Director/Senior Director, Quality Operations (GMP)

Director/Senior Director, Quality Operations (GMP)

Company Name: MBX Biosciences, Inc.

Position Summary

MBX Biosciences is seeking a dynamic and experienced quality leader to serve as Sr. Director, Quality Operations. This highly visible role offers the opportunity to lead the Quality Operations function, driving strategic oversight of cGMP activities across MBX and its external partners. The successful candidate will be responsible for ensuring the availability of high-quality pharmaceutical products for clinical-stage programs, while fostering a culture of excellence, compliance, and collaboration. This role is ideal for a strategic and hands-on leader with deep expertise in quality oversight, regulatory compliance, and cross-functional collaboration.

Key Responsibilities

• Leads the Quality Operations function, ensuring robust oversight of cGMP activities at MBX and across external testing laboratories and manufacturing partners for both clinical and anticipated commercial products.
• Champions cross-functional collaboration with Quality Systems, Analytical Development, CMC, and Supply Chain to evolve a proactive, efficient, and compliant cGMP quality oversight system.
• Ensures full compliance with FDA, EMA, ICH, and global regulatory standards for all products released for human use.
• Directs and owns the review of batch records, product release processes, and the resolution of quality events—including complaints, deviations, investigations, and CAPAs—with a collaborative, solution-oriented mindset.
• Builds and maintains strategic partnerships with MBX’s external development and manufacturing network, resolving complex challenges while fostering continuous improvement and strong client relationships.
• Leads the qualification and requalification of CMOs, CTOs, and 3PLs, and maintains the Approved Supplier List to ensure ongoing compliance and performance.
• Serves as the key advisor on cGMP quality matters to internal project teams, MBX leadership, and external partners.
• Coordinates EU product release activities, including engagement with QPs to ensure timely and compliant execution.
• Drives inspection readiness across MBX and key contract manufacturing organizations through strategic planning and collaboration.
• Stays ahead of industry trends, regulatory updates, and emerging technologies to inform and evolve quality strategies.
• Leads continuous improvement initiatives to elevate product quality, operational efficiency, and regulatory compliance.
• Owns quality support for development activities, including contributions to regulatory submissions and filings.
• Builds and scales a high-performing Quality Operations team by defining structure, recruiting top talent.
• Other responsibilities as assigned.

Education & Qualifications

• A bachelor’s degree (advanced degree preferred) in Biology, Chemistry, Chemical Engineering, or related field.
• Minimum of 15+ years of pharmaceutical industry experience in Quality.
• Strong cGMP oversight experience for clinical and commercial stage products for drug substance and drug products, including process validation experience at 3rd party development and manufacturing partners.
• In-depth knowledge of cGMP (21 CFR Parts 210/211, EU GMP, ICH guidelines) regulations, principles, concepts, industry practices and standards. Medical device experience a plus.
• Experience in evolving cGMP related quality systems, policies and procedures to ensure compliance with current and evolving standards as well as improving the efficiency of related workflows.
• Strategic agility and leadership abilities as well as hands-on problem-solving skills.
• Leadership experience in an industry setting, with a demonstrated ability to manage multidisciplinary teams.
• Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Demonstrated excellence in leading teams and aligning cross-functional efforts. Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics.

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.