Director Quality Compliance

Unio Search; United States; On-site; USD 150,000 - 230,000; Full time

Job summary

Unio Search is exclusively retained by a growing digital health / clinical technology company to appoint a Director of Quality & Compliance. This is not a traditional corporate QA role; you will own the established QMS and serve as the senior day-to-day quality leader, partnering with executive leadership and teams across Clinical Operations, Product, Software Quality, Security and Client Services.

The role focuses on proactive, scalable quality, with ownership of Enterprise QMS leadership,

Qualifications

• 8+ years in Quality, Compliance or Quality Systems.
• Strong GCP / clinical research Quality experience.
• QMS, CAPA, audit and inspection experience.
• Exposure to 21 CFR Part 11 / ISO 13485 considerations.

Responsibilities

• Lead enterprise QMS leadership and continuous improvement.
• Sponsor and prepare for audits, certifications and inspections.
• Oversee CAPAs, deviations, investigations, and internal audits.
• Develop SOPs, training and management review cadence.
• Drive quality metrics, risk management and process improvements.
• Ensure compliance across GCP, 21 CFR Part 11 and medical-device expectations.

Skills

Quality leadership

Audit readiness

Regulatory affairs

Job description

Unio Search has been exclusively retained by a growing digital health / clinical technology company to appoint a Director of Quality & Compliance.

This is not a traditional corporate QA role.

You will take ownership of an established Quality Management System and become the company's senior day-to-day Quality leader, working directly with executive leadership and teams across Clinical Operations, Product, Software Quality, Security and Client Services.

The business already has a mature QMS and strong audit history. The opportunity is to take Quality to the next level, making it more proactive, scalable and embedded into how the company operates.

What you'll own:

• Enterprise QMS leadership and continuous improvement
• Sponsor/client audits, certification audits and inspection readiness
• CAPAs, deviations, investigations and internal audits
• SOPs, training and management review
• Quality metrics, risk management and process improvement
• Compliance across GCP, 21 CFR Part 11 and regulated clinical technology
• Supporting ISO 13485 / medical-device quality requirements
• Building a stronger company-wide Quality culture

The primary focus is clinical research and pharma/CRO quality. Experience with medical-device would be nice.

Who we're looking for:

You could already be a Director, or a strong Senior Manager ready for a Director-level opportunity.

We are particularly interested in people from CROs, eClinical/clinical technology, digital health, regulated SaaS or related pharma-services environments. The leadership team is highly hands-on and wants someone who will lead from the front rather than simply direct activity from a distance.

Experience Needed:

• 8+ years in Quality, Compliance or Quality Systems
• Strong GCP / clinical research Quality experience
• QMS, CAPA, audit and inspection experience
• Strong working knowledge of 21 CFR Part 11
• Exposure to ISO 13485 / medical-device regulation
• Experience working in, or alongside, a smaller or growth-stage organisation
• The ability to operate strategically while still being willing to write the SOP, lead the investigation or prepare the audit evidence yourself

You'll have unusual breadth of exposure across clinical trials, regulated software and medical devices, while working with major pharmaceutical companies, CROs and device manufacturers.

You'll also have real freedom to improve how Quality operates. The longer-term opportunity is for this person to develop into the organisation's broader Head of Quality & Regulatory leader as the company grows.