Hti - Greenville, SC

posted about 2 months ago

Full-time - Mid Level
Greenville, SC
Health and Personal Care Retailers

About the position

The Technical Project Manager at PAI Pharma plays a crucial role in ensuring compliance with the Drug Supply Chain Security Act (DSCSA) and driving process improvements within the organization. This position is responsible for tracking compliance issues related to DSCSA and implementing initiatives aimed at reducing the frequency of repeat errors. The Project Manager will design and oversee the Issue Resolution process, collaborating with various departments that impact DSCSA compliance. This role also involves direct engagement with PAI customers to ensure their satisfaction with the company's compliance efforts, conducting joint assessments, and supporting initiatives to maintain data integrity. In this role, the Technical Project Manager will track and manage customer DSCSA scorecards and issue trackers, ensuring that unresolved issues are addressed promptly, ideally within three days. The Project Manager will provide weekly compliance reports to the Senior Leadership Team (SLT) and other leaders, facilitating transparency and accountability in compliance efforts. Collaboration with different business functions is essential to review and correct reported issues, evaluate data flow, and identify improvement projects to address problem areas. The Technical Project Manager will execute complex project implementation tasks across multiple projects and customers, engaging with customers to identify and resolve track and trace issues. This includes working closely with the DSCSA onboarding team and engineers to address repeat errors or technology issues. The role requires conducting workshops and meetings to highlight issues and brainstorm process improvements, as well as reviewing and updating Standard Operating Procedures (SOPs) to reflect process changes that enhance compliance. Additionally, the Project Manager will determine training needs and conduct periodic refreshers for users affecting DSCSA data, participate in shipment process improvements, and lead cross-functional meetings focused on DSCSA issue resolution and customer reviews. The position also involves partnering with IT resources on integration with serialization, Electronic Data Interchange (EDI), contracts, software quality systems, and other relevant technologies.

Responsibilities

  • Track DSCSA compliance issues and conduct process improvement initiatives to reduce repeat errors.
  • Design the Issue Resolution process in collaboration with all departments impacting DSCSA.
  • Work with PAI customers to ensure satisfaction with compliance efforts and undertake joint assessments for improvement.
  • 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.

Requirements

  • 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.

Nice-to-haves

  • Experience in a pharmaceutical manufacturing environment.
  • Familiarity with compliance regulations and standards in the pharmaceutical industry.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.

Benefits

  • 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
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