DSCSA Project Manager

HTI
SC, United States
Full-time
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PAI Pharma is the lead manufacturer and distributor of high-quality, US-made liquid and unit dose prescription and OTC pharmaceuticals.

For over 50 years, PAI has been recognized for their dedication to innovation, research, and patient care, providing essential treatments to hospitals and specialty pharmacies across the nation.

With a robust R&D center and a rapidly growing workforce, PAI has launched 21 new products in 2024 alone and continues to invest over $18 million annually in research.

Committed to being an employer of choice, PAI offers competitive pay, comprehensive benefits, and a supportive work environment.

What They Offer :

  • Full benefits package Medical, Dental, Vision, EAP, 401k Match
  • Onsite Wellness Center
  • Relocation Assistance
  • Tuition Reimbursement
  • 13 Paid Holidays + 1 Floating Holiday
  • Competitive PTO policy

What You Need :

  • Bachelor’s degree in Information Systems, Computer Science, or a related field, or an equivalent combination of education and experience.
  • Approximately 10 years of work experience, with 3-5 years in project management focused on issue resolution.
  • Experience in a production environment, with pharmaceutical experience being a significant plus due to knowledge of DSCSA, validation, and quality.
  • Knowledge and experience with ERP systems (production ERP preferred, SAP highly preferred).
  • Experience with serialization (GTIN, NDC, SSCC, etc.).
  • Technical experience working with software, XML knowledge, and EDI is a plus.
  • Ability to manage and track customer issues, gather resources, and drive improvements.
  • Candidates must be eligible to work in the U.S. without sponsorship*

What Your Role Will Look Like :

The Project Manager is responsible for tracking DSCSA compliance issues and conducting process improvement initiatives to reduce occurrence of repeat errors.

The Project Manager will design the Issue Resolution process, by collaborating with all departments that impact DSCSA. The Project Manager will also work with PAI customers to ensure they are satisfied with PAI’s efforts in compliance, and undertake joint assessments / initiatives for improving compliance, and supporting efforts to keep data integrity.

  • Track and manage customer DSCSA scorecards and issue trackers.
  • Develop and update processes for timely resolution of issues, ensuring unresolved DSCSA issues are addressed within 3 days.
  • Provide weekly compliance reports to the Senior Leadership Team (SLT) and other leaders.
  • Collaborate with various business functions to review and correct reported issues.
  • Evaluate data flow and identify improvement projects to address problem areas.
  • Execute complex project implementation tasks across multiple projects and customers.
  • Engage with customers to identify and resolve track and trace issues.
  • Work with the DSCSA onboarding team and engineers to address repeat errors or technology issues.
  • Conduct workshops and meetings to highlight issues and brainstorm process improvements.
  • Review and update SOPs to reflect process changes for better compliance.
  • Determine training needs and conduct periodic refreshers for users affecting DSCSA data.
  • Participate in shipment process improvements and identify projects to reduce errors.
  • Lead cross-functional meetings on DSCSA issue resolution and customer reviews.
  • Partner with IT resources on integration with serialization, EDI, contracts, software quality systems, and other technologies.
  • 11 days ago
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