Quality Assurance Senior

Rufus E. Williams, Jr.

**** ****** **** *****

Unit# 218

Dublin, California 94568

*****.*********@*****.*** 909-***-**** (cell)

Quality & Manufacturing Management Leader with experience supporting Global Pharmaceutical and Biotechnology Industries. Expertise managing plant startup operations and technical engineering projects including Commissioning, Validation Qualifications (IQ/OQ/PQ), Cleaning, Maintenance, Manufacturing, Quality, and Compliance Investigations, Deviations, CAPA, Change Control. Process improvement knowledge and experience in implementing and driving a continuous improvement culture through mentoring and professional development.

CORE COMPENTENCIES

●Investigations & CAPA, Deviations

●Aseptic/Sterile Processing/ Compounding

●Root Cause Analysis

●Formulation & Compounding

●Six Sigma / Lean Methodologies

●Change Control

●Track Wise

●GMP/ Regulatory Guidance

●Technical Writing

●Non-Conformance, Complaints, Audits

●Solid Dose Packaging

●Quality Systems, 21 CFR 210 & 211

●Regulatory Compliance / Inspections

●Facilities, Water Systems, WFI, RODI

●Process, Equipment/ Product Quality

●Batch Record Review

●Veeva Document Management/ SOP

●Cell Gene Therapies

Professional Experience

Kolon Tissue Gene, Rockville, Maryland-June 2024-December 2024 ( AD HOC)

Senior Quality Assurance Specialist (Consultant)

Provided recommendations for implementation of a Quality System Management Instructure

Successfully completed the remediation/ closure of a large volume of Standard Operating Procedures / Policies as identified by the client

Completed a Gap Analysis of the standard operating procedures versus the QSM

Provided the strategic remedial path to address gaps within the documentation system

BioMerieux, San Jose, California-June 2023-November 2024

Senior Quality Assurance Specialist (Consultant)

Experience with IVD ( In-Vitro Diagnostics) Medical Device Equipment

Functioned as the Remediation Project Manager for compliance gaps

Successfully completed the remediation/ closure of a large volume of out of compliance records

Actively worked on the closure of a non-compliant JIRA record platform

Examined and interpreted medical device records to ensure accuracy

Coordinated the company’s departments to provide guidance on compliance issues

Remediation project for Quality Events, Cause Investigations, Change Control, Risk Assessments

Novavax, Gaithersburg, Maryland-December 2022-January 2024

QMD Doc Support Contractor

Fully knowledgeable in Cell Gene Therapy

Administered document system to access and revision control to ensure clarity and accuracy of documents utilizing the EDMS system

Supported the document revisions to the Pre-Filled Syringe Quality Initiative utilizing a Gap Analysis approach

Participated in the planning and success implementation of special request made by Management including specific information need such as to extract information into an appropriate Quality Share Point

Revised all GXP documents, such as Standard Operating Procedures, Specifications, CAPAS, Deviations and Change Control from a technical writing perspective.

Coordinated the company’s departments to provide alignment on procedures

Developed the shipping validation protocols

Seres Therapeutics, Cambridge Massachusetts, March 2022-December 2022

Senior Quality Assurance Specialist ( Consultant)

Acted a Project Manager to eliminate a large back log of quality initiatives ( CAPA & Deviations)

Acted a liaison for the project sponsor to conduct meeting and coordinate all activities of the project

Authored the closure documents for CAPA and Deviation quality initiatives

Achieved a 98% closure rate for CAPA; Achieved a 96-closure rate for deviations

Trained site personnel on the SOPs related to closure and provided GMP guidance when required.

Moderna-Bloomington, Indiana December- 2020- March 2022

Senior Quality Assurance Batch Record Reviewer (Consultant)

Acted a member of start-up operations and developed the business model for the team operations

Performed a comprehensive batch record review for the Packaging Operations

Performed an assessment/ evaluation of all applicable deviations for root cause and closure

Identified operational interventions and offered a resolution for remediation of compliance issues

Developed training module for new team members

Immunomedics/Gilead- Morris Plains, New Jersey- August 2019- September 2021

Quality Compliance Engineer (Consultant)

Fully knowledgeable in Cell Gene Therapy in Upstream and Downstream Operations

Quality Compliance Engineer in support of CAPA initiatives for the Validation Team

