Founding VP of Quality - 503B Sterile Manufacturing

Friday Plans; Kansas; On-site; USD 220,000 - 360,000; Full time

Job summary

Friday Plans is seeking the founding Head of Quality to lead the build of our QMS and serve as the primary FDA contact for our new 503B facility in Kansas City, KS.

You will own quality from SOP #1 through the first FDA inspection and beyond, reporting to the CEO. This builder role requires hands-on 503B outsourcing experience and the ability to assemble QA, QC, and microbiology teams to ensure patient safety and product quality as we scale.

Qualifications

• 15+ years in pharmaceutical quality, focused on sterile manufacturing.
• 7+ years in senior quality leadership with budget and team accountability.
• Direct, hands-on 503B outsourcing facility experience — non-negotiable.
• Track record as the senior quality rep during FDA inspections; managed 483s, Warning Letters, or state board deficiencies through to resolution.
• Built or substantially rebuilt a QMS — greenfield or major remediation experience preferred.
• Deep working knowledge of 21 CFR 210/211, USP <797>/<795>/<800>/<1163>, and FDA 503B guidance.

Responsibilities

• QMS Design & Build — SOPs, batch records, deviations, CAPA, change control, OOS, complaints, document control.
• Sterility Assurance — environmental monitoring, media fills, aseptic technique oversight, gowning, ISO cleanroom compliance.
• QC Laboratory — lead analytical chemistry and microbiology teams; manage CROs for method development while keeping release testing in-house.
• Validation & Commissioning — IQ/OQ/PQ, CSV program, cleaning validation across dosage forms.
• FDA & Regulatory Leadership — primary FDA contact, lead initial 503B registration and inspections.

Skills

Sterile manufacturing

Quality leadership

503B outsourcing experience

FDA inspections

QMS design/build

Regulatory knowledge (CFR/USP)

Education

Bachelor’s in Pharmaceutical Sciences, Chemistry, Pharmacy, Engineering, or related

Job description

Friday Plans is seeking the founding Head of Quality to lead the build of our QMS and serve as the primary FDA contact for our new 503B facility in Kansas City, KS.

You will own quality from SOP #1 through the first FDA inspection and beyond, reporting to the CEO. This builder role requires hands-on 503B outsourcing experience and the ability to assemble QA, QC, and microbiology teams to ensure patient safety and product quality as we scale.