NPI Compliance Specialist (Biologics)

The ideal candidate will have a strong background in biologics, compliance, and new product introduction processes. As an NPI Compliance Specialist, you will play a critical role in ensuring that new biologic products are introduced in compliance with regulatory standards and internal quality requirements. You will work closely with cross-functional teams to ensure the successful launch of new products while maintaining the highest standards of quality and compliance.

Key Responsibilities:

  • Lead and manage compliance activities related to the introduction of new biologic products.
  • Develop and implement NPI compliance strategies and plans to ensure regulatory and quality requirements are met.
  • Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain to ensure seamless product introduction.
  • Conduct risk assessments and develop mitigation plans for NPI projects.
  • Ensure all NPI activities comply with applicable regulatory standards (e.g., FDA, EMA) and internal policies.
  • Prepare and review documentation required for regulatory submissions and inspections.
  • Support the development and implementation of standard operating procedures (SOPs) and work instructions for NPI processes.
  • Provide training and guidance to project teams on compliance and regulatory requirements.
  • Monitor and report on the status of NPI compliance activities to senior management.
  • Participate in regulatory inspections and audits related to NPI activities.
  • Stay current with industry trends, regulatory changes, and best practices related to biologics and NPI.


  • Bachelor's degree in Biological Sciences, Biochemistry, Biotechnology, or a related field. Advanced degree preferred.
  • Proven experience in a compliance role within the biopharmaceutical or biologics industry.
  • Strong knowledge of regulatory requirements and guidelines for biologics (e.g., FDA, EMA, ICH).
  • Experience with new product introduction processes in a biologics manufacturing environment.
  • Excellent project management skills with the ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in a cross-functional team environment.
  • Attention to detail and a commitment to quality.
  • Knowledge of GMP, GLP, and other relevant quality standards.
  • Proficiency in using compliance and project management software tools.