Summary
Overview
Work History
Education
Skills
References
Work Availability
Timeline
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Matthew Teli

Shrewsbury,USA

Summary

Accomplished Sr. Director at Novavax Inc., specializing in data integrity and validation. Expert in establishing quality governance and risk management strategies, leading to successful regulatory inspections. Proven ability to enhance operational efficiency and compliance through innovative policy development and team leadership. Skilled in CSV and fostering a culture of continuous improvement.

Overview

34
34
years of professional experience

Work History

Sr. Director Technical Quality

Novavax Inc. USA
10.2023 - Current
  • Oversight of Computer System Validation, Data Integrity, Quality Risk Management, and Process Validation functions.
  • Worked to modify/establish policies and procedures to meet CSV, DI, QRM, and PV, regulatory and industry expectations.
  • Oversight of multiple CMO’s
  • Review and approve PPQ plans, protocols, and summary reports.
  • I worked with MS&T to develop process control strategies and optimization through CPV.
  • Worked with MS&T and CMOs on tech transfer activities.
  • Reviewed and approved CMO deviations, Change controls, and CAPA’s
  • Audited CMOs for compliance.
  • Supported CMOs during regulatory inspection.
  • Established QRM policies and procedures.
  • Oversee Risk Management across all Novavax and CMO sites.
  • Managed the data integrity program.
  • Completed all DI gap assessments and closed all high-risk gaps.
  • Incorporated DI assessment into system/equipment introduction assessments.
  • Incorporated DI requirements into vendor quality agreements
  • Audited CMOs for DI gaps.
  • Performed internal audits.
  • Utilize AI tools such as Notebook to create knowledge libraries for Data Integrity, Quality Risk Management and CSV. The libraries are being utilized to ensure that Novavax policies and procedures are current and meet Regulatory and Industry Guidelines as applicable.

Sr. Director Digital Quality

National Resilience, USA
10.2021 - 10.2023
  • Oversee the Computer system validation and data Integrity programs at Resilience.
  • Oversee Digital Quality across six sites across the East Coast.
  • Established CSV and DI policies and procedures.
  • Worked with new sites acquired to ensure
  • That Resilience Corporate policies and procedures are adopted
  • Local procedures map to corporate policies
  • Perform Gap assessments and remediate any existing differences.
  • Manage implementation of corporate and site-level computerized systems.
  • MES (Apprentice)
  • SCADA system (Ignition)
  • ERP
  • Infrastructure
  • Infrastructure middleware
  • EAM
  • BMS
  • Corporate and site security infrastructure
  • QMS (Veeva)
  • Establish corporate Policies, Standards, and Procedures to meet regulatory and industry standards.
  • Oversee remediation of gaps at all sites based on Quality Improvement Plans and Data Integrity Gap Assessments.
  • Lead inspection readiness activities to prepare sites for audits. Collaborate with site technical quality leads and manufacturing management.
  • Oversee two Digital Quality Directors (at sites) and seven digital quality contractors.
  • Worked with the corporate digital group to establish quality by design and risk management initiatives.
  • Lead Data Integrity and Process Excellence team for Resilience.
  • Worked with IT and CSV teams to ensure that risk-based testing methodologies were applied across all phases of the computerized system lifecycle.

Director Validation

LSNE, Bedford, New Hampshire
Bedford, New Hampshire
07.2019 - 10.2021
  • Manage Process Validation, Equipment Utilities and Facilities, Computerized Systems Validation, and Data Integrity Groups for 6 LSNE facilities in North America.
  • Created validation policies, master plans, and procedures for all sites. Spearheaded multi-site training to ensure compliance with the new policies.
  • Built the validation department from the ground up, starting with 3 validation engineers to eventually 1 associate director, 2 senior managers, 2 program managers, and 9 additional validation engineers.
  • Created Validation program manager positions to establish standards for all LSNE facilities.
  • Created CSV policies and procedures for Manufacturing, Automation, IT, and QC equipment.
  • Worked with IT to establish and qualify Cloud-based storage systems (Intronis) and LSNE virtual server backup systems (Acronis).
  • Collaborate with QC on the implementation of MODA-EM and Empower.
  • Upgraded and Qualified all QC Equipment to meet Data Integrity requirements.
  • Directed the qualification of PI historian.
  • Created PPQ and CPV policies and procedures.
  • Led Data Integrity Remediation project for all sites. Determined compliance risks and created a portfolio of projects to address those gaps. Established internal audit programs to mitigate risks and enhance knowledge of site management. Rolled out training to all sites on ALCOA principles.
  • Managed startup of a new fill-finish facility, including aspects of Construction, Engineering, and Validation.
  • Applied risk-based approach to qualification of facility and equipment.
  • Ensured completed facility complied with European and US cGMP requirements.
  • Established a new validation department and managed all aspects of validation operations. Hired an additional 10 employees, including 4 Managers and 1 Associate Director.

