Experienced Pharmaceutical Project & Quality Lead

Christopher A Shaw

**** * ***** **., *********, Kansas 67460

Tel: 620-***-**** / E-mail: *************@*****.***

CAREER PROFILE

An Experienced Professional with over 19 years of progressive experience in the Pharmaceutical industry. Experienced in Project Management, Quality On The Floor, cGMP, CAPA, SOP, Work Instruction, and Technical Document creation editing and review, Validation (formulation through shipping), Computer System Validation (CSV), Customer/Partner Relationship Management, Analytical Analysis, Process Mapping, 21CFR Part 11 remediation and GAMP5, Six Sigma, People Management, Process Improvement, Issue Resolution and Strategic Planning. Sound knowledge of industry cGMP, Quality, Validation, and Regulatory functions for Small Molecule and Biologic Sterile Manufacturing. Proven ability to function as a liaison between Contract Manufacturing Partners and Quality and Production operations in a manufacturing facility.

•Built a Quality Management System (CMS) for the Validation process and supporting functions at Fagron. Developing Quality Master Plans, Standard Operating Procedures, and protocols for implementation of new systems and support of current quality systems.

•Remediation of QMS, SOPs, and site and global policies for Hospira/Pfizer related to 21CFR Part 11 and GAMP5 to ensure Data Integrity and ALCOA principals are aligned with regulatory and corporate requirements.

•Proficient with TrackWise Global Quality Tracking System (gQTS) as the Quality Management System (QMS) for Change Management, Corrective and Preventive Action (CAPA), Change Management and Investigation processes and procedures for deviation support.

Creative and intuitive thinker with effective technical writing, project management and goal setting abilities combined with, communication, interpersonal, leadership, and presentation skills. Self-motivated with the ability to excel in a fast-paced environment; communicate effectively at all levels; manage competing priorities; and adapt readily to new challenges.

ACCOMPLISHMENTS

Quality Operations Professional – i-Pharm Consulting

•First point of contact for quality for day-to-day manufacturing operations. Review, revision, and creation of Standard Operating Procedures, Work Instructions, and technical summaries.

•Quality on the floor oversite of manufacturing operations at the Pfizer, McPherson, Kansas site for vaccine production. Resolution and management of quality prevention and impact reduction for the compounding/formulation, filling, automated visual inspection, packaging, and vaccine storage operations.

•Key contributor for prevention, reduction, and resolution for critical process checks performed during manufacturing. Deviation support including performance of colleague interviews and content input using evidence supported data for no impact or impact mitigation.

Senior Validation Engineer – PFIZER, Inc.

•Worked closely with consultant and contract professionals to create, execute, review, and approve protocols for validation of packaging integrity, serialization and shipping activities at the McPherson site.

•Remediation of Standard Operating Procedures and Validation Protocols in response to internal and external audits and for 21CFR Part 11 and GAMP 5 CSV remediation.

•Oversight support of consultant and contract professionals.

Validation Manager – FAGRON STERILE SERVICES / JCB LABORATORIES

•Established Validation department roles and responsibilities for Wichita facilities.

•Eliminated backlog of open and aging validation protocols and reports for completed activities.

•Created initial Standard Operating Procedures, risk assessments, technical document summaries and Validation Project Plan for new Enterprise Resource Planning software for facilities.

•Developed Process Validation plan for first automated vial filling line, incorporating aseptic process simulation, room time, max/min personnel occupancy, personnel gowning time, bulk hold time, mixing time, and fill uniformity.

Customer Quality Engineer Supervisor – HOSPIRA, Inc.

•Helped create initial structure of the Customer Quality organization at the Hospira, McPherson facility, adding dedicated quality support for the One2One partners.

•Review, creation, and approval of quality and technical documentation in support of CMO activities such as Quality Agreements, SOPs, and Change Management.

•Worked diligently with One2One partners to launch a record-breaking number of new medicines in 2014.

PROFESSIONAL EXPERIENCE

TEKsystems Consulting; Elanco, Elwood, Kansas NOV 2024 – MAR 2025

Quality Assurance – Contract Consultant

Develop theory and content of validation documents and reports for existing and new equipment and laboratory instrumentation. Creation, revision, review, and approval of Standard Operating Procedures, Work Instructions, and technical documents for process mapping and improvement. Project plans, protocols, and report authoring, review, and approval. Review and facilitate changes and on-going review and revalidation to ensure that validation documentation is compliant with ALCOA, DATA Integrity and Plant and Corporate validation requirements and policies, as well as with regulatory expectations.

