Quality Systems Assurance, IT AUDITOR

In Review

Julian C. Goins Sr Page *of * */*/****

Julian C. Goins Sr,

Professional Summary

Compliance oversight and support for GXP Quality Systems to assure compliance with regulatory requirements, policies and procedures;

Review, provide feedback and approve validation plans, qualification protocols, and validation reports for new computerized systems to assure correctness, consistency, and regulatory compliance of system documentation;

Conduct compliance audits of GXP Quality Systems and report audit findings to management. Support Supplier Management Program by planning, organizing and conducting supplier audits and qualification;

Represent QA in CAPA tracking system for all GXP computerized systems audit observations and risk mitigation to comply with regulatory requirements and policies and procedures;

Manage risk management process for GXP Quality Systems. Represent QA in the development, implementation, remediation and risk mitigation plans to ensure that plans meet or exceed policies, procedures, and regulatory requirements Relevant Experience

Title: GXP Computerized Systems Validation (CSV) Quality Assurance (QA) Company: Black Diamond Therapeutics (BDTX)

Timeframe: August 2021 – present

Responsibilities:

Provide compliance assurance based on FDA 21 CFR 820 Quality System (QS) regulation and 21 CFR 11 Electronic Records and Electronics Signatures (ERES) for all BDTX computerized systems used to support clinical trials such as Interactive Response Technology (IRT) systems, Document Management (DM) systems

Title: Contract Auditor, Clinical Computerized Systems Company: Black Diamond Therapeutics

Timeframe: April 2021 – July 2021

Responsibilities:

Suvoda Audit - Quality System (QS) and Interactive Response Technology (IRT) Montrium Audit – Montrium Connect Computerized System and Quality System Veeva Audit - Quality System, Veeva Vault Electronic Trial Master File (eTMF) and Regulatory Information Management (RIM) Computerized Systems In Review

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Title: GXP Computerized Systems Quality Assurance and Quality Systems Manager Company: UCB, Inc

Timeframe: May 2008 – August 2018

Responsibilities:

1) Chair the U.S. GxP Supplier Review Board (SRB) and drive SRB processes and documentation

2) Manage GxP vendor files, including documented risk assessments, quality agreements and performance metric reports.

3) Provide QA support to routine Quality/ Compliance activities (e.g. change controls, risk assessments, validations), including those related to computerized systems. 4) Manage the GxP vendor screening process for the U.S. Affiliate 5) Develop and maintain the annual U.S. GxP internal and external annual audit schedules. Drive the collection and analysis of key quality metrics and ensure routine QA review of internal quality metrics (e.g. deviations, audits, CAPAs). 6) Contribute to risk assessments and the development of a risk-based audit schedule including conducting risk based audits and risk mitigation. 7) Serve as lead auditor in support of the annual US QA internal and external audits 8) Assist in maintaining a state of inspection preparedness and directly support health authority inspections.

9) Define, review and, approve investigations and corrective and preventive actions (CAPA) of deviations, product complaints, failures and quality related problems. 10) Manage process improvement initiatives for internal Quality Systems and external suppliers Quality Systems.

11) Drive the periodic review and regular evaluations of the U.S. quality systems and procedures to assure consistency with regulations and UCB standards. 12) Manage risk management process for GXP computerized systems 13) Provide feedback on validation plans and approval on validation reports 14) Participate in periodic reviews on computerized systems used at the U.S. Affiliate 15) Establish and maintain an inventory of computerized systems used at the U.S. Affiliate 16) Provide advice and guidance to U.S. QA staff and partners (internal and external) regarding compliance issues, Quality principles and interpretation of regulations. In Review

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Title: Auditor, Global Compliance

Company: UCB

Timeframe: July 2006 – May 2008

Responsibilities:

(1) Plan and conduct compliance audits related to GXP computerized systems and report audit observations and recommendations to management personnel

(2) Communicate effectively, building and maintaining relationships with UCB management, colleagues, external contacts and suppliers to ensure timely and accurate contributions of technical information for GXP business processes

(3) Provide regulatory guidance, expert consultation, technical support and make recommendations to business functional units for compliance, processes and procedures related to GXP computerized systems

Title: Computerized Systems Validation Process Manager Company: UCB, Inc.

Timeframe: Aug 2002 – Aug 2006

Responsibilities:

(1) Identify regulatory and industry trends, analyze and make recommendations regarding the quality process for computerized systems by providing regulatory guidance and technical support based on knowledge of current regulatory issues and communicating that knowledge to colleagues

(2) Establish annual audit plan, schedule audits of external suppliers of computer systems in a regulated environment and conduct audits of external suppliers.

(3) Review and approve GXP computerized systems validation plans, qualification plans, systems documentation, and validation summary reports Education Profile

Name: Strayer University – Master of Business Administration (MBA) 2008 - 2011 Name: Information Systems Audit and Control Association (ISACA) Certified Information Security Manager (CISM) Year(s): 2004-2005 Name: Information Systems Audit and Control Association (ISACA) Certified Information Systems Auditor (CISA) Year(s): 2003 – 2004 Name: Microsoft Certified Systems Engineer Year(s): 2001 – 2002 Name: Strayer University - Bachelor of Science in Computer Information System (BSCIS) Year(s): 1993 – 1996

In Review

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