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Designated Representative / Project Manager

Location: Horsham (PA), United States

Reporting to the Director of Strategy and Business Development, you will be our Designated Representative, directly responsible for our operations in the US, as well as a Project Manager with oversight and relationship responsibilities for certain American clients.

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As per State requirements for a Designated Representative, this position requires the successful applicant to be present on site for 5 days a week in our facility in Horsham (PA). There is no scope for hybrid or fully remote candidates.

Project Manager Responsibilities

  • Follow the entire order lifecycle: serve as a regular point of contact with clients, procurement of goods, logistics and delivery to the client

  • Drive projects towards success by supervising: communication, procurement, logistics, business development, operations, quality and administration

  • Pro-actively communicate the project status to all stakeholders, liaising with stakeholders to ensure on-time project delivery

  • Coordinate workflows with various service providers

  • Identify and proactively resolve order-related discrepancies from a quality and financial perspective

  • Coordinate processes with logistics service providers: depots, carriers, customs agents and relabeling/repackaging providers

  • Proactively collaborate with CSI colleagues worldwide to generate business opportunities and expand CSI’s reach

  • Support CSI’s growth by continuously seeking ways to improve quality, range of services and geographic coverage

  • Own and develop client and/or supplier accounts, as applicable

  • Using a combination of your own initiative and management direction, work towards the elimination of operational concerns

  • Comply with all CSI Standard Operating Procedures (SOPs) and Policies

  • Efficiently report quality incidents and liaise with suppliers, clients, depots and carriers as required

  • Other responsibilities as delegated by the Director of Strategy and Business Development

Designated Representative Responsibilities:

  • Take responsibility and act as point of contact for Federal and State regulatory compliance, and communication from the Federal and State agencies

  • Ensure operations adhere to Federal and State regulations as well as CSI’s Standard Operating Procedures (SOPs) and Policies

  • Maintain awareness and understanding of all applicable Federal and State regulations and provide updates to the global organisation for awareness and compliance

  • Drive the effort to obtain licenses in multiple states across the continental United States (US), as required by CSI’s strategic plan

  • Ensure that internal controls are in place and that appropriate corrective and preventive measures are implemented, assisting the Global Quality Assurance Manager (GQAM)

  • Provide support to the GQAM to ensure the efficient and effective operation of the Quality Management Systems (QMS)

  • Lead and/or participate in regulatory and client audits

  • Provide technical and quality system support to the wider business

  • Ensure that operations do not compromise the quality of medicines

  • Ensure that adequate records are maintained as per Code of Federal Regulations (CFR) requirements

  • Coordinate and promptly perform any recall operations for medicinal products

  • Ensure that relevant customer complaints are dealt with efficiently and effectively

  • Ensure the final disposition of returned, rejected, recalled or falsified products are handled diligently and in compliance with current regulatory requirements

  • Ensure that any additional requirements imposed on certain products by State law are adhered to

  • Be the contact for recalls in the US, supervise recalls and confirm the completion of all activities associated with the recall as defined in CSI procedures and Federal requirements

  • Other responsibilities as delegated by the Director of Strategy and Business Development and/or the Global Quality Department

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