Sr. Director, Quality Operations

Scorpion Therapeutics; Boston (MA); Hybrid; USD 190,000 - 250,000; Full time

Job summary

Scorpion Therapeutics in the Boston area seeks a Senior Director of Quality Operations to oversee quality for clinical and commercial cell and gene therapy products, with responsibility for external manufacturing oversight. You will shape quality strategy and ensure GMP compliance across partnerships.

You will lead regulatory readiness, coordinate audits, and manage relationships with CDMOs while mentoring the Quality Operations team and reporting to senior leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 12+ years in Quality Operations with commercial biologics or advanced therapies.
• Director-level or Senior Director-level leadership experience.
• Deep GMP knowledge (FDA, EMA, ICH).
• Experience in virtual/outsourced manufacturing and global regulatory inspections.

Responsibilities

• Provide strategic and operational leadership for external manufacturing and testing oversight, ensuring GMP/regulatory compliance.
• Manage relationships with CDMOs, contract testing labs, and logistics providers.
• Oversee product release, lot disposition, deviations, CAPAs, change controls, and investigations.
• Lead inspection readiness, participate in regulatory audits, and support filings including post-approval changes.
• Drive quality systems improvements, compliance monitoring, and governance.
• Mentor and develop the Quality Operations team and advise senior leadership.

Skills

Leadership

GMP/Regulatory Knowledge

CDMO Management

Quality Systems

Regulatory Audits

Cross-functional Partnership

Education

Bachelor's in Life Sciences or Engineering

Tools

QMS (TrackWise)

Job description

Role: Senior Director, Quality Operations at a biopharma focused on gene therapies, overseeing quality for clinical and commercial cell and gene therapy products.

Responsibilities

• provide strategic and operational leadership for external manufacturing and testing oversight, ensuring compliance with GMP and regulatory standards;
• manage relationships with CDMOs, contract testing labs, and logistics providers;
• oversee product release, lot disposition, deviations, CAPAs, change controls, and investigations;
• lead inspection readiness, participate in regulatory audits, and support filings including post-approval changes;
• drive quality systems improvements, compliance monitoring, and governance;
• mentor and develop the Quality Operations team and act as strategic quality advisor to senior leadership.

Requirements

• Bachelor’s in Life Sciences, Engineering, or related field;
• 12+ years in Quality Operations, with prior experience supporting commercial-stage biologics or advanced therapies;
• proven leadership at the Director or Senior Director level;
• deep GMP knowledge (FDA, EMA, ICH);
• experience in a virtual/outsourced manufacturing model and supporting global regulatory inspections.

Preferred: experience with autologous/allogeneic cell therapies, BLA/MAA submissions, and post-approval product lifecycle.

High-Value: expertise in biologics or cell/gene therapies, post-market quality management, GMP compliance, and regulatory interactions.

Work setup: hybrid in Somerville, MA, with onsite presence three days per week; candidates must reside within a commutable distance.