Director, External & CMC Quality Assurance

Scholar Rock, Inc.; Cambridge (MA); On-site; USD 200,000 - 260,000; Full time

Job summary

Scholar Rock seeks an experienced Director of Quality Assurance to support External and CMC Quality Assurance. You will oversee external partner governance for manufacturing, testing and release of biological products, and collaborate with CMC teams to maintain quality systems and ensure inspection readiness.

The role requires leadership in quality, risk management, and a proactive approach to drive continuous improvement across clinical and commercial programs.

Qualifications

• 5+ leader-level experience in Quality or related functions
• Strong knowledge of GMP/GxP requirements and regulatory expectations
• Experience overseeing external manufacturers and testing labs
• Experience with biologics in clinical and/or commercial stages

Responsibilities

• Provide QA oversight over Drug Substance manufacturing across multiple CMOs.
• Oversee deviations, investigations, CAPAs, change controls, testing, and disposition decisions.
• Design a robust product disposition program for clinical and commercial materials.
• Maintain inspection readiness across outsourced operations and support health authority inspections.
• Monitor partner quality performance using metrics and governance forums.
• Assess quality risk for process changes, deviations, investigations, tech transfer, and supply continuity.
• Offer strategic guidance on quality requirements for lifecycle activities including clinical and commercial supply.
• Promote a culture of quality and proactive issue identification across stakeholders and partners

Skills

GMP/GxP knowledge

Regulatory expectations

Quality leadership

Communication skills

Strategic execution

Education

BS/MS in scientific discipline

Job description

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical 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 about our neuromuscular franchise 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 Assurance to support External and CMC Quality Assurance. This role will provide oversight of external partner (Contract Organization) governance for the manufacturing, testing, and release of biological products. This position will work cross-functionally with the CMC teams (Manufacturing, QC, MSAT, etc) and the external partners. This role is responsible for managing quality system records (change control, deviations, product complaints, batch disposition, etc.) and quality risk management to deliver product for clinical and/or commercial purposes. This role will also be responsible for advancing a strong quality culture for proactive issue identification and a state of inspection readiness. This position reports to the Sr. Director, External & CMC Quality Assurance.

Position Responsibilities

• Provide Quality Assurance oversight over Drug Substance manufacturing of GxP biological product. This involves oversight of multiple CMOs as part of a complex supply chain that includes contract laboratories and other critical service providers.
• Provide QA oversight of deviations, investigations, CAPAs, change controls, testing, product impact assessments, and disposition-related decisions.
• Design and maintain a robust, scalable product disposition program for clinical trial material as well as commercial products across multiple markets.
• Ensure continuous inspection readiness across outsourced operations and support health authority inspections, partner inspections, and due diligence activities.
• Monitor partner quality performance through defined metrics, scorecards, and governance forums; identify trends and proactively elevate compliance or execution risks.
• Partner cross-functionally to assess quality risk associated with process changes, deviations, investigations, comparability activities, tech transfer, and supply continuity issues.
• Provide strategic guidance on quality requirements for product lifecycle activities, including clinical supply, commercial readiness, distribution, complaints, and post-approval changes.
• Drive a culture of quality, accountability, and proactive issue identification across internal stakeholders and external partners.

Candidate Qualifications

• BS/MS degree in a scientific discipline.
• 12+ years of experience in the pharmaceutical/biotech industry (including meaningful experience in outsourced/virtual operating models), with 5+ years in leadership roles within Quality or related functions
• Strong working knowledge of GMP/GxP requirements, FDA/EMA expectations, ICH guidance, and risk-based quality management principles.
• Demonstrated success overseeing external manufacturers, testing laboratories, suppliers, and quality service providers.
• Experience supporting biologics products across both clinical and/or commercial stages; demonstrated success driving continuous improvement.
• Strong communication skills, sound scientific judgement, and the ability to balance strategic thinking with hands-on execution.
• Highly proactive, decisive, and capable of independently managing key initiatives in a fast-paced commercial readiness and launch environment.
• Engaged leader committed to building a strong quality culture through collaboration and mentorship.

$200,000 - $260,000 a year

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .