Head of Quality
About Climb:
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus, and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.
At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We are seeking a highly motivated Head of Quality. This role will initially report to the CEO. As Head of Quality you will lead all quality assurance activities, ensuring compliance with regulatory standards and overseeing quality operations for the company. This is an exciting opportunity to shape and grow the Quality function at small and growing organization.
Key Responsibilities:
- Develop, implement, and oversee the company’s Quality Management System (QMS).
- Ensure compliance with FDA, EMA, and other relevant regulatory guidelines.
- Oversee quality operations including GMP, GLP, and GCP compliance for clinical-stage biologics.
- Lead internal audits and manage external audits of clinical sites, laboratories, and CDMOs/CROs.
- Partner cross-functionally with clinical, regulatory, and manufacturing teams to align on quality initiatives.
- Provide strategic input into regulatory filings and support interactions with health authorities for inspection readiness.
- Conduct risk assessments and implement corrective and preventive action plans (CAPAs).
- Develop and deliver quality training for employees and external partners.
Qualifications:
- Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
- 10+ years of quality assurance experience in biotechnology/pharmaceutical industry, including experience in phase 1 through commercialization.
- Prior experience in senior level quality role within a biotechnology company
- Expertise in biologics is preferred
- Comprehensive knowledge of regulatory requirements (FDA, EMA) and quality guidelines (ICH, GMP, GCP, GLP).
- Demonstrated leadership in managing quality assurance functions and QMS.
- Experience conducting and managing audits and inspections.
- Exceptional problem-solving and communication skills, and the ability to operate in a collaborative and fast-paced environment.
This position will be based out of our Wellesley, MA office. Base salary offered may vary depending on the individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.
Qualified candidates are encouraged to forward their resumes to [email protected]
Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.