Develop and maintain departmental metrics for Compliance and FDA Readiness

Experience with the Upstream and Downstream manufacturing of monoclonal antibodies

Focal point of contact for all Compliance Initiatives/ Internal Audits for the Validation Team

Authored and assisted in the execution/ closure of Change Controls and Validation Protocols

Conducted gap analysis for all validation efforts to identify gaps in the validation strategy

Project Leader for Continuous Process Verification using Statistical Process Control, SPC

Co Authored the Quarterly CPV report which analyzed the statistical process performance from a perspective of CPP,KPP and Provisional Limits

Wrote all Technical Investigations for the Validation Team using Root Cause Analysis Methodologies

Novartis- Morris Plains, New Jersey- January 2019- July 2019

Quality Compliance Investigator (Consultant)

Experienced Knowledge of Car T / Gene Cell Therapy Processes / Bioreactors/

Triaged operational procedural deviations for T-Cell Manufacturing Processes and authored the entire deviation report which includes root cause analysis

Quality Compliance Investigator in support of manufacturing operational deviations through direct observation and review of processes

Participate in cross functional team to identify effective corrective and preventative actions to improve process quality

Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures

Authored and managed multiple deviations to closure using Root Cause Methodologies, (5-Whys, Fishbone, Failure Mode, and Effects Analysis

Lead Facilitator for Investigations, CAPA and Impact Assessments using Root Cause Analysis Methodologies

Pfizer -Kalamazoo, Michigan – August 2018- January 2019

Quality Operations Professional (Consultant)

Provide Quality floor support for all GMP Packaging operations

Project Leader for all Sterile & Non-Sterile Investigations, CAPA and Impact Assessments using Root Cause Analysis Methodologies

Triage operational procedural deviations/ Sterile & Non-Sterile Packaging

Performed Batch Record review for process variations, sterility results, analytical results prior to release

Dispositioned batch status, hold, release, impact analysis in accordance with GMP/ Regulatory guidance

Certified in the use of Trackwise for all Quality Initiatives

Intarcia Therapeutics - Hayward, California – July 2017- August 2018

Quality Compliance Engineer (Consultant)

Project Leader for Regulatory Compliance Initiative/ Instrument Risk Assessment

Project Leader for Facilities Equipment Gap Analysis

Initiated Change Controls for Equipment Modifications

Project Leader for all Facility Investigations, CAPA and Impact Assessments using Root Cause Analysis Methodologies

Monitored the PM/CAL program for GMP compliance or addressing Out of Tolerance, OOT

Review Analytical data on equipment calibration and readiness

Project Team member for Facility PM/CAL program and address any tolerance issues (OOT)

Project Team member for Maximo Asset Management Standard Operating Procedures/ Business Administration

Facilities Team representative for Sterility Investigation Impact Assessment on all facility assets

Authored Standard Operating Procedures/ Technical documents/ Equipment specifications using the Intarcia’s Electronic Management System, Veeva

Dr. Reddy’s - Shreveport, Louisiana – January 2015- May2017

Operations Manager for Oral Solid Dose

Managed twelve employees responsible for the Coating, Printing & Packaging Operations

Ensured adherence to all FDA guidelines and regulatory compliance

Project leader for the implementation of automated CIP (clean in place) which increased productivity by 50%

CMO/weekly audits of GMP operational procedures, compliance and regulatory

Completed gap analysis of training requirements and addressed deficiencies within a 90-day period

Exceeded the goal of $1.4 M in profit for the budgetary years

Conducted quality investigations/ product impact/CAPA

Project leader for the implementation of new transfer pumps which increased productivity by 70%

Neutrogena/Johnson & Johnson – Los Angeles, California – July 2014- December 2014

Consultant/Compounding Investigations/CAPA/Compliance

Prepared and completed technical investigations based on deviations in the SOP’s /Batch Record Requirements

Wrote and revised Standard Operating Procedures (SOP’s) for the manufacturing departments in adherence with GMP guidance.

