M Blake Edwards
Malvern,PA
Summary
An industry-diverse quality, regulatory, and risk management leader with an inherent capacity for problem-solving, implementing process improvements, and fostering new company quality management system discipline and standards. Applies 20 years of diverse industry expertise cultivating quality culture and delivering operational efficiencies, quality compliance, and effective product launch and roll out. Holds both an MBA and MSc accompanied by quality accreditations ISO 9001:2015 Lead Auditor, Internal Auditor, ISO 19011:2018 Auditing Module, and Team Leader. Highly organized results-oriented Certified Operational Excellence Black Belt recognized for coaching style and pioneering the creation of enterprise quality management structures. Applies strong pharmaceutical knowledge safeguarding company GxP compliance applying solid judgment derived from experience in outcome. Additional qualifications include Certified Professional Supply Management, Accredited Purchasing Practitioner, Certified Purchasing Manager, Certified Professional Supplier Diversity, and Certified Supply Chain Professional.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Head of Quality
Gateway Services Inc.
03.2023 - 11.2023
- Remote role managing enterprise quality function directing development and implementation of all quality processes, procedures, and corrective actions across 150+ sites, boosting operational compliance for 2,000 employees; implemented 4 quality process improvement strategies reducing site operational costs by average of 8% within first 30 days in role.
- Conducted regular audits of production processes, identifying areas for improvement and implementing changes to enhance overall product quality.
- Championed culture of continuous improvement by fostering open communication channels between employees at all levels within organization enhancing employee engagement in quality initiatives by recognizing individual contributions and promoting culture of accountability.
- Collaborated with suppliers to establish stringent quality criteria for incoming materials, enhancing overall product consistency and reduced waste by optimizing manufacturing processes, increasing overall production efficiency while maintaining high-quality output.
Head of Quality
Adesis Inc.
01.2022 - 01.2023
- Founded a quality department for a newly established contract development and manufacturing organization (CDMO) and restructured 73 quality processes, introduced regulatory reporting, certified ISO 9001, streamlined 2 MRP programs, modernized 43 SOPs, and governed and simplified company QMS and served as company Controlled Substance (CS) responsible person and customer audit point person.
- Initiated cross-functional collaborations with engineering and manufacturing teams to identify root causes of defects and implement corrective actions and evaluated quality problems and performed assessments to identify and resolve issues.
- Managed resolution of customer complaints, leading investigations to determine cause and implementing corrective actions to prevent recurrence and coordinated recall efforts when necessary, collaborating with internal stakeholders as well as external partners to ensure effective communication and resolution strategies were employed.
- Led a team of quality assurance professionals, ensuring consistent adherence to company standards and regulatory requirements and streamlined quality control processes by integrating automated systems and reducing manual inspection tasks.
- Evaluated vendor performance through routine assessments, recommending adjustments or replacements as necessary to maintain optimal supply chain relationships.
- Calibrated instruments and scales in production area and quality lab and coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
- Developed and deployed production control plans and created work instructions and procedures and developed comprehensive training programs for new hires, resulting in increased efficiency and knowledge among staff members.
Senior Quality & Risk Management Director
GSK
11.2016 - 12.2021
- Created and instructed pharmaceutical R&D on global quality and risk strategy, development, implementation, and risk mitigation tactics
- Served as Quality Risk Management (QRM) business partner launching new risk identification models, simplified risk evaluation, and refined risk mitigation process
- Simplified written standards, aligned business support functions, shaped quality policy, and united training efforts to maximize compliance and sustain, control, and continuously improve QRM processes across R&D.
- Reduced operational costs with the introduction of automation tools and lean methodologies within the R&D department.
- Developed innovative research strategies by collaborating with cross-functional teams to identify and address critical business needs.
- Increased patent portfolio value by identifying novel technologies and guiding teams through intellectual property process.
- Streamlined communication channels between R&D teams and other departments, improving cross-functional collaboration for efficient problem resolution and routinely promoted culture of innovation, fostering environment that encouraged creative problem-solving and collaboration among team members.
- Championed a data-driven culture within the R&D department, resulting in more informed decision-making and better project outcomes.
Quality & Risk Management Director
GSK
04.2014 - 10.2016
- Spearheaded and curated the initiation, development, and implementation of a new digital risk management system; introduced risk severity modeling and pulled on ROI data to strengthen risk decision-making and mitigation efforts
- Introduced risk forecast functionality and AI monitoring using the newly formed R&D data platform and charting the R&D Platform Technology & Science collective.
- Minimized risk of non-compliance penalties by conducting regular internal audits and implementing corrective actions as needed.
- Led efforts to obtain necessary certifications for products, allowing for increased market access and revenue growth.
- Contributed to positive audit outcomes by maintaining comprehensive knowledge of current regulations and proactively updating relevant policies and procedures accordingly.
- Developed comprehensive employee training programs focusing on critical aspects of industry regulations, resulting in increased awareness among staff and a strengthened compliance culture.
- Championed the adoption of new regulatory strategies by staying abreast of industry trends, attending relevant conferences, and participating in networking events with key stakeholders.
- Coordinated multidisciplinary review teams to evaluate product safety concerns, resulting in more informed decision-making and risk mitigation efforts.
- Increased efficiency in reporting adverse events by streamlining data collection methods and improving interdepartmental collaboration.
- Ensured high-quality submissions for various product categories through meticulous attention to detail in preparing documents according to agency guidelines.
- Enhanced company compliance with FDA regulations through thorough review and editing of product labeling and promotional materials.
Global Category Procurement Director
GSK
06.2012 - 04.2014
- Identified opportunities for process improvement through data analysis, resulting in increased operational efficiency within the procurement department.
- Evaluated emerging technologies to enhance procurement operations such as e-sourcing platforms or automation tools.
