Quality Compliance Manager

4 weeks ago

Miami, United States VIVEX BIOLOGICS INC Full time
Job DescriptionJob DescriptionDescription:

Job purpose


The Quality Compliance Manager plays a crucial role in ensuring the highest levels of quality and compliance across all aspects of our HCT/P manufacturing processes and Quality Management Systems. The Quality Compliance Manager is primarily responsible for managing and monitoring Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Complaints, Planned Deviations, and Error Corrections. The role is also responsible for managing, monitoring, and ensuring compliance of the Change Control Program. By providing oversight to the development, revision, and maintenance of Quality processes, procedures, and metrics, the Manager ensures compliance with current site SOPs, Corporate Policies, and regulations. Coordinates activities for staff to resolve quality issues and improve efficiency. Responsible for leading a team of quality coordinators and specialists and collaborating with cross-functional departments to maintain and enhance the quality management systems to meet regulatory requirements and industry best practices. The Quality Compliance Manager is also expected to provide support to the Regulatory Affairs team by providing guidance with standards and regulations requirements for supplier qualifications, certifications and licensing, and audits.


Duties and responsibilities

  • Lead Quality Compliance team by managing schedules, assigning, and prioritizing their workload, establishing due dates, and completing their performance reviews.
  • Initiate, lead, and/or support improvement projects together with operational departments to address, prevent, and reduce deviations.
  • Provide technical guidance and ensures adherence to non-conformance, CAPA, complaints, planned deviation, and error correction procedures.
  • Serve as a functional leader while working cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.
  • Lead quality planning activities to evaluate existing and develop new measurement systems to assess and improve departmental output.
  • Support change control activities by providing expert review and feedback ensuring compliance with applicable procedures and regulations.
  • Supports remediation efforts and implements controls to sustain improvements.
  • Support Regulatory Affairs in the completion of supplier qualifications and audits.
  • Provide guidance on regulatory compliance, change control, quality control, and risk management practices.
  • Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures.
  • Mentor and guide Quality Compliance team that meets agreed objectives and delivers best practice results, promoting excellence, and fostering a culture of technical excellence and innovation.
  • Provides technical and administrative support and guidance to direct and indirect reports.
  • Reports out on project progress to senior Quality Leadership and cross functional steering committees, as appropriate.
Requirements:

Qualifications

  • Bachelor’s degree required, preferably in engineering or a related technical/scientific discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred. Master’s degree 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.


Direct reports

Quality Compliance Coordinator; Quality Compliance Specialist

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.


Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

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