Designated Representative / Facility Manager
Location: Horsham (PA), United States
Clinical Services International is a global leader of pharmaceutical products and services for clinical trials. We do Intelligent Sourcing of medicines, Generics, Diagnostics and Medical Devices throughout the world, supplying the clinical trials that develop tomorrow’s medicines.
We manage the entire supply chain and offer tailor-made solution for clinical trials. We have grown very significantly, and we are now looking to appoint a Designated Representative / Facility Manager in our warehouse/office in Horsham (PA), USA
Responsibilities
-
Take responsibility and act as the 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 directed by CSI’s strategic plan.
-
Ensure that internal controls are in place and that appropriate corrective and preventive measures are implemented collaborating with the Global Quality Assurance Manager (GQAM).
-
Provide support and act as directed by 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.
-
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.
-
Ensure 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 additional requirements imposed on certain products by State law are adhered to.
-
Follow the entire order lifecycle: serve as a regular point of contact with clients supervising procurement of goods, logistics and delivery to the client.
-
Pro-actively communicate the project status to all stakeholders and actively ensuring on-time project delivery.
-
Coordinate workflows with various service providers to fulfil complex projects in a timely manner with maximum client satisfaction.
-
Identify and proactively resolve order-related discrepancies from a quality and financial perspective.
-
Coordinate processes with logistics service providers: depots, carriers, customs agents and relabelling / repackaging providers
-
Using a combination of your own initiative and management direction, work towards the elimination of operational concerns taking a continuous improvement approach to minimise risk and improve processes.
-
Comply with all CSI Global Procedures, Policies and Local SOPs.
-
Efficiently report, investigate and resolve quality incidents and liaise with suppliers, clients, depots and carriers as required.
-
Completion of other responsibilities as delegated by the Director of Strategy and Business Development and/or the Global Quality Department
Job Description
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 having oversight and relationship responsibilities for certain American clients.
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.
Person Specification
-
At least 3 years experience within the pharmaceutical industry (Essential)
-
knowledgeable of the FDA and state requirements for Wholesale Dealers (Essential)
-
Degree in a scientific discipline (such as Biology, Pharmacy, Chemistry etc.) (Essential)
-
Able to attend the Horsham (PA) site 5-days a week (Essential)
-
Project Management / Account Management experience (Desired)
-
Logistics / Warehouse operations experience (Desired)
A critical component of this role requires you to be familiar with, aware of and responsible for the company’s legend (prescription) drugs and/or device business, including writing and ensuring adherence to policies and procedures, storage, security, temperature control, inventory counts, pick/pack and shipping operations, customer returns, and recalls.
In return we offer:
An amazing opportunity to contribute to a fast growing, pharmaceutical company. A 'can do' culture where you will be encouraged to get involved in a range of exciting initiatives and to introduce new ideas
The opportunity to learn new skills and ongoing personal development and career opportunities
What’s in for you?
Career Progression: You will be able to develop your career with a wide variety of opportunities and work with highly experience people in the industry. From continuing your professional development in clinical services, to engaging with Blue Chip Pharmaceutical clients all over the world. Develop scientific knowledge and expertise in clinical trials and drug development.
Package:
Competitive salary dependent on experience, annual leave, bonus structure, Pension Scheme, great working environment.
Location: Facility Based, Horsham (PA), USA.
.png){kind=logo}