Senior Director Quality Assurance

3 days ago

Greenville, South Carolina, United States HTI Full time $120,000 - $250,000 per year

Position Summary

The Senior Director of Quality Assurance Systems provides strategic and operational leadership for the company's global GxP Quality Management System across manufacturing, packaging, laboratories, warehouses, IT, and external partners. This position ensures compliance with all applicable regulations, maintains inspection readiness, and drives continuous improvement in quality performance and systems.

Key Responsibilities

Leadership & Oversight

  • Lead Quality System functions including
    Document Control, External Quality, and Quality Systems
    teams.
  • Develop, mentor, and retain staff through effective coaching, clear performance goals, and succession planning.
  • Foster a
    quality-driven culture
    emphasizing accountability, collaboration, and continuous improvement.
  • Coordinate cross-functional communication with Manufacturing, R&D, Supply Chain, and Regulatory Affairs to ensure quality alignment.

Quality Systems & Compliance

  • Oversee implementation, maintenance, and improvement of the company's
    global GxP Quality Management System
    .
  • Ensure inspection readiness through
    internal audit management, CAPA effectiveness, and regulatory inspection support
    .
  • Direct the
    document control system
    , ensuring lifecycle management and data integrity.
  • Lead
    Quality Council
    and
    Change Approval Board (CAB)
    processes for risk assessment, change control, and supplier approval.
  • Maintain
    approved supplier listings
    , oversee
    vendor audits
    , and ensure quality agreements are current.
  • Review and approve deviations, risk assessments, and product disposition decisions.

Strategic & Continuous Improvement

  • Establish and track
    quality metrics
    , identify trends, and lead corrective or preventive actions.
  • Manage
    Quality Risk Register
    and prioritize remediation plans.
  • Drive improvement initiatives to enhance quality system performance and operational efficiency.
  • Stay current with
    FDA, EMA, and ICH regulations
    , providing leadership in adapting systems to evolving standards.

Qualifications

Education:

  • Bachelor's degree in a science or engineering discipline required.
  • Advanced degree (MS, PhD, or MBA) preferred.

Experience:

  • Minimum
    15 years in the pharmaceutical industry
    with at least
    10 years in a senior quality leadership role
    .
  • Broad QA experience across
    auditing, investigations, complaints, cGxP systems, and commercialization support
    .
  • Direct experience with
    FDA inspections and regulatory agency interactions
    .
  • Proven ability to develop, implement, and sustain compliant, efficient quality systems.
  • Experience managing
    External Quality
    (CMO, suppliers) preferred.

Skills & Attributes:

  • Expert understanding of
    FDA, ICH, and cGMP regulations
    .
  • Strong leadership, decision-making, and conflict resolution skills.
  • Excellent communication and presentation abilities.
  • Proven ability to
    lead cross-functional teams
    and influence at all organizational levels.
  • Strategic thinker with a practical, results-oriented approach.

Work Environment

  • On-site leadership role in a regulated manufacturing and laboratory environment.
  • Occasional travel required for audits, inspections, and external quality oversight.

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