Quality Site Head

TITLE: Quality Site Head
TYPE: Direct Hire
LOCATION: Apex, NC
ONSITE/REMOTE/HYBRID: Onsite
START DATE: January 2026

The Vanguard Utility Corporation is launching a new FDA-registered 503B outsourcing facility in Apex, North Carolina, built on a clear foundation. This role calls for a leader who treats quality as a promise, not a department. The Quality Site Head owns the integrity of the operation and the safety of the patients it serves, leading all site quality functions and standing front and center during FDA and Board of Pharmacy inspections.

In a growing 503B environment, this leader sets the bar for disciplined execution, clear systems, and real accountability. They communicate with regulators confidently, make sound scientific decisions under pressure, and drive teams toward solutions, not excuses. This is a hands‑on leader who builds trust, pushes progress, and expects quality work to get done every day without compromise.

Regulatory Interface and Inspection Readiness

• Lead FDA and Board of Pharmacy inspections and maintain continuous inspection readiness.
• Communicate clearly and confidently with regulators, grounded in strong 503B knowledge.

SOP Governance and Master Control Oversight

• Own SOP governance in Master Control, ensuring procedures align with daily operations.
• Partner with Compliance Insight while retaining internal ownership of quality decisions.

Quality Systems Leadership

• Lead all site quality functions including QA, QC, Microbiology, Validation, Environmental Monitoring, Calibration, and Document Control.
• Direct investigations, CAPAs, OOS/OOTs, change control, batch release, and risk assessments with sound scientific judgment.

Operational Partnership and Lab Build‑Out Oversight

• Provide quality oversight for lab build‑out, equipment placement, and GMP workflow design.
• Partner cross‑functionally to embed quality‑first decisions into site operations.

Training Oversight and Workforce Readiness

• Own site training programs and Master Control tracking for competency and compliance.
• Ensure all employees remain qualified with no gaps impacting quality or patient safety.

Leadership, Culture, and Site Ambassadorship

• Serve as the on‑site extension of the Head of Quality with credibility and clarity.
• Build a culture of accountability, practical problem solving, and consistent execution.

Required

• Bachelor's degree in Chemistry preferred. Biology or related scientific disciplines are considered.
• Ten plus years of Quality leadership in pharmaceutical manufacturing with strong sterile or aseptic experience.
• Proven ability to lead regulatory inspections and maintain inspection readiness.
• Deep understanding of 503B outsourcing facility requirements and modern GMP expectations.
• Experience managing external consultants while ensuring internal ownership of all quality decisions.

Preferred

• Advanced scientific degree.
• Experience supporting lab setup, equipment qualification, and workflow development.
• Background in growth‑stage or rapidly scaling pharmaceutical operations.

We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.