Head of Quality Control

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

The Head of Quality and Regulatory will provide strategic and operational leadership for quality assurance, quality control, and regulatory compliance across the company’s pharmaceutical products and imaging systems. This full-time, on-site position.

The Head of Quality and Regulatory will be responsible for developing, implementing, and maintaining robust Quality Management Systems (QMS) that meet applicable pharmaceutical, medical device, and regulatory requirements. This role will oversee quality systems, regulatory submissions, audits, inspections, product release, compliance activities, and continuous improvement initiatives across manufacturing and distribution operations.

The successful candidate will partner closely with cross-functional and senior leadership teams to establish quality standards and policies, manage deviations and CAPAs, identify and mitigate quality and regulatory risks, and ensure products consistently meet internal specifications and applicable regulatory requirements. This role will also lead and develop quality and regulatory personnel, serve as a key company representative during regulatory inspections, and provide strategic guidance on evolving regulatory requirements.

Role Responsibilities

• Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) across pharmaceutical products and medical devices.
• Establish and maintain quality policies, procedures, standards, and objectives to ensure compliance with FDA, EMA, ISO, GMP, GCP, and other applicable regulatory requirements.
• Oversee Quality Assurance and Quality Control activities, including product testing, specifications, product release, and ongoing quality monitoring.
• Lead regulatory compliance activities, including the preparation and management of regulatory submissions, approvals, registrations, and ongoing product compliance requirements.
• Serve as the primary quality and regulatory representative during FDA, international regulatory, customer, and third-party inspections and audits.
• Develop and oversee internal and external audit programs and ensure timely identification, investigation, and resolution of compliance gaps.
• Establish and manage processes for deviations, nonconformances, investigations, corrective and preventive actions (CAPA), change control, and quality risk management.
• Partner with Manufacturing, Operations, Engineering, Supply Chain, R&D, and other cross-functional teams to identify and mitigate quality and regulatory risks.
• Monitor and analyze quality metrics, trends, and performance data to identify risks, opportunities for improvement, and areas requiring corrective action.
• Lead continuous improvement initiatives that strengthen quality systems, improve operational performance, and maintain regulatory compliance.
• Ensure quality and regulatory requirements are integrated into manufacturing, distribution, and product lifecycle processes.
• Develop, review, and approve SOPs, quality policies, technical documentation, regulatory documentation, and other controlled quality records.
• Monitor changes in applicable regulations, standards, and industry expectations and develop strategies to ensure continued compliance.
• Establish and oversee quality and regulatory training programs to ensure employees understand and consistently follow applicable requirements.
• Recruit, develop, mentor, and lead quality and regulatory personnel while fostering a culture of accountability, compliance, and continuous improvement.
• Provide senior leadership with strategic guidance regarding quality risks, regulatory requirements, compliance initiatives, and emerging industry developments.
• Collaborate with senior leadership to establish quality objectives and ensure quality and regulatory considerations are incorporated into business and operational decisions.

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, including direct experience with FDA, EMA, ISO, and other applicable regulatory requirements.
• Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant pharmaceutical and medical device quality standards.
• Demonstrated experience developing, implementing, and maintaining Quality Management Systems.
• Proven experience leading Quality Assurance and Quality Control functions, including product testing, release, specifications, and compliance activities.
• Demonstrated experience planning for, managing, and participating in regulatory inspections and internal, external, and third-party audits.
• Strong understanding of quality systems, including deviations, nonconformances, investigations, CAPA, change control, and risk management.
• Experience preparing, managing, or overseeing regulatory submissions, approvals, registrations, and related documentation.
• Proven leadership experience managing, mentoring, and developing quality and/or regulatory teams.
• Strong analytical and problem-solving skills, with the ability to interpret complex quality data, assess risk, and make evidence-based decisions.
• Excellent written and verbal communication skills, with the ability to develop clear and accurate policies, SOPs, regulatory documentation, and executive-level communications.
• Demonstrated ability to influence and collaborate effectively with cross-functional and senior leadership teams.
• Professional certifications in quality, regulatory affairs, or a related discipline are preferred.