1. 1063 Treadstone Lane
Powder Springs, GA 30127
Mobile (678) 787-7903
gc_clark@hotmail.com
Page 1 of 5
Geoffrey C. Clark
Focused, dynamic and goal oriented Quality professional with 16+ years experience related to GXP
Quality Systems from both a functional and a process development standpoint. Enthusiastic and proficient at
developing best practices, organizational improvements and system enhancements. Proactively seeks to
identify areas of process improvement and unrealized efficiencies with an emphasis on communicating core
vision to applicable stakeholders. Seeks to mentor and coach reports for the purposes of improving and
expanding skill sets, their value to the organization and to facilitate positive morale and retention.
Experience
Dendreon Pharmaceuticals (formerly Dendreon Corporation) Union City, Georgia
QA Manager (Quality Project Manager, Integration Leader) March 2016 - Present
 Tasked with leading the company’s Quality System Integration project related to compliance between
Dendreon procedures and Valeant Quality Elements for each 26 applicable Directives. Entails the
coordination and leadership of 26 separate element teams, cross-site and cross-function, as appropriate,
as well as the related reporting of metrics and executive summaries.
 Owner and developer of the company’s Cost of Quality (CoQ) program, including weekly, monthly, and
annual tracking and trending of the cost of non-conformance as well as the identification and analysis of
cost savings initiatives as it relates to quality activities.
 Owner and developer of the company’s risk management program, in compliance with Valeant Directives.
This includes the creation of a FMEA (Failures Modes & Effects Analysis) matrix for assessing risk to
product and process as well as ancillary and related support functions and activities (work in progress).
 Key Achievements include:
 Successful completion (96% final grade) of the Essential of Project Management certification class
through Villanova University. Certification exam via PMI.org to be scheduled.
 Development and implementation of the site’s Cost of Quality program and tracking/trending
spreadsheet. This includes tracking cost improvement projects to exceed the functional QPI of >0.2%
cost reduction of site budget (Metric currently exceeded). Additionally, through the weekly identification
and trending of process and product non-conformances to track and trend deviation and their impact to
our bill of material costs and our standard costs as a factor of units manufactured.
 Development and implementation of company’s QSE (Quality System Element) project, including
tracking and coordinating of gap assessments, procedural updates, maintenance of the governing
CAPA, as well as the creation and routine update of the projects status tracker and flash reports.
QA Manager (Quality Systems) June 2014 – March 2016
 Provides managerial oversight and leadership for a team of 13 supervisors and associates covering the
following functional programs and systems within the quality organization:
 Document Management
 Change Control
 Records Management
 GMP Training
 Quality on the Floor
 Validation
 Process Monitoring
This includes activities associated with:
 Hiring and management of Quality Assurance staff that covers multiple work shifts.
 Review and approval of GMP controlled documents including SOPs.

2. 1063 Treadstone Lane
Powder Springs, GA 30127
Mobile (678) 787-7903
gc_clark@hotmail.com
Page 2 of 5
 Leading and participating on cross-functional project teams, representing the Quality unit.
 Providing strategic leadership, prioritization, communication, and development for all reports.
 The development of short and long term department goals and the subsequent review of employee
performance on a regular basis.
 Participate in the development and generation of the Annual Product Review.
 Generation and presentation of metrics and reports to senior and executive management.
 Delivery of training including eSystem and Annual GMP refresher tutorials.
 Provide support during Regulatory Inspections
 Key achievements include:
 The leadership and coordination of the Document Management remediation team operating under the
auspices of the Dendreon Quality Systems Assessment project, driven as a deliverable to FDA. This
includes the assessment and recommendation of key configuration changes to the company’s EDMS
and the coordination and negotiation with the related vendor, the consolidation and streamlining of all
functional procedures, the creation of a system Quality Policy, and the development of a lifecycle
process for the Quality Manual, detailing the document hierarchy.
 Business lead for the rollout of the Documentum based GDMS system at all Dendreon sites, including
the validated mapping and migration of all pertinent files and data, and the subsequent
decommissioning of the defunct FDQM system. This includes review and approval of all applicable
validation documents (Mapping Specifications, PQs, Executable Protocols, Final Reports) and business
procedures, as well as responsibility for the coordination of protocol executions, organizational
communication, and training deliverables.
 Business lead for the system configuration and rollout of batch record controlled printing functionality
within the GDSM system, allowing for automated lot number application by barcode scanner. This
includes review and approval of all applicable validation documents and business procedures, as well
as responsibility for the coordination of protocol executions, organizational communication, and training
deliverables.
 Developed and configured process flow and ultimately rolled out training proficiencies within
Documentum for production use.
 War Room manager for audits, internal and by regulatory agency, managing the distribution and
reconciliation of RFIs (requests for information) in a timely fashion.
 Provided managerial oversight and strategic leadership for the successful business rollouts of the
Compliance Wire LMS (Learning Management System) and Kintana (Change Control) electronic
systems for use at the Union City IMF.
 Developed customized document management process to be controlled via protocol for the support of
the company’s automated manufacturing R&D activities.
 Conducted analysis of business processes within my purview for the purposes of identifying areas for
efficiencies and cost reduction opportunities. Realized a savings of approximately $3900 per
employee.
Additional Ancillary Experience
 Served as site head of safety committee tasked with evaluating and recommending safety improvements to
the facility EHS department. This included the lead and coordination of the company health fair.

