Overview
Head of Quality Assurance Jobs in United States at Skills Alliance
Title: Head of Quality Assurance
Company: Skills Alliance
Location: United States
Confidential Opportunity
Head of Quality
US-Based | Radiopharmaceuticals | Confidential Client
The Opportunity
Our client is an innovative organisation building the next generation of infrastructure supporting the radiopharmaceutical industry. Following significant investment and expansion plans, they are seeking to appoint their first senior Quality leader to establish and lead the Quality function for a rapidly growing business.
This is a unique opportunity to join at an early stage and play a pivotal role in designing the Quality Management System, shaping the quality culture, and supporting the development of future manufacturing operations. Reporting directly to executive leadership, the successful individual will become a key member of the leadership team and will help influence the long-term quality strategy as the organisation scales.
This position is ideally suited to someone who enjoys building rather than maintaining systems, thrives in entrepreneurial environments, and is excited by the opportunity to make a lasting impact.
Key Responsibilities
- Build, implement and continuously improve the company’s Quality Management System (QMS) in preparation for commercial manufacturing activities.
- Establish quality policies, procedures and governance frameworks aligned with FDA, NRC, GMP and applicable global regulatory requirements.
- Develop and maintain inspection readiness across the organisation, ensuring a proactive quality culture.
- Partner closely with Manufacturing, Technical Operations, CMC, Regulatory Affairs, Supply Chain and executive leadership to embed quality into all operational activities.
- Lead quality strategy for technology transfer, manufacturing readiness and future commercial operations.
- Oversee quality oversight of internal operations and external manufacturing partners, suppliers and contract organisations.
- Establish and manage deviation, CAPA, change control, risk management, complaint handling and document management systems.
- Support regulatory inspections, customer audits and health authority interactions.
- Recruit, develop and mentor the future Quality organisation as the business expands.
- Serve as the senior Quality representative on the leadership team, providing strategic guidance while remaining operationally engaged.
Ideal Background
Candidates are likely to bring:
- Significant Quality leadership experience within biotechnology, pharmaceuticals or radiopharmaceuticals.
- Strong working knowledge of GMP regulations, quality systems and inspection readiness.
- Experience supporting commercial manufacturing or late-stage clinical manufacturing operations.
- Hands-on experience implementing or significantly enhancing Quality Management Systems.
- Experience working closely with manufacturing, technical operations, CMC and regulatory functions.
- Experience supporting technology transfer, process validation and commercial readiness activities.
- Previous experience within a high-growth biotech, emerging organisation or entrepreneurial environment is highly desirable.
- Radiopharmaceutical, nuclear medicine, sterile manufacturing or other highly regulated manufacturing experience would be advantageous.
The Individual
The successful individual will be:
- A hands-on leader who enjoys building organisations from the ground up.
- Comfortable operating with ambiguity while establishing structure and processes.
- Highly collaborative with strong communication and stakeholder management skills.
- Pragmatic, solutions-oriented and capable of balancing compliance with operational delivery.
- Passionate about developing high-performing teams and fostering a strong quality culture.
- Motivated by the opportunity to influence business strategy as part of a small executive leadership team.
Why This Opportunity?
Unlike many established organisations, this role offers the opportunity to create rather than inherit. The successful candidate will have significant influence over how the Quality function evolves, supporting the establishment of future manufacturing operations while helping shape the culture, infrastructure and long-term success of an organisation positioned for substantial growth.
This is an opportunity for an experienced Quality leader who enjoys solving complex challenges, building teams, and making a visible impact within a fast-moving, highly innovative environment.
