Summary
Overview
Work History
Education
Skills
Accomplishments
Golf
Timeline
Generic

Harold Laws

Silver Spring,MD

Summary

A Dynamic Quality Manager offering over 13 years of extensive experience in the biopharmaceutical industry, specializing in the implementation and enhancement of quality systems and process improvement. My expertise lies in effectively leading cross-functional teams to remediate processes, manage projects, and apply effective strategies that boost productivity. With a profound understanding of manufacturing, operational quality, and regulatory compliance, I excel in identifying compliance gaps and devising innovative solutions. My diverse background enables me to approach challenges with a unique perspective, ensuring high-quality outcomes and adherence to industry standards. I am passionate about driving excellence and efficiency in quality management, aiming to bring transformative changes to your organization

Overview

10
10
years of professional experience

Work History

Quality Systems Manager (Lead)

GSK
11.2020 - Current
  • Spearhead the design and implementation of robust quality systems that governed regulatory compliance. Remediated the quality systems management improving site compliance
  • Served as lead quality approver for QMS documents and regulatory assessments helping to identify and close gaps and ensure regulatory compliance. Reviewed and Approved over 109 global quality documents.
  • Lead Project Manager for CI (Continuous Improvement) module migration to VQMS from M-ERP system.
  • Served as audit host for quality department. Extensive experience interfacing with regulatory auditors and driving site inspection readiness. Participated in audits as a subject matter expert for quality processes.
  • Managed third party quality audits with our company vendors to ensure product quality and efficacy.
  • Global team liaison for quality and regulatory compliance. fostering international relationships.
  • Managed team training compliance
  • Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards. Provide data and drive quality metrics for quality process systems.
  • Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines Per our QRM (Quality Risk Model which evaluates the health of quality processes at site.
  • Maintained quality system documentation and updated specific documents to reflect new audit regulatory and compendia requirements.
  • Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Managed the main initiative to establish quality culture at the site in the form of (quality starts with me) content.

Operational Quality Lead

GSK
08.2017 - 11.2020
  • Generate, support, coach, and approve investigations, laboratory investigations, corrective and preventative actions.
  • Understanding in lean and sig sigma problem solving techniques.
  • Ensured Investigations managed were thorough, well written, and have appropriate quality impact assessment attached. Ensured links between potential related events, root cause analysis is appropriately conducted and cohesive. Ensured CAPAs were established on the criteria of the true root cause.
  • Review and approved closure of Corrective/Preventive (CAPAs) and Effectiveness checks.
  • Review and Approve risk assessments for technical and non technical processes.
  • Provide information to support the Periodic Review process
  • Provide Support for batch release and batch record review for completion and accuracy.
  • Oversight of facilities, equipment, and personnel to ensure real time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements
  • Generation, review and approval of quality system records and documentation, including change control, technical reports, and master batch records
  • Support/Perform Self Inspections, Internal audits, and Inspection Readiness efforts
  • Represent QA on product/project teams, change control boards, deviations and other related process meetings.

Site GPS Practitioner

GSK
04.2017 - 03.2019
  • Supported day-to-day deployment of the GPS and performance improvement objectives at site.
  • Worked to deliver and drive metrics according to the GPS implementation approach agreed upon from site leadership
  • Used Six Sigma principles and strategies embedded within the GPS to work with site leaders to increase productivity output. Strategies approaches and help with execution of those team objectives.
  • Supported continuous improvement and capability development of self and others.
  • Tracked progress of the team deployment roadmap and analyzed data metrics to measure improvement.
  • Coached Site team leaders and operators to develop sustain continuous improvement mindsets and behaviors while also serving as a role model.
  • Provide expert advice on the GPS basics to the Site based on a in depth understanding of GPS
  • Lead GPS activities beyond the capability of the Site Teams


Lead Biopharmaceutical Associate III

GSK
09.2013 - 08.2017
  • Prepared, cleaned, sterilized, batched, pasteurized and filtrated delivery of media and solutions for cell culture and purification operations.
  • Performed the set-up, operation, cleaning and break-down of process equipment.
  • Performed sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics. Operate Filter integrity devices to confirm the integrity of filters pre and post use.
  • Follow appropriate standard operating procedures (SOPs), protocols and batch records to safely perform process operations and document compliantly with good documentation and data integrity practices.
  • Knowledge and experience with process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments
  • Conducted training of personnel involved in manufacturing process.

Education

Bachelor of Arts -

Washington Adventsist University
Takoma Park, MD
06.2024

Skills

  • Internal Control Systems
  • Risk Management Processes
  • Root Cause Analysis
  • Customer Service Standards
  • Continuous Improvement Process
  • CGMP Regulations
  • Documentation Control
  • Supplier Audits
  • Compliance Risk Management
  • Operational Processes
  • Quality Management System Compliance

Accomplishments

    2017 Initiated a change is the materials management process of how certain materials were decremented helping to eliminate waste of materials and ultimately saving the company over 100K in revenue for the year.


    2019 Successfully took over the QMS position at the site while site was in remediation and revamped the previous deficient adherence metrics for regulatory assessments and site compliance. Site Adherence changed from 43% to 95% under my leadership.


    2021 Managed the development of a training protocol to evaluate training gaps and the impact on product quality for the site. Areas looked at included, Training compliance history and trends. The potential of the operation to impact product quality and the complexity of the procedures and training structure. 3 campaigns of records going back 3 years were evaluated.

Golf

I enjoy playing gold.  Its a game I've grown to love.  I love the challenge it presents and spend most of free time trying to master it.  

Timeline

Quality Systems Manager (Lead)

GSK
11.2020 - Current

Operational Quality Lead

GSK
08.2017 - 11.2020

Site GPS Practitioner

GSK
04.2017 - 03.2019

Lead Biopharmaceutical Associate III

GSK
09.2013 - 08.2017

Bachelor of Arts -

Washington Adventsist University

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