12+ years in the pharmaceutical/biotech industry, with 5+ years in leadership roles in Quality or related functions.
Strong knowledge of GMP/GxP requirements and FDA/EMA expectations.
Proven experience managing external manufacturers and quality service providers.
Experience with biologics products in clinical and commercial stages, focusing on continuous improvement.
Excellent communication skills and sound scientific judgment.
Proactive and decisive, capable of managing initiatives in a fast-paced environment.
Engaged leader focused on building a strong quality culture.
Responsibilities
Provide QA oversight for Drug Substance manufacturing of GxP biological products across multiple CMOs.
Oversee deviations, investigations, CAPAs, change controls, and product impact assessments.
Design and maintain a scalable product disposition program for clinical and commercial products.
Ensure continuous inspection readiness and support health authority inspections.
Monitor partner quality performance and escalate compliance risks as needed.
Assess quality risk associated with process changes and supply continuity issues.
Provide strategic guidance on quality requirements for product lifecycle activities.
Drive a culture of quality and proactive issue identification across teams.
Benefits
Opportunity to work in a dynamic and collaborative environment.
Engagement in meaningful projects that impact product quality and patient safety.
Access to professional development and mentorship opportunities.
Involvement in cross-functional teams that enhance career growth.
Contribution to a strong quality culture within the organization.
Full Job Description
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 escalate 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
About Scholar Rock Holding Corporation
Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company that focuses on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company's proprietary platform technology is based on the use of growth factor-binding proteins to selectively inhibit the activation of these signaling pathways in a variety of tissues. Scholar Rock's lead product candidate, SRK-015, is a highly specific inhibitor of the activation of the growth factor myostatin, which is involved in the regulation of muscle mass. The company is headquartered in Cambridge, Massachusetts and was founded in 2012.
