Director, External & CMC Quality Assurance
Director-level QA role at a biotech developing muscle-targeted therapies: provides quality assurance oversight of external manufacturers (CMOs) and contract labs for biologics manufacturing, testing, and batch disposition, while managing deviations, CAPAs, change control, quality risk, and inspection readiness across clinical and commercial supply chains.
- Compensation
- $200K–$260K / yr
- Location
- Cambridge, MA
- Work setup
- Hybrid
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 5+ years
- Category
- Qa
- Posted
Skills
Must have
- BS/MS degree in a scientific discipline
- 12+ years of experience in the pharmaceutical/biotech industry, including outsourced/virtual operating models
- 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
- Demonstrated success overseeing external manufacturers, testing laboratories, suppliers, and quality service providers
- Experience supporting biologics products across clinical and/or commercial stages
- Demonstrated success driving continuous improvement
- Strong communication skills and sound scientific judgement
- Highly proactive, decisive, and capable of independently managing key initiatives in a fast-paced commercial readiness/launch environment
- Engaged leader committed to building a strong quality culture through collaboration and mentorship
Full 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 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.