John (Jay) Beaver, Ms Email & Phone Number

Lake Zurich, Il, Us

Lake Zurich, Illinois, United States

Support the GCP QA function by executing GCP QA activities related to clinical product development and clinical studies. Interact cross-functionally to provide GCP and compliance support for ongoing and new clinical studies led by the clinical team, assist with managemenet of local QMS and processes while ensuring compliance with corporate requirements as well as US and EU GCP regulations and guidelines.

Assist in the establishment of the EQRx Quality Management System (QMS) for the GCP program. Key contributor in GCP CAPA and quality issues to ensure compliance with health authority regulations (FDA, EMA, MHRA, etc.). Serve as GCP Lead for the planning, execution, and effectiveness of the GCP audit program for two major clinical programs.- Assisted in MHRA responses to GCP and GLP questions regarding a submission.- Buffered the GLP QA program for 6 months until a new candidate was hired.- Obtained an EU legal representative certificate per regulation EU No. 536/2014.

Oversee vendor and internal audit management to foster and grow the audit and oversight programs. Which includes defining risk management and audit management approaches for both vendors and Internal Audits.- Demonstrated leadership and analytical thinking provides thought leadership (influence without authority) on abstract ideas and situations across multiple functional areas of the business and external CRO stakeholders to resolve challenging vendor and internal issues.- Provides leadership and elevates the internal audit program and vendor oversight function within the R&D Quality organization to the next level.

Responsible for ensuring that clinical trial activities for assigned clinical development programs are conducted in compliance with applicable regulations, ICH Good Clinical Practice Guidelines, and internal policies and procedures. In addition, is responsible for ensuring that investigator sites, external vendors, and internal processes meet quality standards and accurately identifying and developing action plans to mitigate compliance risks. Also leads domestic and international audits of clinical investigator sites, documents, databases, vendors, and internal systems to assure compliance with applicable regulations, ICH GCP and internal procedures.

Lead Issue Escalation meetings for serious clinical compliance issues. Compliance contact for clinical consultations. Manage deviations/exceptions and associated corrective and preventive actions (CAPA) for global programs utilizing TrackWise. Lead QA audit observation responses and remediation for GxP QA audits. Participate in the readiness and hosting of regulatory inspections.Accomplishments:• Revised the investigational product (IP) process and associated standard operating procedures.• Created a due diligence document which summarizes all GMP & GCP CAPAs conducted for expired IP non-conformances for internal FDA/MHRA inspection readiness.• Participated in preparation and hosting three (3) FDA inspections and a MHRA inspection.

Bs, Biology

Quality Management

Education record

Master Of Science - Ms, Food Science

Education record

Ms, Food Science