Director, Corporate Engineering

Samsung Biologics, Incheon, South Korea
Incheon
07.2018 - 07.2019
  • Established and led the Data Governance team.
  • Established a Data Steward program, ensuring Data Integrity oversite at the department level.
  • Worked with SMEs on the implementation and qualification of Veeva and NETBACKUP.
  • Moved responsibility of qualification activities to manufacturing personnel and repurposed validation team to perform QAV role, strengthening QA technical oversite and reducing personnel required for a traditional process.
  • Created standardized templates and work instructions for all qualifications activities, reducing the normal review and approval cycle time.
  • Implement a Paperless validation system. Implement a Drawing management system.
  • Reorganized Maximo to enable forensic engineering activities.
  • Started initial plan for digitalization that involved the integration of Information Technology and Operational Technology.
  • Worked with IT to plan and execute an enterprise architecture to enable data integrity, storage and retrieval.
  • Created and established a knowledge management program for Samsung Biologics Corporate Engineering.
  • Manage the startup of a 2000L Single Use Facility. Provide engineering expertise on facility layout, equipment, materials, and personnel flow.
  • Created justification for manufacturing activities for closed systems in a Class D environment resulting in decreased facility usage and HVAC costs.
  • Created and Managed the Single Use System (SUS) program for Samsung.
  • Collaborated with Vendors to identify equipment that is fit for use.
  • Developed verification plans for a single-use facility based on risk.
  • Established SUS User Requirements, including Vendor Technical Diligence Audit procedures.
  • Executed Technical Diligence audits on Single Use vendors
  • Collaborated with Vendors on Particle Reduction, Leak Testing, Extractables, and Container Integrity
  • Established a Single Use end-user training program.
  • Lead Samsung SUS forum.
  • Created and established centers of excellence in various disciplines in Corporate Engineering to enable continuous improvement initiatives.
  • Improved validation life cycle procedures and policies in accordance with current regulatory requirements.

Senior Manager, Validation

Samsung Biologics, Incheon, South Korea
Incheon
07.2015 - 07.2018
  • Led Data Integrity Remediation Task Force responsible for ensuring compliance with regulatory requirements.
  • Established Samsung Data Integrity standards based on MHRA, FDA, PICS, PDA, WHO and ISPE guidelines.
  • Created User Requirements, Electronic Records Assessments, Equipment Impact Assessments and Quality Risk Assessment procedures to meet Data Integrity standards.
  • Created Data Integrity GAP assessment questionnaire for existing equipment based on risk to SISQP.
  • Performed Data Integrity Gap Assessments, Risk Assessments and Remediation Plans for all existing Manufacturing and QC equipment for two plants.
  • Developed a risk management strategy to manage Data Integrity control across all departments.
  • Led startup qualification of two manufacturing facilities with production capacities of 150,000L and 180,000L.
  • Directed validation tasks to bring new 180,000L facility from mechanical complete to GMP ready in 10 months.
  • Managed the day-to-day validation operations for a 30,000L facility. Organization included 70 employees.
  • Integrated risk-based testing into validation test templates which systematically simplified validation workload for all projects.
  • Reduced verification workload by 60% by establishing risk-based Cleaning and Sterilization approaches to minimize non-value-added activities.
  • Present validation materials during client audits and regulatory inspections.
  • Developed and managed Cleaning Validation Plans for multiple clients.
  • Conducted validation and GMP training.
  • Created and managed validation and quality metrics.
  • Developed Qualification plans including installation verification, cleaning, and sterilization qualification.
  • Approved hundreds of Protocols, Summary Reports, Exceptions and Change Management documents.
  • Created and approved operational and maintenance standard operating procedures (SOPs).
  • Oversaw validation activities of product tech transfer from multiple clients.
  • Worked with product development and clients to develop PPQ testing strategies for upstream DS.

Manager, Operations Validation

Genzyme, Allston, MA
Allston, MA
06.2012 - 06.2015
  • Manage the Operations Validation team consisting of eight FTE’s and multiple contractors.
  • Successfully managed consent decree numbered steps 11.02 (Facilities Equipment Utilities Qualification) and 11.10 (Sterilization) through final verification.
  • Collaborated with third party verifier, Quantic, to ensure that qualification methods and policies were compliant with regulatory standards.
  • Identify critical projects and influenced site leadership team to allocate resources for those projects.
  • Validation representative on governance body focused on continuous improvement, resource management and reduction of deviations.
  • Supported various regulatory inspections, including FDA, MHRA, and TGA.

Manager, Validation

Shire Human Genetic Therapies, Lexington, MA
Lexington, MA
02.2010 - 05.2012
  • Managed validation team of four FTEs and up to 25 contractors responsible for validation of Facilities, Equipment, and Utility at four Shire HGT sites. Primary validation point of contact for day-to-day operations.
  • Responsible for performance management, development, mentoring, and coaching of staff.
  • Oversaw validation activities of two start-up multi-product drug substance manufacturing sites.
  • Generate, review, and execute qualification/validation documents, including user requirements, functional specifications, control specifications, design reviews, and commissioning test plans.
  • Utilized a risk-based approach based on ASTM 2500 and ISPE guidelines.

