Vice President, Quality (Head of Quality) – 503B Outsourcing Facility

About the role

Friday Plans is building a new 503B outsourcing facility in Kansas City and needs a senior quality leader to design and launch the quality system from day one. Reporting directly to the CEO, you will be the founding head of Quality, responsible for patient safety, regulatory compliance, and the overall quality culture.

Key responsibilities

• Design and implement the QMS, including SOPs, batch records, deviation handling, CAPA, change control, OOS, complaints, and document control.
• Ensure compliance with 21 CFR 210/211, USP <797>, <795>, <800>, <1163>, <71>, <85> and FDA 503B guidance.
• Select and deploy electronic QMS, DMS and LIMS solutions.
• Lead sterility assurance programs: environmental monitoring, media fills, aseptic technique oversight, gowning, and ISO 5/7/8 clean‑room compliance.
• Build and manage analytical chemistry and microbiology laboratories, including CRO partnerships for method development while keeping release testing in‑house.
• Oversee validation and commissioning (IQ/OQ/PQ) of equipment, utilities, HVAC, water systems, and CSV programs.
• Serve as primary liaison with FDA, state pharmacy board, and customer auditors; lead 503B registration, pre‑approval inspections and any 483/Warning Letter responses.
• Direct investigations, root‑cause analysis and risk management (ICH Q9) for all deviations.
• Qualify and audit API, excipient, contract lab and CMO suppliers.
• Recruit, develop and lead the founding QA, QC and microbiology teams (12‑18 FTEs at steady state).

Required profile

• 15+ years of pharmaceutical quality experience, primarily in sterile manufacturing.
• 7+ years in senior quality leadership roles (Director, Sr. Director, VP) with budget and team responsibility.
• Hands‑on experience operating a 503B outsourcing facility and leading FDA inspections.
• Proven track record managing 483s, Warning Letters or state board deficiencies to resolution.

Required skills

• QMS design and implementation.
• CAPA, deviation, change control, OOS and complaint handling.
• Regulatory knowledge: 21 CFR 210/211, USP <797>/<795>/<800>, FDA 503B guidance.
• eQMS, eDMS, LIMS platforms.
• Environmental monitoring, media fills, aseptic technique, ISO 5/7/8 cleanroom standards.
• Analytical chemistry and microbiology laboratory management.
• Equipment and process validation (IQ/OQ/PQ), CSV.
• FDA liaison and audit leadership.
• Root‑cause investigation, risk management (ICH Q9).
• Supplier qualification and audit.