Quality Director - 503B Pharma: Regulatory & QA Lead

Pinnaql; Tempe (AZ); On-site; USD 180,000 - 250,000; Full time

Job summary

Pinnaql is seeking a Quality Director to lead the Quality organization for a 503B outsourcing facility. You will establish, maintain, and continuously improve the QMS to ensure compliant manufacturing, testing, release, and distribution of compounded drug products.

The role requires strategic leadership over QA and QC, deviation management, CAPA, change control, and audits, with collaboration across Operations, Regulatory, and Leadership teams. Onsite, with travel as needed.

Qualifications

• Bachelor’s degree in a scientific field; advanced degree preferred.
• Minimum 8–10 years in pharmaceutical quality, QA, QC, or regulatory compliance.
• 3–5 years of leadership experience managing quality teams.

Responsibilities

• Develop, implement, and continuously improve the QMS for a 503B outsourcing facility.
• Ensure compliance with FDA cGMP, Federal FD&C Act provisions, USP standards, and state regs.
• Serve as primary Quality representative during FDA inspections and audits.
• Oversee QA and QC for sterile and non-sterile operations, deviations, CAPA, change control, and document control.
• Review batch records, lab results, investigations, and final product disposition.
• Lead regulatory inspection preparation and inspection readiness.
• Provide quality guidance for facility expansions, validation, and tech implementations.
• Lead QA/QC personnel and foster a culture of quality and patient safety.
• Support recalls, adverse events, and regulatory reporting as needed.

Skills

FDA cGMP knowledge

USP <797>/<800> compliance

Quality Management System

Quality Assurance & QC

Investigations & CAPA

Regulatory inspections

Leadership

Cross-functional collaboration

eQMS proficiency

Documentation control

Audits

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related

Advanced degree (MS, PharmD, or related)

Tools

eQMS software

Microsoft Office Suite

Job description

Pinnaql is seeking a Quality Director to lead the Quality organization for a 503B outsourcing facility. You will establish, maintain, and continuously improve the QMS to ensure compliant manufacturing, testing, release, and distribution of compounded drug products.

The role requires strategic leadership over QA and QC, deviation management, CAPA, change control, and audits, with collaboration across Operations, Regulatory, and Leadership teams. Onsite, with travel as needed.