Quality Assurance Compliance Leader

2 weeks ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Overview

Purpose of the Role

The Quality Compliance Manager is integral in upholding the highest standards of quality and regulatory adherence throughout our HCT/P manufacturing operations and Quality Management Systems. This position is chiefly responsible for overseeing and managing Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Complaints, Planned Deviations, and Error Corrections. Additionally, the role encompasses the management and compliance oversight of the Change Control Program. By supervising the creation, modification, and upkeep of Quality processes, procedures, and metrics, the Manager guarantees alignment with current site SOPs, Corporate Policies, and applicable regulations. The position also involves coordinating efforts among staff to address quality challenges and enhance operational efficiency.

Key Responsibilities

  • Lead the Quality Compliance team by organizing schedules, delegating tasks, setting priorities, establishing deadlines, and conducting performance evaluations.
  • Initiate and support improvement initiatives in collaboration with operational departments to mitigate, prevent, and minimize deviations.
  • Provide expert guidance and ensure compliance with non-conformance, CAPA, complaints, planned deviation, and error correction protocols.
  • Act as a functional leader, collaborating cross-functionally to deliver quality and regulatory insights across all organizational areas.
  • Direct quality planning efforts to assess existing and develop new measurement systems aimed at enhancing departmental performance.
  • Assist in change control processes by offering expert reviews and feedback to ensure adherence to relevant procedures and regulations.
  • Support remediation initiatives and implement controls to maintain improvements.
  • Collaborate with Regulatory Affairs to facilitate supplier qualifications and audits.
  • Offer guidance on regulatory compliance, change control, quality assurance, and risk management practices.
  • Ensure compliance with all federal, state, company, and regulatory body regulations, policies, and procedures.
  • Mentorship: Guide and mentor the Quality Compliance team to achieve set objectives and deliver exemplary results, fostering a culture of technical excellence and innovation.
  • Provide both technical and administrative support to direct and indirect reports.
  • Report project progress to senior Quality Leadership and cross-functional steering committees as necessary.

Qualifications

  • A Bachelor's degree is required, preferably in engineering or a related technical/scientific field (e.g., Biology, Chemistry). A Master's degree is preferred.
  • 8-10 years of experience in a related Engineering or Quality role is required, with supervisory experience preferred.
  • Experience with validations is preferred.
  • Strong understanding of FDA, AATB, and cGTP guidelines is preferred.
  • Experience in the Tissue Banking, Pharmaceutical, Medical Device, or Biologics sectors is advantageous.
  • Familiarity with Non-Conformance, Planned Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) is essential.
  • Proficient in relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
  • Excellent oral, written, communication, and presentation skills are required.
  • Strong organizational and analytical abilities, coupled with problem-solving skills.
  • Project management skills are preferred.
  • Ability to assertively influence others and lead significant change initiatives.
  • American Society for Quality (ASQ) certification is preferred.
  • Certified Tissue Bank Specialist (CTBS) certification is preferred.

Working Conditions

Willingness to travel as necessary. The role is primarily office-based, with access to laboratory environments and occasional clean room settings, involving exposure to human tissue and associated hazards.

Physical Requirements

While performing the duties of this position, the employee is regularly required to sit for extended periods. The employee may occasionally need to pull, lift, or move up to 20 pounds.

Direct Reports

Quality Compliance Coordinator; Quality Compliance Specialist

This job description does not restrict management's right to assign or reassign duties and responsibilities at any time.

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and 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 employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

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

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