. Established and maintained positive working relationships with CMOs, CROs, Testing Labs and management team.
• Reviewed and approved transfer-validated QC assays and authenticated production processes.
• Devised and executed process validation and regulatory procedures for commercial drug manufacturing.
• Aligned quality processes with company policies and compliance requirements collaborating with new Contract Manufacturing Organizations (CMOs) and AMAG leadership team.
• Ensured end-product meet defined quality criteria by auditing CMOs and CROs.
• Complaint Investigations
• Assisted in conducting Product Reviews and Quality Metrics