- Achieved substantial cost savings with the implementation of a centralized procurement system for better spend visibility and control.
- Enhanced supplier relationships through regular communication, collaboration, and mutual goal-setting for long-term partnerships.
- Championed procurement best practices throughout the organization by providing training and support to stakeholders in areas such as contract management, supplier selection, or risk mitigation.
R&D Procurement Director
GSK
06.2008 - 06.2012
- Conducted regular audits of vendor compliance with contractual obligations, ensuring adherence to established terms and conditions.
- Evaluated potential suppliers based on financial stability, capacity, quality, and service capabilities before entering into agreements.
- Analyzed market trends to identify opportunities for cost reduction or operational improvements in procurement activities.
- Spearheaded successful contract negotiations with major suppliers, securing favorable pricing structures without compromising on quality or service levels.
- Established robust supplier performance metrics for continuous improvement and accountability.
- Delivered substantial bottom-line impact by identifying inefficiencies in existing procurement processes and implementing corrective measures.
- Led cross-functional teams in the development of new product sourcing strategies, maximizing profitability while minimizing risk exposure.
- Enhanced supply chain visibility with the implementation of advanced tracking systems and reporting tools.
Procurement Manager
GSK
08.2006 - 07.2008
- Ensured compliance with corporate policies and industry regulations by implementing robust procurement controls and monitoring systems.
- Developed strong relationships with key suppliers, resulting in improved communication, better pricing, and reliable delivery schedules.
- Spearheaded change management initiatives within the procurement department, leading to improved agility and responsiveness in meeting business needs.
- Led cross-functional teams in the development of procurement strategies for major projects, ensuring alignment with business objectives.
- Monitored inventory levels and avoided shortages with timely replenishment of stock.
- Collaborated with internal stakeholders to create timely and accurate purchase orders.
Buyer
GSK
06.2005 - 08.2006
- Participated in trade shows and conferences to stay informed of the latest industry developments and maintain a strong professional network.
- Continuously monitored industry trends to identify new supply sources that could potentially improve overall procurement efficiency.
- Achieved cost savings by identifying opportunities for consolidation and bulk purchasing across departments.
- Coordinated with logistics teams to resolve any shipping delays or discrepancies while minimizing impact on operations.
- Reviewed legal documents such as contracts and non-disclosure agreements to ensure compliance with company policies.
Future Leader Program (FLP)
GSK
06.2004 - 08.2005
- Supported senior researchers in managing projects, ensuring timely completion of tasks and milestones.
- Maintained a safe laboratory environment by adhering to strict safety protocols and guidelines.
- Prepared thorough documentation of research findings, facilitating knowledge transfer within the team.
- Actively participated in departmental meetings, providing valuable input towards project planning and execution.
- Generated high-quality data sets by meticulously executing experimental procedures according to standardized protocols.
Education
Master of Science - Health Policy, Organizational Dynamics & Economics
University of Pennsylvania
Philadelphia, PA2010
MBA - Public Health & Labor Union Relations
Alvernia College
Reading, United States2008
Bachelor of Science - Business Logistics Supply Chain Management
Pennsylvania State University
University Park, PA2004
Associate of Applied Science - Clinical Supply Chain Strategy Development Cohort
Villanova University
Villanova, PA2012
Skills
- Operational Excellence
- Product Inspection
- Quality Management Systems
- Documentation Control
- Change Control Management
- Quality Metrics Monitoring
- CAPA Management
- GMP, GCP & GLP Knowledge
- Continuous Improvement
- Operational Improvement
- Regulatory Compliance
- Compliance Monitoring
Certification
LEAN SIGMA GREEN BELT
- Implemented lean practices enhancing ordering and utilization practice of lab supplies consumables; reduced over ordering norms and waste resulting in improved lab efficiency and cost containment.
OPERATIONAL EXCELLENCE BLACK BELT
- Improved the quality and right-first-time performance metrics across the oral-dose manufacturing capability removing defect-causing elements and streamlining the changeability between manufacturing campaigns.
Quality Industry Certification
The International Organization for Standardization (ISO)
- ISO 9001:2015 LEAD AUDITOR
- ISO 9001:2015 INTERNAL AUDITOR
- ISO 19011:2018 TEAM LEADER
- ISO 19011:2018 AUDITING MODULE
Supply Chain Management Certification
Association for Supply Chain Management (APICS)
- CERTIFIED PROFESSIONAL SUPPLY MANAGEMENT (CPSM)
Institute for Supply Management (ISM)
- CERTIFIED PURCHASING MANAGER (C.P.M.)
- CERTIFIED PROFESSIONAL SUPPLIER DIVERSITY (CPSD)
- CERTIFIED SUPPLY CHAIN PROFESSIONAL (CSCP)
Languages
German
Professional Working
Timeline
Head of Quality
Gateway Services Inc.
03.2023 - 11.2023
Head of Quality
Adesis Inc.
01.2022 - 01.2023
Senior Quality & Risk Management Director
GSK
11.2016 - 12.2021
Quality & Risk Management Director
GSK
04.2014 - 10.2016
Global Category Procurement Director
GSK
06.2012 - 04.2014
R&D Procurement Director
GSK
06.2008 - 06.2012
Procurement Manager
GSK
08.2006 - 07.2008
Buyer
GSK
06.2005 - 08.2006
Future Leader Program (FLP)
GSK
06.2004 - 08.2005
Master of Science - Health Policy, Organizational Dynamics & Economics
University of Pennsylvania
MBA - Public Health & Labor Union Relations
Alvernia College
Bachelor of Science - Business Logistics Supply Chain Management
Pennsylvania State University
Associate of Applied Science - Clinical Supply Chain Strategy Development Cohort
Villanova University
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