VIVOS HOLDINGS

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Manager Quality Assurance

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Position Summary

The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing environment. This position provides final quality review and disposition decisions for raw materials, in-process materials, and finished goods, ensuring products meet established specifications, regulatory requirements, and customer expectations.

This role operates with a high degree of autonomy and decision-making authority, serving as a primary Quality leader for the site. The Manager, Quality Assurance is responsible for ensuring effective implementation of cGMP requirements (21 CFR Parts 210/211), maintaining inspection readiness, and supporting a proactive quality culture focused on risk mitigation and continuous improvement.

The position serves as a primary Quality representative for contract manufacturing customers, owning quality communications, documentation, and audit readiness.

Key Responsibilities

Quality System Ownership & Decision Authority

  • Own and maintain assigned quality systems, including but not limited to deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition
  • Provide final quality review and release/disposition decisions for materials and finished products
  • Exercise independent decision-making authority for routine and non-routine quality events, ensuring compliance with cGMP and customer requirements
  • Escalate significant quality risks (e.g., recall risk, critical events) in accordance with established procedures

Manufacturing Quality Oversight

  • Provide QA oversight of liquid fill manufacturing operations to ensure compliance with cGMPs, internal procedures, and customer-specific requirements
  • Support real-time decision-making on the production floor related to deviations, non-conforming materials, and process issues
  • Ensure effective execution of in-process controls and finished product inspection requirements

Contract Manufacturing Quality Leadership

  • Serve as the primary Quality representative for assigned contract manufacturing customers
  • Lead customer quality discussions, governance meetings, and issue resolution calls independently
  • Own all customer quality communications, including:
    • Deviations and investigations
    • Complaint responses
    • Customer notifications and regulatory commitments
  • Prepare and review customer-specific documentation, including:
    • Questionnaires and technical requests
    • Specifications and supporting quality data
    • Audit responses and follow-up documentation
  • Lead and/or support customer audits, ensuring transparency, professionalism, and inspection readiness

Compliance & Regulatory Oversight

  • Ensure compliance with applicable regulatory requirements, including FDA, EPA, DNR, ATF, and OSHA
  • Maintain inspection readiness at all times; support and lead regulatory inspections and customer audits
  • Ensure adherence to data integrity principles (ALCOA+) across all quality systems and documentation
  • Ensure consistent and compliant application of site procedures and quality standards

Investigation & Risk Management

  • Lead and approve investigations, including OOS, OOT, deviations, and nonconformances
  • Ensure robust root cause analysis and implementation of effective corrective and preventive actions
  • Monitor and trend quality data to identify emerging risks and drive proactive improvements
  • Apply risk-based decision making consistent with ICH Q9 principles

Validation & Change Control Oversight

  • Ensure validation programs comply with regulatory requirements and internal procedures
  • Oversee quality impact assessments and approvals within the change control system
  • Ensure appropriate evaluation of changes for regulatory, product quality, and customer impact

Leadership & Personnel Management

  • Directly supervise and develop quality personnel, including both hourly and salaried employees
  • Ensure effective training, qualification, and ongoing development of staff
  • Provide performance management, coaching, and leadership to drive a high-performing quality organization
  • Foster a culture of accountability, ownership, and continuous improvement

Operational Support & Continuous Improvement

  • Partner cross-functionally with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance
  • Drive continuous improvement initiatives to enhance product quality, reduce variability, and improve efficiency
  • Support site quality metrics and ensure alignment with business and customer expectations
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