mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

Job Description

• Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
• Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
• Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
• Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
• Maintain and track project budget(s).
• Reconcile the use of resources for the projects.
• Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
• Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
• Actively participate in directing the evolution and defining the role of the project.
• Ensure the project goals and objects are well understood by the various functional areas.
• Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
• Maintain the master project plan and schedule for assigned projects.
• Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
• Provide department management with project management support on an as needed basis as well as for special projects.
• May manage and direct the activities of project support staff.
• Conduct annual performance reviews, and provides career counseling and general guidance.
• Identify or lead focus area projects within the overall function of project management or related projects.
• Generate periodic updates and prepare formal presentations for required forums.
• Generate individual and more complex reports utilizing various resources.
• Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
• Ensure project work complies with practices, policies and standard operating procedures.
• Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
• Anticipate resource needs and communicate to management sponsors.
• Other functions that may be assigned.
   

Education

Doctorate degree OR Master's degree and 2 years of Project Management OR Bachelor's degree or and 4 years of Project Management experience Or Associate Degree and 10 years of experience or High school diploma / GED and 12 years of Project Management experience.

Preferred Qualifications

Life Sciences, Engineering, Material Management, Sciences, and related Hands-on experience with change control processes and systems. Focused on commercial product life cycle, manufacturing, product variations and/or new product introduction. Demonstrated ability on project management skills in balancing multiple responsibilities, priorities, tasks, and projects simultaneously. Experience on Quality roles Quality contact for change controls and or deviations Knowledge of SAP and Bill of material (BOM) management Experience with Regulatory field Strong organizational skills, diligent and accurate, analytical Fluent and highly proficient in English and Spanish communication skills (verbal and written) as peers will communicate in English across multiple countries Writing skills (extra) Experience on managing quality systems and/or managing deviations (non-conformances). (extra) Experience in scheduling and coordination around production schedules. (extra) Smartsheet knowledge, TrackWise (or equivalent quality or change control management) preferred, MS Office General Responsabilities In a GMP environment, design, conceive, progress and implement new or changes to existing customer facing (SKUs) change records (CFSCRs) within the Change Control Management quality system. In a GMP environment, design, conceive, progress and implement variants of product structures or intermediate SKUs to enable supply chain flow of product within the fill and finish site within the Change Control Management quality system. Interpret strategies and navigates through artwork, regulatory GMP systems and applicable technical assessments to ensure a compliant change is developed, prioritized, and progressed through all product stages in compliance with the respective guidelines and procedures. Makes sound decisions and projects adjustments based on data from Regional Operations Leads, planning tools, production planners, inventory scrap costs and resources capacity utilization. Supports manager in leading all aspects of project(s) within Supply Chain: planning, implementation, monitoring, follow-up, completion, and business partner meetings. Reports, communicates and presents metrics on variations implementations, launch completions and other activities related to the life cycle management of the Amgen products. May complete specific supply chain readiness projects and business cases.

Employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.