•Work closely with validation change owners from Engineering and Manufacturing to plan and draft validation documents and assure proper execution/documentation of test results. Ensure adherence to current guidance and regulations for Data Integrity and ALCOA industry guidance.

•Ensure validation documentation is in compliance with Plant and Corporate policies and procedures; Ensured validation packages contain all relevant information, rationales, references, and data.

•Write and/or assist with the writing of Validation Master Plans. Write and assist with the writing of Standard Operating Procedures. Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.

•Assist with the remediation, review or revalidation of existing manufacturing process validation, cleaning validation, plant equipment/facilities/utilities/control systems/software, computer system validation (CSV).

BioPoint Consulting; Vertex, Boston MA Site NOV 2022 – JAN 2024

Commercial Manufacturing and Supply Chain Project Manager – Contract Consultant

Project management of commercial and development projects within the CMSC (Commercial Manufacturing and Supply Chain) group and management of Change Control activities. Origination, review, and follow through to completion for project charters, timelines, kick-off meetings, and lessons learned. Organize and lead functional project teams. Coordination with other functional groups to ensure projects meet organizational goals and milestones.

•Key point of contact for all project goals and milestones; point of contact for CMO partners.

•Organize and coordinate meetings with cross functional groups during kick-off and through life cycle of projects.

•Ensuring Vertex company principles followed in project plan and deliverables creation for all projects.

•Work with cross-functional teams to problem solve and escalate issues as appropriate and support risk-based assessments related to project deliverables and requirements.

•Deviation support by providing input on path forward and collaboration for initial event description and data gathering real time.

•Utilize Microsoft Office suite of applications for project planning, tracking, and technical document creation, review and approval.

The Judge Group Consulting; Takeda Lexington, MA Site APR 2022 – AUG 2022

Compliance Project Manager – Contract Consultant

Project management of Change Control and Corrective and Preventive Action plans/records for the BioMass sites. Origination, review, and follow through to completion for records. Coordination with other functional groups to ensure CR and CAPA records have appropriate evaluation and functional assessments and adhere to ALCOA+ Data Integrity requirements..

•Key point of contact for all CR and CAPA records created by myself and in my ownership.

•Organize and coordinate meetings with cross functional groups during kick-off and through life cycle of CR and CAPA projects/records.

•Ensuring ALCOA+ and Data Integrity principles followed in project plan and deliverable creation for EBR implementation project.

•Work with cross-functional teams to problem solve and escalate issues as appropriate and support risk-based assessments related to CR and CAPA requirements.

•Deviation support by providing input on path forward and collaboration for initial event description and data gathering real time using ALCOA principles.

•Utilize TrackWise Global Quality Tracking System (gQTS) as the Quality Management System (QMS) for Change Management, CAPA, Change and deviation support.

i-Pharm Consulting, Pfizer McPherson Site JUN 2021 – JAN 2022

Quality Operations Professional (Quality Engineer) – Contract Consultant

Quality on the floor oversite of manufacturing operations at the Pfizer, McPherson Kansas site for vaccine production. Resolution and management of quality prevention and impact reduction for the filling, automated visual inspection, and packaging operations. Prevention, reduction, and resolution for critical process checks performed during manufacturing to ensure Data Integrity is maintained in all aspects of the manufacturing and packaging processes. Deviation support including performance of colleague interviews and content input using evidence supported data for no impact or impact mitigation.

•Key point of contact for all Quality concerns or issues for the vaccine compounding/formulation, filling, automated visual inspection, packaging, and vaccine storage operations. On the manufacturing floor providing real time quality support for vaccine manufacturing processes from receipt through shipping.

•Initiation and development of project plan for continuous improvement of quality systems to support vaccine manufacturing and prevention of deviations and to improve CAPA initiation and resolutions; including creation of technical documentation supporting proposal of process improvement mapping.

•Subject Matter Expert for the vaccine specific processes. Oversight of process critical checks and documentation in order to prevent even occurrence and mitigate impact of events when they occur.

Work with cross-functional teams to problem solve and escalate issues as appropriate and support risk-based assessments related to vaccine production.

Deviation support by providing input on path forward and collaboration for initial event description and data gathering real time using ALCOA principles.

