Quality Compliance Manager

2 days ago


Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Title: Quality Compliance Manager

At Vivex Biologics Inc., we are seeking a highly skilled Quality Compliance Manager to join our team. This role plays a crucial part in ensuring the highest levels of quality and compliance across all aspects of our HCT/P manufacturing processes and Quality Management Systems.

Key Responsibilities:
  • Manage and monitor Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Complaints, Planned Deviations, and Error Corrections.
  • Ensure compliance of the Change Control Program and provide oversight to the development, revision, and maintenance of Quality processes, procedures, and metrics.
  • Lead a team of quality coordinators and specialists, collaborating with cross-functional departments to maintain and enhance the quality management systems to meet regulatory requirements and industry best practices.
  • Provide technical guidance and ensure adherence to non-conformance, CAPA, complaints, planned deviation, and error correction procedures.
  • Support Regulatory Affairs in the completion of supplier qualifications and audits.
Requirements:
  • Bachelor's degree in engineering or a related technical/scientific discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
  • At least 8-10 years of experience in related Engineering or Quality role. Supervisory experience preferred.
  • Experience with validations preferred.
  • Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
  • Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
  • Experience with Non-Conformance, Planned Deviation, Complaint, and Corrective and Preventive Actions (CAPAs).
  • Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
  • Effective oral, written, communication, and presentation skills.
  • Strong organizational and communication skills.
  • Strong analytical and problem-solving skills.
  • Project management skills preferred.
  • Ability to be assertive and influence others and lead significant change.
  • American Society for Quality (ASQ) certification preferred.
  • Certified Tissue Bank Specialist (CTBS) certification preferred.
Working Conditions:

Must be willing to accommodate travel if necessary. Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.

Physical requirements: While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.



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