Sr. Validation Engineer II

Shire Human Genetic Therapies, Lexington, MA
Lexington, MA
03.2008 - 02.2010
  • Managed relocation and qualification of equipment and systems for new QC laboratory, process development laboratory, and cell banking operations.
  • Managed the commissioning and qualification of a new packaging and labeling facility.
  • Supported technology transfer of multiple clinical and commercial products into a new fully disposable manufacturing facility.
  • Supported various regulatory inspections, including FDA, MHRA, MPA, Health Canada, GCA, ANVISA, etc…

Consultant, Validation

SVT Technologies LLC, Waltham, MA (at Wyeth BioPharma)
Waltham, MA
01.2003 - 01.2008
  • Responsible for approval of validation documents and management of validation projects.
  • Developed and maintained the validation program for a commercial manufacturing facility
  • Supported new product development and implementation by creating validation project plans, supporting engineering design, and executing commissioning activities.
  • Established a standard IQ/OQ template for company-wide use, reducing review time.
  • Supported internal and external investigations (FDA, EMEA, and SSA regulatory inspections).
  • Created changeover procedures for host cell changes: CHO to E.coli, CHO to CHO, E.coli to CHO.
  • Provided validation expertise in developing FAT and SAT procedures for new equipment.
  • Served as Validation member on Change Control Committee
  • Responsible for sourcing and review of contract support personnel and proposals.
  • Supported the CIP cycle development and Spray Ball Coverage Test development program for all vessels.

Senior Validation Engineer II

KMI PAREXEL, Waltham, MA (at Wyeth BioPharma)
Waltham, MA
01.2000 - 01.2003
  • Performed validation of computer systems, manufacturing facilities, and process equipment.
  • Created URS, FRS, and qualification test protocols. Review turnover packages for accuracy and completeness.
  • Performed GAP analysis of IQ, OQ, and PQs related to pharmaceutical bioprocess and critical utilities.
  • Performed CIP studies on Bioreactors, Buffer Vessels, Ultra Filtration Skids, Media Vessels, Product Transfer Lines, Harvest Vessels, and Filter Carts. Performed spray ball coverage testing.
  • Write and execute IQ/OQ/ PQ for Chromatography, Virus Retention, UFDF, and Core Integrity Skids.

Senior Automated Equipment Tech / Group Leader, Drug Product Operations

Astra Zeneca, Westborough, Massachusetts
Westborough, Massachusetts
01.1992 - 01.2000
  • Responsible for commercial operations and continuous improvement of drug product processes.
  • Performed maintenance of equipment: Cartridge Filler, Large Vial Filler, Combination Filler, and Ampule Filler.
  • Scheduled personnel for daily filling operations. Routinely trained operators.
  • Ensured proper maintenance of Class 100 and Class 10,000 areas. Routinely reviewed cleaning logs.
  • Ensured employees adhered to safety procedures. Documented and reported injuries.
  • Installed SPC system to monitor the volume of the filled product during operations.
  • Collaborate with Engineering and Validation to modify equipment and validate equipment changes.

Education

Bachelors - Mechanical Engineering

Andhra University
India

Skills

  • Quality leadership and governance
  • Data integrity and validation
  • Digital quality assurance
  • Risk management strategies
  • Regulatory compliance and inspections
  • Policy establishment and enforcement
  • Facility design and utilities management
  • Single-use systems expertise
  • Cleaning and equipment validation
  • CSV and GAMP 5 compliance
  • SDLC and data lifecycle management
  • Delta V, DCS, AB PLC, BMS, CMS expertise
  • HMI/SCADA and DMS proficiency
  • EAM (Maximo/BM) and PI historian knowledge
  • MES and ERP systems management
  • People management and development
  • Training and metrics oversight
  • GMP systems including LIMS and TrackWise
  • SAP, Oracle, Veeva, Veeam, Ignition proficiency
  • D365 and Orion familiarity
  • Process validation methodologies including PFMEA and PPQ
  • Continued process validation strategies for biologics manufacturing

References

References available upon request.

Work Availability

monday
tuesday
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thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Sr. Director Technical Quality

Novavax Inc. USA
10.2023 - Current

Sr. Director Digital Quality

National Resilience, USA
10.2021 - 10.2023

Director Validation

LSNE, Bedford, New Hampshire
07.2019 - 10.2021

Director, Corporate Engineering

Samsung Biologics, Incheon, South Korea
07.2018 - 07.2019

Senior Manager, Validation

Samsung Biologics, Incheon, South Korea
07.2015 - 07.2018

Manager, Operations Validation

Genzyme, Allston, MA
06.2012 - 06.2015

Manager, Validation

Shire Human Genetic Therapies, Lexington, MA
02.2010 - 05.2012

Sr. Validation Engineer II

Shire Human Genetic Therapies, Lexington, MA
03.2008 - 02.2010

Consultant, Validation

SVT Technologies LLC, Waltham, MA (at Wyeth BioPharma)
01.2003 - 01.2008

Senior Validation Engineer II

KMI PAREXEL, Waltham, MA (at Wyeth BioPharma)
01.2000 - 01.2003

Senior Automated Equipment Tech / Group Leader, Drug Product Operations

Astra Zeneca, Westborough, Massachusetts
01.1992 - 01.2000

Bachelors - Mechanical Engineering

Andhra University

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