Summary
Work History
Education
Work Availability
Skills
Timeline
Generic
Ronald Karchenes

Ronald Karchenes

South Weymouth,MA

Summary

Track record of leading development of quality improvement systems, and SOPs creation/execution to ensure compliance with ISO, GLP, GMP and GCP regulations and quality criteria. Known for leading overall Quality management functions, including planning, execution, and control. Expertise in auditing pharmaceutical manufacturing, testing, and storage operations. Possess extensive knowledge of global GMP/GLP and good understanding of GCP and regulatory requirements related to pharmaceutical drug and Clinical manufacturing. Strong collaborative nature, with interpersonal, organizational, and communications skills.

Work History

Manager, GxP Audits and Quality Systems Independen

Praxis Medicines
Cambridge , MA
2023.01 - 2023.03

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

Manager, QA Operations

Editas Medicine Inc.
Cambridge , MA
2022.07 - 2023.01

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

Manager of QA Vendor Management

Agenus Inc
Lexington , MA
2021.03 - 2022.07
  • 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

Quality Assurance Auditor

Agenus Inc
Lexington , MA
2016.08 - 2021.03
  • 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

Senior Quality Assurance Specialist

AMAG Pharmaceuticals
Waltham , MA
2012.02 - 2016.08
  • 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

Education

Bachelor of Arts - Biology

Boston University
Boston, MA
05.1983

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Skills

Twenty years of QA Operations experience which includes:

  • Batch record review, release of materials to clinical sites and drug product for commercial distribution.
  • Review and approval of raw materials used for manufacturing.
  • Review and approval of Certificates of Analysis.
  • Oversaw Material Review Board, Change Control, Manufacturing and QC investigations, Deviations, etc.
  • Authored and approved SOPs.
  • Conducted GMP and SOP Training
  • Internal Audits,
  • Working with CMOs, Testing Labs and other external vendors

Ten years of QA Vendor Management experience which includes:

  • Performing external audits
  • Developed and authored all SOPs pertaining to vendor management
  • Developed and kept current the Approved Vendor List
  • Scheduled vendor audits
  • Developed risk management pertaining to vendors
  • Developed vendor relationships

Timeline

Manager, GxP Audits and Quality Systems Independen

Praxis Medicines
2023.01 - 2023.03

Manager, QA Operations

Editas Medicine Inc.
2022.07 - 2023.01

Manager of QA Vendor Management

Agenus Inc
2021.03 - 2022.07

Quality Assurance Auditor

Agenus Inc
2016.08 - 2021.03

Senior Quality Assurance Specialist

AMAG Pharmaceuticals
2012.02 - 2016.08

Bachelor of Arts - Biology

Boston University
Ronald Karchenes