Marcus Muffley Email & Phone Number

Bend, Oregon, US

• Project manager for all aspects of the GMP manufacturing expansion including management of contractors, design firms, consultants, and internal stakeholders.
• Develop and align the project teams throughout each project to ensure all aspects of the project are on-time, on-budget, and of the highest quality standards possible.
• Maintains internal and external stakeholder agreement and buy-in to keep the project schedule on-track.
• Responsible for communicating project updates and deliverable status to all impacted personnel.
• Ensure all project documentation is completed and aligned to maintain GxP standards, including FDA 21CFR Part 11 data integrity requirements.

Waltham, MA, US

• Project manager and SME for implementing the GMP pharmaceutical manufacturing site’s first computerized maintenance management system (Maximo).
• Responsible for coordination/reconciliation of all GMP Manufacturing, Quality Control and R&D equipment; consisting of over 1350 qualifications, calibration, and maintenance events annually.
• Management of vendor quality approval, scheduling, and review of executed calibration certificates and reports.
• Review and approval of all GMP work orders for all GMP maintenance events.
• Responsible for generating all capital asset requests for the site and maintain strategic budget. 2021 consisted of 48 capital asset requests totaling over $11.8 million USD.
• Site representative for client audit inquiries regarding maintenance management and processes.

Scottsdale, Arizona, US

• Developed, implemented, and updated best practices to streamline operations, standardized processes, and enhanced customer service.
• Responsible for 25 supervisors’ overall performance and coaching.
• Ensured swift resolution to team issues while complying with company policies.
• Updated leadership team weekly on the company’s performance metrics and trending, and forecasting.
• Trained, inspired, and rewarded a team of customer service supervisors to further company goals and sustain high customer service benchmarks.

Washington, DC, US

• Managed and resolved operations issues in the facility including safety incidents, disagreements between employees, scheduling/planning and last-minute decision making.
• Ensured staff members adhere to established policies, procedures in cGMP environment.
• Managed 35 staff during highly regulated blood collection process to ensure safety, quality, purity, potency, of the product.
• Provided technical direction and supervision to the unionized operations workforce.
• Performed immediate corrective action to correct any variables preventing goal attainment.

Washington, DC, US

• Developed and executed system and process audits to ensure that operational departments are operating within compliance and prepared for external Federal audits (FDA).
• Team lead on performing root cause analysis investigations for deviations, monitored the implementation and effectiveness of corrective action plans.
• Researched company procedures, Code of Federal Regulation, and AABB standards to write and present non-conforming product cases to the Material Review Board for evaluation and final disposition of suspect product.
• Regional Quality Assurance liaison for hosting FDA auditors during annual inspection
• Reviewed Equipment Validations, Qualifications, Advertising and Promotions, Labeling material, Batch Release records, inspect returned blood products for redistribution, customer concern coordinator.

Washington, DC, US

• Assisted Quality management in implementing and enhancing new and existing quality systems.
• Assisted in design and implementation of a Regulatory Reporting QA Testing Plan covering Trade and Transaction Reporting, including designing, coding and deployment of QA tests.
• Developed and conducted system audits to ensure product and process quality is maintained in all operational departments.
• Collaborated with product specialists and others to effectively deliver solutions to customers.

Washington, DC, US

• Managed all precautionary and safety measures to control equipment operations and ensured periodic checks and corrections.
• Verified all validation plans met the all Federal quality standards and requirements.
• Reinforced and enhanced residual policies, controls and analytical approaches to support company’s equipment and risk management objectives.
• Assisted in strategic cost saving measures by increasing efficiency.
• Maintained databases, resource/reference materials, and a library of equipment document history and performance.

Project Management

Business Administration And Management, General

General Studies