Identified and addressed all issues with equipment validation discrepancies

Conducted gap analysis for the manufacturing team to identify employee training deficiencies

Developed the departmental training curriculum

Focused on training & certification of employees which addressed issues relating to nonconforming FDA/GMP requirements in job functions

Avrio Biopharma (CMO) - Irvine, California – January 2014– July 2014

Aseptic Manufacturing Manager

Management of projects related to aseptic filling processing, which included Clean Room Management, Autoclave Operations, and Lyophilization

Validated a new sterile filling suite and classified all rooms within the ISO 5 sterile filling suite

Validated a new state of the art filling machine which included the Factory & Site Acceptance Testing

Successful completion of filling validation process/media fills

Trained and certified all operators on Aseptic Gowning

Developed and implemented new batch records for all CMO’s

Developed the clean room management program

Gilead Sciences Incorporated - San Dimas, California – July 2006– December 2013

Aseptic Manufacturing Manager of Aseptic Sterile Filling/Packaging/ Compounding

Managed a team related to aseptic filling processing which included Clean Room Management, Autoclave Operations and Lyophilization

Developed a training gap analysis to improve compliance.

Responsible for all solid dose filling activities from filling to packaging, focusing label recognition and efficiency using OEE

Accomplished the commissioning and implementation of a new solid dose packaging line on second shift

Exceeded the production plan in each of the three years under my management

Annual recipient of the “Values of Work Award” based on my contribution in teamwork, excellence, accountability, and FDA readiness

Co-managed a $10M operating budget, meeting the corporate target of 3% reduction

Launched three new solid dose products and one parenteral product

Worked with third party for the development of the filling process of (3) phase II clinical products, CMO

Developed the clean room management program

Reviewed batch record analytical data, signature approval

Developed the SOP procedures for product containment of a sensitizer within the facility; developed the conversion process by which we converted from manufacturing a cytotoxic product to sensitizer

Annually implemented over $100K in cost reductions collaborating with external vendors

Sponsored the $15M scale-up project for the aseptic facility

DFB Biotech - Curacao, Netherland Antilles – January 2003- July 2006

Director of Manufacturing

Plant oversite Director for Manufacturing, Maintenance, Quality, Purchasing and Validation departments

Experience with Biological Fermentations, Cell Culture, Cell Bank

Main point of contact for FDA regulatory inspections

Member of the DFB Biotech Board of Directors as the liaison for the Dutch government

Developed robust efficiency plans increasing productivity annually by 15%

Developed remediation efforts for FDA audit removing regulatory restrictions

Implemented engineering programs that improved equipment readiness and reliability

Developed the yearly manufacturing projections to meet sales requirements based on customer demand

Tyco Healthcare - Raleigh, North Carolina – April 2001– August 2002

Manufacturing Manager Filling and Packaging

Managed three shift terminally sterilized filling and packaging operation

Project Leader of automation vision system for packing line; cost reduction initiative

Provided leadership to all staff in the areas of manufacturing, cGMP’s, and FDA regulations

Reduced labor, material, and operator deviations by 70%

Managed a $1M budget

Hoffmann La Roche - Totowa, New Jersey – January 2000– April 2001

Aseptic Manufacturing Manager of Aseptic Sterile Filling, Packaging, and Maintenance

Managed a three-shift operation consisting of both maintenance and production staff

Implemented an automated filter integrity tester/quality initiative

Maintained the #1 rated factory from a labor performance and customer service perspective

Managed an $18M budget

Operations Manager of the liquids/oral dosage department

Cross trained in encapsulation and granulation operations

Virally Inactive Technologies - Melville, New York – July 1997– December 1999

Manager of Aseptic/ Sterile Filling and Packaging

Managed the facility start-up through final FDA approval, including staffing and writing departmental SOP

Validated the Sterile Filling Process Equipment

Developed and managed a $4M budget

Researched vendor pricing for start-up operations and participated in all negotiations

Worked with PLC’s, Clean in Place (CIP), Steam Sterilization operating systems

Validated the following systems: Media fills and conformance batches, Aseptic /Sterile Filling Machine’s installation

Completed the Performance Qualification, Steam Sterilization Cycles, Autoclave Cycle, Gowning.

Developed the Clean Room Management protocols

EDUCATION & CREDENTIALS

United States Army, Captain, Honorable Discharge

Bachelor of Science in Biology – North Carolina A&T State University, Greensboro, North Carolina

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