Director Operational Risk Jobs in Puerto Rico (NOW HIRING)

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

• Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Amgen procedures.
• Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport.
• Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations.
• Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements.
• Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product.
• Identify and oversee implementation of new and improved business and compliance systems and tools.
• Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
• Responsible for business continuity programs for assigned areas.
• Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Amgen Supply Chain.
• Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts.
• Organize and communicate on a regular basis the total demand and supply requirements to senior management.
• Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan.
• Manage the process of gathering, evaluating and feedback of global demand requirements.
• Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans.
• Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
• Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.

• Ph.D ORMS + 2 years of directly related experience OR BS +4 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

• Educational background in Life Science and/or Engineering
• Written and Verbal communication in English and Spanish
• In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why’s)
• Supply Chain experience (receiving, suppliers, warehouse, shipping)
• Strong Technical Writing Skills
• Skilled in performance of GMP operations
• Compliance/Regulatory knowledge and interaction experience
• Experience leading cross-functional teams for RCA and problem solving
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, supply chain, and quality.
• Strong presentation skills.
• Project management skills.

• Complete Root Cause Analysis
• Apply Process Expertise – capable of understanding process and controls require to assess for potential causal factors
• Assess process performance by observation of floor operations and review of performance data.
• Support trouble shooting to identify Causal Factors and potential corrections
• Evaluate operational procedures
• Evaluate training requirements for technical aspects of the process
• Identify training opportunities
• Use and perform Risk Assessments as required to identify and understand risks and failure modes
• Define CAPAs
• Evaluate process improvement opportunities
• Negotiate Actions with Partners
• Deliver timely robust plan to address Root Cause
• Perform Impact to Process /Equipment /System Assessment
• Team with Product Development to understand potential impact to product quality attributes
• Assess Equipment/Systems information for potential impact to product quality attributes
• Assess for Data Integrity
• Assess for Process Validation Impact
• Author Investigation Report
• Use Technical Writing techniques proficiently
• Perform Data Verification
• Ensure timely report approval
• Support Peer Review
• Follow current standard procedures/templates
• Serve as SME to define deviation designation when called upon
• Facilitate Process and Equipment Risk Assessments and make recommendations to mitigate risks
• Participate in regulatory inspections
• Participate in the assessment or implementation of special projects or initiatives.
• Make strategic planning to support product supply and business performance metrics.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.