3. 1063 Treadstone Lane
Powder Springs, GA 30127
Mobile (678) 787-7903
gc_clark@hotmail.com
Page 3 of 5
Dendreon Pharmaceuticals (formerly Dendreon Corporation) Union City, Georgia
QA Document Management & Change Control Supervisor November 2010 – June 2014
 Provides daily supervision of operations to maintain Quality and Change Control master files ensuring
compliance with regulatory requirements, which may include:
 Review and revision of procedures, specifications and forms.
 Updates to logs, databases, catalogues and matrices.
 Document control, records management, and change control process improvements.
 Preparation of status reports.
 Conducts training of department processes and electronic document management systems.
 Assists with compiling regulatory filing documents and maintaining computerized files to support all
documentation systems.
 Represents department in cross functional teams and projects.
 Participant and lead in the development of standards and procedures for maintaining document control,
change control, and records management.
 Selects, develops and evaluates personnel to ensure functional objectives are met.
 Key achievements include:
 Successfully lead the site rollout for the Documentum based FDQM (FirstDoc Quality & Manufacturing)
system including scheduling of training activities, communication and trouble-shooting.
 Lead and coordinated the project for the decommissioning of the legacy eDocs document management
system.
 Developed and implemented process flow for the efficient data consolidation and closure of commercial
and clinical batch records.
 Developed the protocol and coordinated the execution of a manual inventory of all batch records
executed at the company’s New Jersey manufacturing facility following divestiture for the purposes of
effective archival.
 Performed as Doc Control prep room liaison for all internal and external site audits. Includes acting as
Doc Control SME during successful conversations with all auditors, including FDA, resulting in no
functional observations.
 Performed successful audit of archival vendor, Recall, resulting in company acceptance as an
approved vendor for records management purposes.
 Implemented new doctypes withing FDQM: Environmental Monitoring Monthly Reports & Laboratory
Investigation Trends Quarterly Reports
Note: November 2011, in addition to performing supervisor function, manufacturing facility, also assumed
the role of supervisor, corporate Document Control and system owner for corporate EDMS.
Note: December 2012, assumed supervisory responsibilities for the Change Control function in addition to
Document & Records Management

4. 1063 Treadstone Lane
Powder Springs, GA 30127
Mobile (678) 787-7903
gc_clark@hotmail.com
Page 4 of 5
Abbott Products, Inc. (formerly Solvay Pharmaceuticals, Inc.) Marietta, Georgia
Quality Systems Specialist June 2001 – October 2010
 Business Administrator for the Solvay Pharmaceuticals Documentum system (SOLID). Job requirements
include problem resolution, user account management, development and execution of training material,
development and execution of validation documentation for system updates and modifications,
communications, and general system support.
 Leader and participant on project teams (local and global) tasked with such deliverables as the
development and release of new electronic systems, system upgrades, and document systems. Regularly
consulted by others for advice on process improvements.
 Responsible for the business administration of the quality systems tracking software (SolTraqs) with
regards to the processing and review of records involved in the change control, discrepancies, planned
deviations, and product quality complaint areas. This also includes the development and execution of both
training material and validation documentation.
 Tasked with the responsibility of system harmonization across multiple sites necessitating the coordination
and routine consultation with global colleagues.
 Responsible for the business management, review, and processing of the following document types which
support the developmental, clinical and marketed product activities within the company:
 Standard Operating Procedures (Local and Global)
 Company Procedures
 SOP Forms
 Specifications and Test Methods (including bioanalytical test methods)
 Master Manufacturing Records (for clinical materials)
 Acceptable Quality Level (AQL) Sheets (for release of marketed product)
 Facility Requirements
 Contract Manufacturing documents (for version control)
 Material Safety Data Sheets (for version control)
 Validation Documents
 Coordinate the timely periodic review of SOPs / Company Procedures so as to ensure compliance with
applicable GXP regulations and industry standards.
 Developed, authored, and implemented departmental and global SOPs supporting GXP activities.
 Responsible for employee training related to electronic system usage, document workflows, good
documentation practices, and the development and release of electronic tutorials.
 Developed and implemented departmental user tools including a Quality Systems webpage and “frequently
asked questions” cards for pertinent electronic systems.
 Generate reports and provide statistical information to management as requested or required.
 Auditor of company periodic review accountabilities and controlled copy manuals.
Additional Relevant Experience
 Performed duties as an administrator within the I-Site (Solvay’s website for fostering innovation) including
trouble shooting, user profile management, general system maintenance, and routine updates.

5. 1063 Treadstone Lane
Powder Springs, GA 30127
Mobile (678) 787-7903
gc_clark@hotmail.com
Page 5 of 5
 Performed on-site GMP qualification audits of vendors in use by Solvay Pharmaceuticals, Inc. for the
purpose of ensuring compliance to appropriate quality systems.
Education
University of Georgia, Terry College of Business
Bachelor of Business Administration, Finance
Villanova University
Essentials of Project Management
Computer Skills
Proficient in Microsoft Office Products
Experienced super-user in Documentum and TrackWise software packages
Hobbies/Interests
Passionate amateur in home improvement. Over the course of two homes owned, successfully completed the
following projects:
 Laid wood floors at both homes (laminate & engineered hardwood)
 Installed wainscoting and bead-board through several rooms
 Installed tile floor in laundry room
 Installed board & batten wall in dining room
 Completely updated all light fixtures in current home
 Updated and changed out all door fixtures, including knobs and hinges for all interior and exterior doors at
both homes
 Installed and stained new stair treads
 Installed baseboard, quarter round, and crown molding
 Created additional shelving for several closets
 Installed new door chimes
 Completely repainted every interior room and hallway of both homes.
Love of reading, in particular, Stephen King and George RR Martin are some of my favorites.
Passionate football fan; Go Dawgs!
Lastly, but most importantly, very lucky and blessed husband and father to a loving wife and amazing little girl.