Director, External – CMC Quality Assurance

Scholar Rock

. Provide Quality Assurance oversight over Drug Substance manufacturing of GxP biological products across multiple CMOs, contract laboratories, and critical service providers.

Posted 10/8/2026full-timeCambridge • Massachusetts • United StatesLead💰 $200,000 - $260,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Quality Assurance for Drug Substance manufacturing, with a strong focus on GMP/GxP compliance, risk management, and oversight of external partners in the pharmaceutical and biotech industries.

Highest-signal resume keywords

GMP/GxP ComplianceQuality Risk ManagementLeadership in Quality FunctionsBiologics Product OversightStrategic Quality Guidance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Assurance OversightDeviation ManagementCAPA ManagementChange ControlProduct Impact AssessmentInspection ReadinessQuality Metrics MonitoringContinuous ImprovementTechnical TransferSupply Continuity

Soft Skills

Strong Communication SkillsSound Scientific JudgementProactive Decision-MakingCollaborationMentorship

Industry Keywords

Pharmaceutical IndustryBiotech IndustryFDA ExpectationsEMA ExpectationsICH GuidanceOutsourced Operating ModelsClinical SupplyCommercial ReadinessQuality CultureGovernance Forums

About the role

Key responsibilities & impact

Provide Quality Assurance oversight over Drug Substance manufacturing of GxP biological products across multiple CMOs, contract laboratories, and critical service providers.
Oversee deviations, investigations, CAPAs, change controls, testing, product impact assessments, and disposition-related decisions.
Design and maintain a scalable product disposition program for clinical trial material and 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 metrics, scorecards, and governance forums; identify trends and escalate compliance or execution risks.
Partner cross-functionally to assess quality risks related to process changes, deviations, investigations, comparability, tech transfer, and supply continuity.
Provide strategic guidance on quality requirements for 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.
Work cross-functionally with CMC teams and external partners; manage quality system records and quality risk management.
Report to the Sr. Director, External & CMC Quality Assurance.

Requirements

What you’ll need

BS/MS degree in a scientific discipline.
12+ years of experience in the pharmaceutical/biotech industry, including meaningful experience in 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 principles.
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, sound scientific judgement, and 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 leadership committed to building a strong quality culture through collaboration and mentorship.