Quality Supervisor Analyst

Leroy Sykes

***********@*****.*** • 267-***-****

www.linkedin.com/in/leroy-sykes-5211453/ • Philadelphia, PA

IT Quality Assurance and Audit Director Profile

Pioneering senior-level IT professional with 20+ years of extensive experience driving business development and operational excellence through technical and transformational leadership for organizations within pharmaceutical industry.

Proven expertise in building sophisticated IT systems, planning and conducting multiple IT audits, and delivering successful system integrations to strengthen company’s IT infrastructure and data integrity. Demonstrable success leading large teams, collaborating cross-functionally, and navigating business relations to identify improvement areas, address critical risks, and offer solutions for boosting efficiencies in dynamic environments. Proficient in managing multiple vendor programs and completing complex IT projects in compliance with applicable laws, policies, guidelines, and business goals. Determined to adopt an innovative and analytical approach to improve staff engagement and maximize revenue generation.

Areas of Expertise

Business Innovation

Enterprise Management

Cross-Functional Team Collaboration

Process Mapping & Optimization

Governance Model Development

Regulatory Data Management

Employee Engagement & Inclusion

Governance, Risk & Compliance Management

Cellular Therapy Processes & Operations

IT Quality Assurance

Change Management

Finance Management

Audit Management

Performance Improvement

Technical Leadership

Accomplishments

Directed comprehensive administration of all site and enterprise systems, from strategy planning through to evaluation, implementation, end-user and administrator training, and go-live technical support.

Orchestrated all aspects of laboratory operations for cell therapy, GMP and non-GMP laboratories, and analytical and process development for all company sites in New Jersey.

Formulated risk-based QA strategy, SOPs, and training manuals for standardizing initial compliance audits, computer vendor audits, and internal system audits per company guidelines.

Career Experience

Celgene/Bristol Myers Squibb, NJ 2005 – 2023

Associate Director/Business Partnering/Cell Therapy Site Systems Lead

Lead and facilitate timely delivery of Quality Control (QC) and Clinical Manufacturing IT systems for cell therapy sites. Guide activities of ~10 consultants to manage shopfloor system and cell therapy production QC systems. Spearhead broad-ranging IT activities concerning infrastructure, architecture, project management, vendor and service management, systems validation, and cyber security through extensive knowledge of IT resources. Partner with clinical manufacturing and cell therapy QC stakeholders to outline future business roadmap based on organizational and solutions technical requirements. Utilize IT Stage-Gate process to oversee all demands from diverse site operations, including QC, warehouse and facilities management, and supply chain. Collaborate with vendors and business leaders to resolve emergent discrepancies on IT site. Coordinate multiple QC audits and inspections with site Quality Team. Develop and mentor competent application delivery/support team to facilitate future growth in key platforms globally.

Successfully managed $6M operating budget, regulated capital expenditure, and closed Service Management contract with Managed Service vendor to facilitate uninterrupted QC and manufacturing operations, IT cell therapy QC production, and shopfloor operations, leading to 10% reduction in operating costs.

Acquired and incorporated new tools/technology within cell therapy in collaboration with business user groups; delivered impactful solutions to optimize data security, analysis, sharing, and overall integrity.

Guided and enabled successful integration of QC system into LIMS system.

Governed audit actions, deviations, Periodic Monitoring reviews, and CAPAs to ensure seamless site IT quality management.

Liaised with key business stakeholders and IT experts to define and implement robust strategies for clinical supply chain operations and lab systems applications throughout organization.

Established risk-based period review process to optimize GMP stand-alone and enterprise lab systems, thereby aiding cell therapy and process and analytical development labs across New Jersey.

Championed strict adherence of clinical supply chain and lab system teams’ operations to all SOPs, SDLC, change control, and GMP standards concerning daily activities, suggested changes, project management, and all new development.

Organized and managed vendor and internal audit programs to ensure operations complied with federal laws and corporate expectations of computerized systems within GxP environment.

Monitored strict e-compliance of enterprise, GxP, and business system operations with ITQA standards.

Supervised computer validation process to ensure viability of GxP enterprise applications and critical business systems.

Additional Experience

Worldwide GMP Quality Supervisor, Merk & Company, West Point, PA

Validation and Quality Analyst, Spherion Tech Consulting, Newark, DE

Validation and Quality Analyst, Cap Gemini America LLC., Bala Cynwyd, PA

Education

Master of Science in Management Information Systems

Pennsylvania State University, University Park, PA

Bachelor of Science in Management Science and Information Systems

Pennsylvania State University, University Park, PA

Certifications

ITIL Foundation Certification – ITIL Training Experts – 2016

Six Sigma Green Belt (Commercially Certified) - The Council for Six Sigma Certification – 2014

ASQ Certified Quality Auditor - ASQ – 2012

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