Vice President, Quality (Head of Quality) – 503B 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 its Quality Management System. Reporting directly to the CEO, you will be the primary voice for patient safety, regulatory compliance, and product quality from day one through FDA inspection and commercial operation.

Key responsibilities

• Design and implement the QMS, including SOPs, batch records, deviations, 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.
• Lead sterility assurance programs: environmental monitoring, media fills, aseptic technique oversight, gowning, and cleanroom compliance (ISO 5/7/8).
• Build and manage QA, QC, and microbiology teams (12‑18 FTEs) and oversee CRO partners for method development.
• Direct validation and commissioning activities (IQ/OQ/PQ, CSV, process and cleaning validation) for equipment, utilities, HVAC, and water systems.
• Serve as the primary contact for FDA, state pharmacy board, and customer audits; lead 503B registration and inspection responses.
• Oversee investigations, root‑cause analysis, and risk management (ICH Q9).
• Qualify and audit API, excipient, and contract manufacturing suppliers.

Required profile

• 15+ years in pharmaceutical quality, with a focus on sterile manufacturing.
• 7+ years in senior quality leadership (Director, Sr. Director, VP) with budget and team responsibility.
• Hands‑on experience in a 503B outsourcing facility and direct involvement in FDA inspections.

Required skills

• eQMS, eDMS, LIMS
• Environmental monitoring, media fills, aseptic technique
• ISO 5/7/8 cleanroom compliance, contamination control
• Analytical chemistry, microbiology, method development
• IQ/OQ/PQ, CSV, process validation, cleaning validation
• 21 CFR 210/211 compliance, USP <797>, <795>, <800>, <1163>, <71>, <85>
• FDA 503B guidance, ICH Q9 risk management