Company Overview
Saol Therapeutics (pronounced “Sail”) is a specialty pharmaceutical company focused on providing therapies to patients with unmet medical needs. The company has a strategic emphasis on CNS Disorders and Rare Disease therapeutic areas. Our seasoned management team has a broad range of experience in commercialization, acquisition, licensing, formulation and product development. We are a dedicated group of professionals who have committed our life’s work to developing and bringing high-value, much-needed drugs to market. We are looking for highly-skilled individuals who are patient focused, passionate, ethical, team-oriented, and who want to help build a company that will make a difference in people’s lives.
Location
Roswell, GA (US Headquarters)
Role Overview
The Director of Quality will manage and lead the development, implementation, and continuous improvement of the Quality Management System (QMS) for molecular diagnostic medical devices. This role ensures compliance with global regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, GCP) and supports product development, manufacturing, and post-market activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Quality Systems
· Strategic Leadership:
· Develop and implement quality strategies aligned with commercial and development goals.
· Serve as the quality lead for cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain.
· Quality Systems Oversight:
· Maintain and improve Quality Management Systems (QMS) in compliance with cGMP, ICH, FDA, EMA, and other global regulatory standards.
· Oversee document control, change management, CAPA, deviation management, and training systems.
Pharmaceuticals
· Product Development Support:
· Provide quality oversight during clinical development and manufacturing activities.
· Review and approve CMC documentation for regulatory submissions were required.
· Commercial Operations:
· Ensure quality compliance of contract manufacturer and contract service organisations (CMO,CSO).
· Ensure oversight of CSOs engaged in Good Distribution Practices
Medical Device
· Maintain Design History files
· Ensure effective risk management and design control processes are in place for diagnostic products.
· Vendor management oversight of CMOs/ CSOs
GCP
KNOWLEDGE AND SKILL REQUIREMENTS:
PREFERRED SKILLS AND EXPERIENCE:
Travel Requirements
Successful Candidates Demonstrate Saol’s Values
Trustworthy – We believe that the foundation of trust is truthfulness, transparency and fairness. These principles will be the basis for all our interactions.
Focused on Patients – We will anchor our decisions with full consideration of their impact on our patients, believing that in doing what is right for them serves a higher purpose.
Passionate – We enjoy working hard, but are not one-dimensional, being curious about the world around us and striving to be continuous learners who surround ourselves with others who inspire and challenge us.
Nimble – We embrace new and promising opportunities while adjusting quickly and efficiently to the inevitability of change.
Entrepreneurial – We create value through our focus on providing solutions, drive to deliver results, and our ability to work together in solving business challenges with integrity.
Compensation
Position is a contracted role, with potential to move to a full-time role.
Apply or Learn More: email resume to: HR@saolrx.com
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