New · posted Oct 15
Scholar Rock · Biotechnology
Director, External & CMC Quality Assurance
- Cambridge, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
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.
What you need
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.
What you'll do
- 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.
Pay
$200,000 – $260,000 a year
Employer providedWhere you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAEqual opportunity, accessibility and legal noticesScholar Rock's statements, word for word
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $260,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Scholar Rock's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Scholar Rock's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- GMP and compliance5
- Lab testing and methods4
- Investigations and CAPA4
- Quality systems and risk4
- Documentation and SOPs1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Scholar Rock on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Regulatory2 50%
- Quality2 50%
By level
- Director3 75%
- VP & Executive1 25%
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Director, External & CMC Quality Assurance at Scholar Rock
Open until filled. $200K–$260K a year, employer provided.