Carlos Bonilla
Project Manager & Quality
Operations Leader
11255 Shady Lake Run, Fort Myers, USA,--Professional summary
Project Manager & Quality Operations Leader with over two decades of comprehensive
experience in driving strategic execution and enhancing operational efficiency. Expert in
aligning enterprise transformation strategies with stakeholder needs, delivering projects on
time and within budget while ensuring regulatory compliance. Passionate about fostering
collaborative relationships and pioneering innovative solutions to propel organizational growth
and excellence.
Employment history
Mar 2018 - Mar 2024
Capital Program Manager & Project Manager, GlaxoSmithKline / HALEON
East Durham, NY
Fostered strong stakeholder relationships, aligning enterprise transformation strategies
with site requirements for successful project adoption.
Delivered capital projects on time and within budget, meeting value and quality benchmarks
while managing cross-functional resources efficiently.
Spearheaded PAS-X MES implementation through system configuration, testing, and
validation including hands-on GMBR design, creation, testing, workflow optimization and
system qualification, enhancing production efficiency, regulatory compliance and
production release rates.
Commissioned new packaging line, optimizing efficiency through automation and training.
Pioneered implementation of CoLOS Enterprise MES solution, revolutionising operational
technology framework and strengthening production monitoring capabilities.
Orchestrated network and automation infrastructure enabling OEE data collection from
existing packaging lines.
Assisted Engineering with comprehensive deviation investigations and root cause analysis
partnering with subject matter experts, establishing robust corrective actions and
preventive measures.
Supported Engineering and Finance with developing and submitting new projects
investment proposals for senior leadership approval through ePIP system.
Jul 2017 - Jan 2018
Remediation Engineer & Team Lead, Pfizer
McPherson, KS
Led technical writing team for critical remediation project, streamlining documentation
processes and ensuring regulatory compliance across multiple departments.
Spearheaded comprehensive review of open CAPAs, identifying gaps and implementing
solutions that measurably improved project efficiency.
Fostered cross-functional partnerships to align technical content with business objectives.
Jan 2017 - Jun 2017
Batch Assessment Consultant, Kedrion Biopharma
Melville, NY
Conducted batch records review assessments, analyzing data integrity issues and
implementing corrective actions to achieve regulatory compliance.
Streamlined BR review processes, enhancing overall efficiency in batch record management.
Developed remediation project KPI, metrics and progress tracker, facilitating project
management.
Apr 2015 - Dec 2016
Quality Systems Project Manager, GlaxoSmithKline
East Durham, NY
Cultivated stakeholder relationships through strategic partnerships, aligning diverse
objectives and driving project success through consensus-building.
Spearheaded TrackWise QMS implementation, optimising project delivery and resource
allocation. Drove data-driven decision-making across multiple departments.
Championed WMS-SAP integration, significantly improving order accuracy and inventory
management, resulting in streamlined operations.
Pioneered FreeWeigh deployment on packaging lines, revolutionising data collection
processes. Engineered creative solutions for complex operational challenges.
Orchestrated global data policy compliance through strategic network drive restructuring.
Delivered measurable improvements in data management and accessibility.
Sep 2013 - Apr 2015
Document Control SME Consultant, DePuy Synthes (J&J)
Palm Beach Gardens, FL
Conducted comprehensive gap analysis, strategically implementing Document Approval
Matrix which resulted in substantial error reduction and process optimization.
Collaborated with cross-functional teams to develop change control processes, aligning
with global quality plans.
Implemented strategic solutions for process optimization.
Jan 2013 - Jul 2013
Batch Record Review SME & Team Lead, Patheon
Mexico City, Mexico
Led team of 5 consultants reviewing batch records for product releases.
Collaborated on remediation strategies, resolving batch issues for compliant product
release.
Streamlined batch record review process, implementing data-driven KPIs to enhance
product release.
Transferred knowledge to QA and Production leads, coaching for compliance on the
production floor.
Sep 2011 - Jan 2013
Manager, Quality Assurance, PL Developments, Inc.
Miami, FL
Guided quality and manufacturing teams through FDA audits, ensuring regulatory
compliance and fostering a continuous improvement culture.
Assisted Operations with comprehensive deviation investigations and root cause analysis
partnering with subject matter experts, establishing robust corrective actions and
preventive measures.
Directed Oracle Agile PLM MES quality module design and implementation, enhancing
system integration and efficiency.
Revamped supplement registration process, significantly reducing approval timelines and
product market readiness.
Optimised SOPs for change control, enhancing compliance measures and elevating
document management practices.
Orchestrated department budget and implemented materials disposition protocols,
minimising waste and improving inventory accuracy.
2001 - 2011
Associate Director, Quality Services, Watson Laboratories, Inc.
Davie, FL
Unified cross-functional teams in document control and change management, driving
operational excellence and customer satisfaction.
Approved new product launch protocols, ensuring regulatory compliance and on-time
project delivery.
Led manufacturing operations across Blending, Compression, and Encapsulation units,
resulting in output increase of 15% through team empowerment.
Spearheaded quality management transformation through TrackWise QMS deployment,
optimizing deviation handling and CAPA processes across operations.
Conducted comprehensive deviation investigations and performed root cause analysis
partnering with subject matter experts, establishing robust corrective actions and
preventive measures.
Supported JDE MES implementation across Manufacturing, Packaging and Warehouse
operations leading to enhanced inventory control.
Streamlined quality assurance processes, achieving measurable improvements in
compliance and efficiency.
Mentored and challenged team members, fostering a culture of continuous improvement in
quality assurance processes.
Established comprehensive global quality protocols, ensuring adherence to industry
standards and regulations.
Skills
Team Leadership & Crossfunctional Collaboration
Program & Project
Management
Change Management &
Transformation Strategy
Budgeting, Forecasting &
Accrual Accounting
Site Remediation & Deviation
Investigations
Technical Writing & SOP
Development
Business Acumen &
Negotiation Strategies
Stakeholder Management &
Collaboration
Problem Solving & Decision
Making
Raw Materials, Intermediate
and Finished Products
Review & Disposition
Quality Assurance &
Regulatory Compliance (21
CFR part 11, 210, 211, 820, ISO
13485:2016, and ICH
Guidance)
Microsoft 365 Office Suite
(Project, Excel, Word,
PowerPoint, Teams),
SharePoint, SmartSheet,
Windows 10 & 11, Mac OS,
Citrix, SQL, Windows Server-, ServiceNow
Experienced
Experienced
Experienced
Experienced
Experienced
Experienced
Experienced
Experienced
Skillful
Experienced
Experienced
Experienced
PAS-X MES, Veeva QMS,
TrackWise, HP ALM,
Documentum, Qumas,
MasterControl, Document
Locator, Oracle Agile PLM,
JDE, SAP
Experienced
Education
High School Diploma
Dr. Alfredo M. Aguayo, Ponce, PR
BS, Business Administration
Broward College, Davie, FL
67 credits earned towards BS. Expected completion by 2027.
Courses
Oct 2023 - Dec 2023
Project Management Framework 10-hour course at Haleon
Jul 2022
PAS-X MBR Designer Training at Werum / Körber Pharma
Mar 2020 - May 2020
PMP Certification Boot Camp at Project Management Institute
Oct 2020
PAS-X Basic, Professional and Administrator Training at Werum / Körber Pharma
Nov 2018 - Dec 2018
OSHA 10-hour General Industry Safety and Health at OSHA
Oct 2016
Project Scoring & Portfolio Selection Process at Project Management Institute
Languages
English
Highly proficient
Spanish
Highly proficient
