Senior Quality Director - FDA-Regulated Ops & QMS

Pinnaql, Inc.; Tempe, Northern (AZ, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Pinnaql, Inc. is seeking an experienced Quality Director to lead the Quality organization for a 503B outsourcing facility.

You will establish, maintain, and continuously improve the Quality Management System (QMS) to ensure products meet FDA, cGMP, USP, and state requirements while safeguarding patient safety. In this pivotal role, you will oversee QA and QC activities, drive CAPA, change control, deviations, and supplier qualification, and partner with cross-functional teams to sustain

Qualifications

• Bachelor's degree in Pharmacy or related field required.
• Advanced degree (MS/PharmD) preferred.
• 8–10 years of pharmaceutical quality experience (QA/QC or regulatory) or equivalent.
• 3–5 years in a leadership role managing quality teams.
• Experience supporting FDA-regulated operations, preferably 503B/sterile compounding.
• Proven track record in regulatory inspections and audits.
• Experience implementing or improving pharmaceutical quality systems.
• Experience with aseptic processing, environmental monitoring, and validation programs.

Responsibilities

• Lead the Quality organization and maintain the QMS for a 503B outsourcing facility.
• Ensure compliance with FDA cGMP, USP standards, and state regulations.
• Represent QA during FDA inspections, client audits, and regulatory assessments.
• Oversee QA/QC activities for sterile or non-sterile compounding operations.
• Develop and maintain audit programs for internal and supplier operations.
• Lead inspection readiness and regulatory reporting activities.
• Drive continuous improvement and quality culture across the organization.
• Collaborate with Operations, Engineering, and Leadership on risk mitigation.

Skills

FDA cGMP

QA/QC leadership

Regulatory inspections

Cross-functional leadership

eQMS proficiency

Problem solving

Education

Bachelor's in Pharmacy or related

Advanced degree (MS/PharmD) preferred

Tools

eQMS

Job description

Pinnaql, Inc. is seeking an experienced Quality Director to lead the Quality organization for a 503B outsourcing facility.

You will establish, maintain, and continuously improve the Quality Management System (QMS) to ensure products meet FDA, cGMP, USP, and state requirements while safeguarding patient safety. In this pivotal role, you will oversee QA and QC activities, drive CAPA, change control, deviations, and supplier qualification, and partner with cross-functional teams to sustain