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Climb Bio · 8 hours ago

Director, Quality Control

Wellesley, MA

Full-time

Hybrid

Director/Executive

10+ years exp

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. They are seeking a highly motivated Director of Quality Control to lead the development and execution of QC strategy, overseeing analytical activities and ensuring compliance with global regulatory requirements.

BiotechnologyHealth CareNeurosciencePharmaceutical

Responsibilities

Define and implement QC strategy aligned with company objectives and regulatory requirements

Develop phase-appropriate QC programs leveraging external manufacturing and testing capabilities

Manage and oversee all QC activities performed by third-party vendors, including in-process, release, and stability testing

Act as the primary QC liaison for CMOs/CDMOs and contract testing laboratories

Ensure timely review and approval of vendor-generated analytical data, certificates of analysis, and stability reports

Provide QC subject matter expertise for investigations, deviations, and change controls related to external testing

Oversee analytical method development, qualification, validation, and technical transfer at external sites

Review and approve comparability study designs and reports to support process changes and regulatory filings

Author and review QC sections of regulatory submissions (IND, IMPD, BLA)

Ensure external vendors comply with GMP, ICH, FDA, EMA, and other applicable guidelines

Participate in vendor audits and inspections, ensuring QC-related compliance and readiness

Establish and maintain product specifications for intermediates, drug substance and drug product

Develop stability protocols, review stability data, and recommend shelf-life for clinical trial materials

Oversee stability programs at 3rd party vendors

Partner with CMC, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of QC activities

Provide QC input for vendor selection, qualification, and ongoing performance monitoring

Drive a culture of quality and compliance across external partnerships

Identify and implement process improvements to optimize QC oversight and data integrity

Qualification

Quality ControlGMP regulationsAnalytical method developmentRegulatory submissionsVendor managementBiologic productsProblem-solvingLeadershipCommunicationCollaborationAttention to detail