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This position manages Commercial Accounts, Post Market Activities and New Product Launches as assigned and acts as key point of contact. Primary responsibilities include contract management, project oversight, change management, customer orders maintenance, and commercial quotations to support customer needs.
Job Responsibility:
Ensures that project delivery methodologies, project management processes/principles and project management tools are utilized to achieve project goals
Has ownership in site project management business processes and works with the customer relationship leader to improve these processes
Initiates and executes change controls using the quality management system
Responsible for managing the routine operational business relationship with customers
Maintains thorough knowledge and understanding of customer contractual requirements to ensure compliance and support effective operational execution
Oversees multiple, concurrent post market approval (PMA) / life cycle changes and projects impacting products in scope through the quality system change control process ensuring that changes are implemented compliantly and to avoid supply risks
Compiles commercial quotations to support customer and regulatory required tasks
Responsible for routine project management of product maintenance activity or post-commercial approval change projects, including key life cycle projects and business excellence initiatives as assigned
Leads order acceptance process, ensuring orders are confirmed within contractual requirements
Upholds customer contractual obligations and ensures site-wide compliance to minimize risk and maintain customer satisfaction
Delivers multiple concurrent PMA changes and projects on time and in compliance with quality system requirements, while proactively ensuring uninterrupted product supply
Requirements:
Requires a bachelor’s degree related to a science or engineering field, business management, project management, or supply chain management
4+ years’ experience working in regulated pharmaceutical manufacturing industry in a science or engineering field, supply chain or project management role preferred
The ideal candidate has obtained minimally a Certified Associate Project Manager (CAPM) certification, or equivalent, from a recognized institute focused on Project Management methodologies
Experience working in or managing a pharmaceutical laboratory, formulations, validation, research and development or production/packaging environment is beneficial in this role
Operating knowledge of cGMPs and regulatory requirements applicable to the domestic and global pharmaceutical manufacturing industry
Fundamental understanding of pharmaceutical manufacturing technologies and processes including for parenteral, oral solid dosage, soft chew, and non-sterile liquid dosage forms strongly preferred
The candidate must demonstrate a customer-oriented approach and an ability to manage teams and other project stakeholders through constraints to meet the agreed upon objectives and goals
Nice to have:
Experience working in or managing a pharmaceutical laboratory, formulations, validation, research and development or production/packaging environment is beneficial in this role
Fundamental understanding of pharmaceutical manufacturing technologies and processes including for parenteral, oral solid dosage, soft chew, and non-sterile liquid dosage forms strongly preferred