•Utilize TrackWise Global Quality Tracking System (gQTS) as the Quality Management System (QMS) for Investigations, CAPA, Change Management and Notification to Management.

•Support of other manufacturing areas when vaccine processes are not running.

•Review and creation of quality documentation in support of vaccine operations and other manufacturing operations as needed. Driver for project plan creation and continuous improvement initiatives for areas of oversight.

•Project planning for CSV notification system for CQA notification board for manufacturing.

PFIZER, Inc., McPherson, Kansas AUG 2018 – JAN 2020

Senior Validation Engineer – Permanent

Develop theory and content of validation documents and reports for, new equipment, laboratory instrumentation, software, manufacturing, and shipping processes. Creation, revision, review, and approval of Standard Operating Procedures, Work Instructions, and technical documents for process mapping and improvement. CSV project plans, protocols, and report authoring, review, and approval. Review and facilitate changes and on-going review and revalidation to ensure that validation documentation is compliant with ALCOA, DATA Integrity and Plant and Corporate validation requirements and policies, as well as with regulatory expectations.

•Work closely with validation change owners from Engineering, Manufacturing, logistics and IT to plan and draft validation documents and assure proper execution/documentation of test results. CSV remediation to adhere to current guidance and regulations and remediation activities for 21CFR Part 11 and GAMP 5 Data Integrity and ALCOA industry guidance.

•Ensure validation documentation is in compliance with Plant and Corporate policies and procedures. Ensured validation packages contain all relevant information, rationales, references, and data.

•Write and/or assist with the writing of Validation Master Plans. Write and assist with the writing of Standard Operating Procedures. Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.

•Assist with the remediation, review or revalidation of existing manufacturing process validation, cleaning validation, plant equipment/facilities/utilities/control systems/software, computer system validation (CSV).

•Assist with preparing documentation or presentations for regulatory inspections. Work with site and corporate audit support teams during internal and external audits / inspections. Interact directly with regulatory inspectors to present and defend validation program.

MANGAN, Inc., Pfizer McPherson Site MAR 2018 – JUN 2018

Senior Validation Specialist – Contract Consultant

Execution of autoclave qualification activities, data evaluation, and creation of final reports.

•Execution of autoclave validation protocols.

•Review of executed protocols for industry standard expectations for autoclave and control systems (CSV); corrections made to executed protocols.

•Evaluation and compilation of qualification data and completion of final reports.

FAGRON STERILE SERVICES / JCB LABORATORIES, Wichita Kansas FEB 2017 – DEC 2017

Validation Manager – Permanent

Manage and oversee contract personnel used by Fagron Sterile Services (FSS) and JCB Laboratories (JCB). Developing and implementing a defined validation program including Validation Master Plans (VMP) and Standard Operating Procedures (SOP).

•Manage Projects and Validation activities; creating timelines as needed to track project completion.

•Manage ProPharma or any other contract personnel used to perform Validation activities.

•Review and approve all Validation protocols, final reports, addendums SOPs and any other validation related documents.

•Worked with all functional areas of FSS/JCB in development of a formal Validation department.

Created roles and responsibilities, including job descriptions for the future state validation department.

Provide routine updates to management on progress of Validation activities.

HOSPIRA, Inc., a PFIZER Company, McPherson, Kansas MAY 2015 – FEB 2017

Senior Validation Engineer – Permanent

Develop theory and content of validation documents and reports for new equipment, laboratory instrumentation, software, Computer System Validation, and manufacturing processes. Creation, revision, review, and approval of Standard Operating Procedures, Work Instructions, and technical documents for process mapping and improvement. Review and facilitate changes and on-going review and revalidation to ensure that validation documentation is compliant with Plant and Corporate validation requirements and policies, as well as with regulatory expectations.

•Worked closely with validation change owners from Engineering, Manufacturing and IT to plan and draft validation documents and assure proper execution/documentation of test results. Responsible for reviewing, executing and approving validation documents.

•Ensured validation documentation is in compliance with Plant and Corporate policies and procedures. Ensured validation packages contain all relevant information, rationales, references, and data.

•Write and/or assist with the writing of Validation Master Plans. Write and assist with the writing of Standard Operating Procedures. Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.

•Assist with the remediation, review or revalidation of existing manufacturing process validation, cleaning validation, plant equipment/facilities/utilities/control systems/software, computer system validation (CSV).

