Associate Director, Quality Systems

Position Summary

MBX Biosciences is seeking an Associate Director of Quality Systems to join our growing quality organization. This individual is responsible for leading the development, implementation, and continuous improvement of quality systems to ensure compliance with applicable regulatory requirements and industry standards. This role oversees key quality system elements, including CAPA, change control, document management, training, and internal audits. This individual will work cross-functionally to drive a culture of quality, operational excellence, and risk-based decision-making. This position plays a critical leadership role in supporting inspection readiness, maintaining regulatory compliance, and fostering continuous improvement across the organization.

Key Responsibilities

• Supports the build of continuous improvement to the Quality System to ensure regulatory and industry standards are met.
• Act as the business owner for MBX’s newly implemented eQMS.
• Provides strong guidance, interpretation, and information pertaining to current GMPs, GCPs and GLPs to apply updates to the Quality System including SOPs, Policies and Specifications.
• Supports GxP training in functional areas and contributes to the development of appropriate training for internal and external personnel.
• Contributes to the overseeing, evaluation, and selection of GxP Service Providers.
• Devises external audit schedule, oversees execution of audit plans and audits, reviews audit reports, and tracks corrective/preventive actions associated with key sites and contract service providers in accordance with applicable regulations, guidelines and MBX SOPs.
• Manages deviations, CAPAs, product complaints, and change controls per the MBX Quality Management System.
• Ensure that all required aspects of the Quality Management System are trended on a routine basis for presentation to senior management for review
• Manages the internal audit programs.
• Provides key support for Inspection Readiness programs.
• Other responsibilities as assigned.

Education & Qualifications

• Bachelor’s degree with 10+ years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems managerial roles, GLP and GCP experience a plus.
• Possess in-depth knowledge of GMP/GLP/GCP regulations, principles, concepts, industry practices and standards.
• Experience in managing and leading eQMS
• Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
• Understanding of domestic and international regulatory requirements.
• Outstanding communication skills (interpersonal, verbal and written).
• Prior experience with Health Authority Inspections.
• Strong leadership and management skills.
• Excellent teamwork and collaboration skills.
• Excitement about the vision and mission of MBX.

Company Overview

MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs, and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

EEO Statement:

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.