Senior Director, Quality Control - Seven-Day Lab Leader

ElevateBio; Waltham (MA); On-site; USD 240,000 - 330,000; Full time

Job summary

ElevateBio’s Senior Director of Quality Control will lead a multi‑site QC organization at the Waltham facility, ensuring safe, compliant, and predictable testing and release activities across seven days. You will drive capacity planning, staffing, and continuous improvement while partnering with Manufacturing and Quality Assurance to meet client and business commitments.

The role requires deep GMP QC leadership experience in biopharma, strong data integrity practices, and a track record of

Qualifications

• Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, Engineering, or related field; advanced degree preferred.
• At least 15 years of progressive GMP Quality Control or analytical lab operations with leadership of managers and multi-functional teams.
• Experience leading QC in biopharmaceuticals, biologics, cell or gene therapies or other regulated manufacturing.

Responsibilities

• Lead the integrated QC organization, operating model, objectives, decision rights, talent strategy, and capability roadmap.
• Ensure seven‑day coverage, facilities, equipment, and systems align with demand.
• Oversee product release, in‑process testing, environmental and microbiological monitoring, raw material disposition, stability, and samples management.
• Drive seven‑day operations via capacity planning, schedule control, and performance reviews.
• Partner with Manufacturing to align readiness and rapid execution of STAT in‑process samples.
• Promote right‑first‑time execution, efficient review and reporting, backlog control, and continuous improvement.
• Provide leadership for QCAT, method transfer, validation, lifecycle management, and digital QC.
• Ensure QC activities meet cGMP, procedures, specs, data integrity, and regulatory commitments.
• Represent QC in audits, regulatory inspections, and client governance, communicating performance and recovery plans clearly.

Skills

Quality leadership

GMP knowledge

Analytical testing

Education

Bachelor’s degree in Biology or related

Job description

ElevateBio’s Senior Director of Quality Control will lead a multi‑site QC organization at the Waltham facility, ensuring safe, compliant, and predictable testing and release activities across seven days. You will drive capacity planning, staffing, and continuous improvement while partnering with Manufacturing and Quality Assurance to meet client and business commitments.

The role requires deep GMP QC leadership experience in biopharma, strong data integrity practices, and a track record of