•Assist with preparing documentation or presentations for regulatory inspections. Work with site and corporate audit support teams during internal and external audits / inspections. Interact directly with regulatory inspectors to present and defend validation program.

HOSPIRA, Inc., McPherson, Kansas 2010 – 2015

Customer Quality Engineer Supervisor – Permanent

Provided consistent and reliable Quality oversight for the One2One Contract Manufacturing Partners at the Hospira, McPherson facility to ensure reliable supply of safe, effective, and compliant medicines. Review, creation, and approval of quality and technical documentation in support of CMO activities such as Quality Agreements, SOPs, and Change Management.

•Quality support for the One2One partners at Hospira, McPherson to facilitate issue resolution, deviation support, regulatory items, validation protocol approval and questions and batch release. Primary quality contact with One2One partner working teams.

•Supervised one to two Customer Quality Engineers providing training, guidance and development.

•Review of deviation reports, providing comments, correction, and coordination of partner comments and questions. Final deviation report closure for partners for low and medium level deviations. Coordinate creation and completion of Corrective / Preventative action(s).

•Review of change control at the facility and communication of changes to One2One partners. Support of questions on change control for One2One. Change Request Board representative for One2One.

•Validation protocol and report review and approval for One2One partners. Including Equipment, Facility, and Utilities and CSV validation plans, protocols and reports.

HOSPIRA, Inc., McPherson, Kansas 2008 - 2010

Contract Manufacturing Analyst – Permanent

Acted as the direct liaison between the One2One partner and the Hospira, McPherson facility to ensure correct and timely manufacture and release of the partner’s medicine. Review, creation, and approval of operational and technical documentation in support of CMO activities such as Quality Agreements, SOPs, and Change Management.

•Program management of new and current partner projects including all new product lines, procedural and artwork revisions, and product transfers.

•Daily interaction with multiple levels of partner management to ensure on time delivery of product and project deadlines.

•Management of scheduling for partner manufacturing and quote creation for new activities.

•Creation and revision of partner documentation and databases for use in manufacturing.

•Change Request Board representative for One2One. Coordinated Change Request notification and One2One partner questions prior to creation of Customer Quality group.

HOSPIRA, Inc., McPherson, Kansas 2006 - 2008

Production Supervisor – Permanent

Managed and controlled manufacturing operations to ensure a high level of operational efficiency in support of company goals and objectives.

•Managed the production activities of 18 to 31 individuals on manufacturing filling and packaging operations. Mediated employee confrontations and conducted team meetings in order to optimize shift production.

•Updated and revised manufacturing procedures and batch records for clarification and/or procedural changes.

•Worked with the various departments of the McPherson facility to ensure products were manufactured following cGMP’s.

HOSPIRA, Inc., McPherson, Kansas 2004 - 2006

Chemist II – Permanent

Responsible for testing of in process and final medicine products to ensure efficacy and adherence to manufacturing specifications.

•Group Leader, Chemistry Quality Plant Validation Support; trained in CDA and potent compound activities. Maintenance and validation of instrumentation; coordinated creation of database to track chemical inventory.

•Performance, documentation, and reviewing of HPLC, TOC, GC, and Pierce Protein cleaning validations. Review of Validation protocols to be executed by Chemistry Quality; peer review of executed protocols. Completed investigations and exception reports for deviations that occurred during execution of validation testing.

TRAINING

•Six Sigma Green Belt – McPherson, KS – March 2007

•CAPA Investigation Trainer – McPherson, KS – August 2014

EDUCATION

•OREGON STATE UNIVERSITY, Corvallis, OR – Biology (BS); minor in Chemistry, 2002

•OREGON STATE UNIVERSITY, Corvallis, OR – Management Information Systems (BS), 2002

COMPUTER SKILLS

•Creation, testing, and validation of in-house software (Microsoft Access and Excell) following CSV GxP principals and industry guidance. Automation systems and control systems CSV remediation and validation utilizing in house created test scripts and approved vendor supplied protocols.

•Microsoft Suite of software: Windows 7/10/11, Windows Server 2000/2016, Office 2010-2016 (Word, Excel, Project, Visio, Access); Process mapping and program management (Gantt charts)

•SAP; TrackWise, JDEdwards (AS400), Control Systems, Apple OS X, LINUX, Windows Server 2010-2016, SQL, Database Creation/Maintenance

•Local Area Network/Infrastructure development, implementation, and maintenance for Kappa Sigma Fraternity at Oregon State University, 2001-2002

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