Sr. Manager, Quality Systems

Climb Bio•Wellesley, MA

9h•Hybrid

About The Position

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 systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy 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 believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate. They reflect our commitment to patients, each other, and the pursuit of transformative science. We are seeking a highly motivated Senior Manager, Quality Systems. The Senior Manager, Quality Systems will be responsible for developing, implementing, and maintaining robust GxP-compliant Quality Systems in a dynamic biotech startup environment. This role focuses on hands-on execution and subject matter expertise in electronic quality management systems supporting GMP, GCP, and GLP activities. The position ensures compliance with global regulatory requirements and drives continuous improvement initiatives to support the company’s mission of delivering innovative therapies. This position reports to the VP of Quality.

Requirements

Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
8+ years of experience in Quality Assurance/Quality Systems within biotech or pharmaceutical industry.
Strong knowledge of GxP regulations (GMP, GCP, GLP) and electronic quality systems.
Expertise in Veeva Systems, preferred.
Excellent communication, organizational, and problem-solving skills.
High attention to detail and commitment to data integrity.
Experience in a startup or fast-paced environment is highly desirable.

Responsibilities

Serve as business owner for GxP quality management systems (eDMS/QMS/LMS).
Design, implement, and maintain processes for document control, training, quality events, CAPA, change control, and risk management across GxP functions.
Author and maintain site policies, SOPs, and documentation to support GxP compliance.
Act as Subject Matter Expert for eDMS, templates, and MS Word formatting.
Administer Learning Management System (LMS): curriculum creation, scheduling, reporting, and technical support.
Ensure data integrity and compliance within all electronic systems.
Drive continuous improvement initiatives to enhance system efficiency and effectiveness.
Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness.
Participate in internal and external audits as needed.
Provide QA support for deviations, CAPAs, effectiveness checks, change controls, investigations (OOS/OOT), and risk assessments.
Lead investigation/CAPA triage meetings and collaborate with functional groups to ensure timely resolution and metric compliance.
Support Quality Management Review Program by tracking and trending data for system performance and improvements.
Generate reports and dashboards to monitor GxP system performance, compliance, and training effectiveness.
Prepare summaries and recommendations for senior management.
Foster a quality mindset across the organization through risk-based and innovative decision-making.
Act as a trusted advisor to internal teams, providing compliance guidance and facilitating timely resolution of quality issues.
Assist with clinical batch disposition activities, including review and quality oversight of CMOs.
Review batch data such as batch records, deviations, in-process data, environmental monitoring data, QC release testing, and other applicable quality systems to determine acceptability for product disposition.