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DSCSA Compliance Manager

Silver Spring Township, PA 17050

Posted: 09/22/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 583278 Is job remote?: No Country: United States

Job Description


Reporting directly to the Head of US Quality, the DSCSA Compliance Manager provides operational leadership and support for Sandozs DSCSA operations, as well as interaction and integration to the upstream and downstream supply chain stakeholders.

The role will be the primary point of contact for the various operational teams for all questions, issues and needs as it relates to DSCSA compliance. Working collaboratively with the SPT team, the role will provide input and recommendations for the development of solutions for the operational team, as well as stakeholders needs. This position will interface with and need to leverage the best of the existing and new solutions, as they are available and in use. The candidate will have the following competencies:
  • Significant experience/familiarity with relevant regulatory requirements, including federal and state regulations, Drug Supply Chain Security Act requirements, verification of trading partners, product recall execution, etc.
  • Ability to provide subject matter expertise in pharmaceutical distribution, product serialization, track and trace systems ( EDI/ASN 824, ATTP, SAP, EPCIS ) and associated challenges and risks impacting the U.S. pharmaceutical supply chain.
  • Ability to manage internal DSCSA deviation investigations through resolution and approval.
  • Ability to provide expertise and problem-solving skills for the Pharma 3PL group as it relates to DSCSA compliance. This includes receiving, order fulfilment, returns, destruction orders and new transactions as they become available.
  • Ability to effectively interface directly with clients on open issues, initiatives, and requests.
  • Requires business and application experience in warehouse operations including managing orders, inventory, warehousing, and logistics.
  • Well versed in general IT capabilities.
  • Ability to function as a resource and expert for the broader Pharma 3PL team, directly training and guiding employees on effective system operation and issue resolution
  • Strong attention to detail in business process improvements, ability to understand the end-to-end business process, and ensuring those business processes align with best practices
  • Ability to interact with the IT department on issue resolution, as well as new functionality needs
  • Proven ability to function in a self-directed environment, can manage multiple projects simultaneously
  • Must excel in a fast-paced, agile environment where critical thinking and strong problem-solving skills are required for success.

Education and Background:
  • Bachelors Degree
  • Significant experience/familiarity with relevant regulatory requirements, including federal and state regulations, Drug Supply Chain Security Act requirements, verification of trading partners, product recall execution, etc.
  • Pharmaceutical Industry background

Experience: 10+ years of related experience

Pay rate: $78-$115

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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