Quality & Regulatory Leader – Pharma & Medical Devices

Confidential; Scottsdale (AZ); On-site; USD 150,000 - 210,000; Full time

Job summary

Confidential is seeking a Head of Quality and Regulatory to provide strategic and operational leadership for quality assurance, quality control, and regulatory compliance across pharmaceutical products and imaging systems. This on-site, full-time role will drive QMS development and ensure compliance with FDA, EMA, ISO, GMP, and GCP standards.

You will lead quality and regulatory teams, manage deviations and CAPAs, oversee regulatory submissions, and partner with senior leadership to embed

Qualifications

• Bachelor’s degree or advanced degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field.
• Extensive experience in pharmaceutical and/or medical device quality and regulatory environments with direct regulatory exposure.
• Strong knowledge of GMP, GCP, and relevant quality standards.
• Experience developing, implementing, and maintaining Quality Management Systems.
• Proven leadership of quality and regulatory teams and audits.
• Experience managing regulatory submissions, approvals, registrations, and related documentation.

Responsibilities

• Lead development and continuous improvement of the QMS across pharmaceutical products and medical devices.
• Maintain quality policies, procedures, standards, and objectives for FDA/EMA/ISO compliance.
• Oversee QA and QC activities including product testing, release, and monitoring.
• Lead regulatory compliance activities, including submissions and registrations.
• Represent the company during regulatory inspections and audits.
• Develop internal and external audit programs; manage CAPAs and deviations.
• Collaborate with cross-functional teams to mitigate quality and regulatory risks.
• Monitor quality metrics to identify risks and opportunities for improvement.
• Provide strategic guidance on evolving regulatory requirements.

Skills

Analytical thinking

Problem solving

Communication skills

Leadership

Education

Bachelor’s degree or advanced degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field

Tools

QMS (Quality Management System)

Job description

Confidential is seeking a Head of Quality and Regulatory to provide strategic and operational leadership for quality assurance, quality control, and regulatory compliance across pharmaceutical products and imaging systems. This on-site, full-time role will drive QMS development and ensure compliance with FDA, EMA, ISO, GMP, and GCP standards.

You will lead quality and regulatory teams, manage deviations and CAPAs, oversee regulatory submissions, and partner with senior leadership to embed