Sr. Director, Global Quality Control

Scholarrock; Cambridge (MA); On-site; USD 130,000 - 180,000; Full time

Job summary

Scholarrock, based in Cambridge, Massachusetts, is seeking a dedicated leader for their global quality control (QC) function. The role involves overseeing external QC laboratories and ensuring compliance with regulatory standards while providing strategic oversight in both clinical and commercial programs.

The ideal candidate should bring over 15 years of experience in Quality Control within the biotech or pharmaceutical industry, including substantial leadership expertise. This challenging position requires a proactive mindset and a strong commitment to mentorship and talent development within a diverse workforce.

Qualifications

• 15+ years of Quality Control and/or Analytical Sciences experience in biotech/pharma.
• 7+ years in leadership roles.
• Deep technical expertise in analytical methods for biologics.

Responsibilities

• Define and execute the global QC strategy.
• Oversee post-approval specification management.
• Ensure effective method qualification and validation.

Skills

Quality Control

Analytical Sciences

Regulatory Compliance

Leadership

Technical Troubleshooting

Education

BS/MS in a scientific discipline

Advanced degree (MS or PhD) preferred

Job description

Lead the company’s global quality control (QC) function across a fully outsourced model, overseeing external QC laboratories, contract manufacturing organizations (CMOs), and other contract partners that support both clinical and commercial programs.

Responsibilities

• Define and execute the global QC strategy, serving as the internal QC subject matter expert across analytical control strategy, compendial compliance, specification lifecycle management, and stability.
• Provide strategic oversight of stability programs, including protocol design, pull schedule governance, data review and trending, shelf‑life support, comparability assessments, and post‑approval stability commitments.
• Oversee post‑approval specification management, including revision strategy, change assessment, comparability impacts, commitment tracking, and implementation through external partners.
• Ensure effective method qualification, validation, transfer, verification, and lifecycle management across outsourced laboratories, including technical troubleshooting and issue escalation.
• Partner with Analytical Development and CMC teams to support method readiness, control strategy development, and phase‑appropriate analytical plans for new programs, process changes, and commercialization activities.
• Provide QC leadership for investigations involving OOS, OOT, non‑conforming results.
• Establish and monitor quality and operational performance expectations for external testing partners through governance forums, metrics, trend reviews, and business process oversight.
• Author, review, and approve QC‑related controlled documents, including specifications, protocols, reports, SOPs, method transfer plans, stability documents, and technical assessments as applicable.
• Build fit‑for‑purpose QC systems, governance, and internal capabilities appropriate for a virtual biotech environment, with a focus on compliance, technical rigor, and scalability.
• Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).

Qualifications

• BS/MS degree in a scientific discipline; advanced degree (MS or PhD) preferred.
• 15+ years of progressive Quality Control and/or Analytical Sciences experience in biotech/pharma industry (including outsourced operating models), with 7+ years in leadership roles.
• Deep technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including release, stability, and characterization testing.
• Strong working knowledge of USP, EP, and JP pharmacopeial requirements, and cGMP, ICH guidance, global regulatory requirements, and inspection readiness for outsourced QC operations.
• Demonstrated success leading global stability programs, including shelf‑life support, data trending, protocol governance, and regulatory commitment execution.
• Proven experience in specification development, justification, and lifecycle management, including post‑approval specification revisions and change implementation.
• Extensive experience with method transfer, qualification, validation, verification, and troubleshooting across contract testing laboratories and manufacturing partners.
• Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability.
• Strong executive presence, sound scientific judgment, and the ability to balance strategic leadership with practical execution.
• Highly proactive, decisive, and capable of independently managing key initiatives.
• Engaged people manager committed to building culture as well as mentorship and talent development.

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