Director, Global Quality Systems and Compliance

Requirements

• BS/MS degree in a scientific discipline.
• 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
• Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
• Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
• Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
• Hands-on experience with systems such as Veeva Vault is preferred.
• Highly proactive, decisive, and capable of independently managing key initiatives.

Additional Information

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Summary of Position: Scholar Rock is seeking an experienced and motivated Director of Quality Systems and GxP Compliance. Reporting to the Senior Director, Global Quality Systems and Compliance, this position will oversee aspects of quality systems and regulatory compliance across commercial, clinical, and development activities. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at scholarrock? Share your experience