Harry Obamije

Provide technical leadership and oversight to ensure high-quality production in a multi-product GMP facility, serving as the subject matter expert (SME) for on-the-floor activities. Partner with cross-functional teams and executive leadership to strategize and drive process improvements, ensuring alignment with site goals and compliance standards. Developed comprehensive site scorecards tracking key performance metrics, including filling adherence, batch release, deviation resolution, CAPA closures, training compliance, and safety records.

Selected Accomplishments:

• Streamlined low-inventory product release processes using Kaizen strategies, reducing lead times, and enhancing customer satisfaction.
• Oversaw line transfer initiatives to meet accelerated timelines for exhibit batch production, aligning with CAPEX goals to integrate new high-speed isolators for pharmaceutical drug manufacturing.
• Improved departmental productivity by prioritizing resources across manufacturing and support functions, achieving consistent alignment with schedule and performance metrics.
• Led risk mitigation, policy, and GMP training sessions, fostering a culture of safety, compliance, and operational excellence.
• Implement lean manufacturing and 5S methodologies to enhance workflow within the compounding unit, reducing waste and downtime while improving safety and process consistency.

Recruited and developed the Operations Excellence division, bringing extensive expertise in the pharmaceutical industry with a focus on operational efficiencies, process improvements, and strict GMP compliance. Led cross-functional teams to implement Lean and Six Sigma methodologies, driving optimization of production processes to consistently meet quality and productivity goals. Managed CAPEX projects, equipment qualifications, and technical documentation to support high-priority manufacturing initiatives. Focused on continuous improvement while cultivating a high-performance culture, ensuring alignment between operations and organizational objectives to achieve sustainable, long-term success.

Selected Accomplishments:

• Spearheaded continuous improvement projects across departments to enhance equipment efficiency.
• Increased commercial filling uptime by 13% through gap analysis and streamlined setup processes.
• Developed a triage risk matrix to accelerate the on-time release of finished goods amid process deviations.
• Implemented advanced visual inspection technologies, reducing product waste by 10% and improving product loss from FY19 to FY20.
• Oversaw machinability studies, identifying cost reduction opportunities while maintaining quality.
• Partnered with commercial planning to leverage KPIs, reducing days of inventory by 35%.
• Improved yield loss by 10% through a visual verification system for finished goods reconciliation.
• Coordinated the on-time release of commercial goods, working closely with Commercial Operations, Manufacturing, QA, and Packaging.
• Led leadership development training programs for direct reports.

Led and developed a high-performing investigation team to resolve process deviations, ensuring strict adherence to regulatory requirements, GMP, and relevant USP guidance, including USP Chapters (GMP), (Microbiological Control), and (Validation of Compendial Methods). Ensured full compliance with 21 CFR Part 11 for electronic records and signatures. Guided cross-functional teams through root cause analysis, implementation of corrective and preventive actions (CAPAs), and effective monitoring of results. Spearheaded the preparation of comprehensive documentation and detailed reports for regulatory audits, ensuring deviations were addressed in alignment with internal policies, industry best practices, and applicable standards, ultimately maintaining consistent product quality and safety.

Selected Accomplishments:

• Managed deviations for formulation, filling, inspection, packaging, validation, facilities, and engineering operations.
• Trained and mentored manufacturing leads and supervisors in deviation writing, reducing backlog by 40%.
• Led site-wide initiatives to strengthen aseptic controls, improving cleanroom bio-burden recovery, and reducing contamination risks.
• Applied Failure Modes and Effects Analysis (FMEA) to streamline CAPA implementation and ensure effective resolution.
• Managed Annual Product Review (APR) reports for Production, aligning them with USP guidelines to meet quality standards.
• Collaborated with plant management to ensure timely and accurate product shipments, achieving case fill rate KPI targets.

Executed process deviation investigations, ensuring GMP and regulatory compliance. Coordinated cross-functional teams for root cause analysis, CAPA implementation, and ongoing effectiveness monitoring. Prepared deviation reports and maintained accurate documentation, aligning with internal policies and industry best practices. Collaborated with quality assurance and manufacturing to efficiently resolve deviations and maintain product quality and safety.

Selected Accomplishments:

• Delivered timely process investigations to facilitate the release of commercial products, effectively addressing anomalies in production.
• Reduced process deviations by 38% by applying risk management tools to improve formulation, sterile filling, inspection, packaging, and engineering processes.
• Applied expertise in process engineering to support short-term renovation projects, optimizing manufacturing workflows and improving quality efficiency.
• Managed temporary investigation specialists, leading to a 100% reduction in investigation backlogs and contributing to the successful resolution of an FDA warning letter.
• Led internal and external audits, ensuring compliance with quality standards and driving corrective actions to completion.