Job Description
Position Summary
The Vice President of Quality is responsible for implementing, managing and overseeing the MBX Quality Management System (QMS) and for leading all corporate quality strategies and ensuring compliance with global Good Practices (GxP) regulations. This role will oversee Quality Compliance, which includes audits and inspection readiness, as well as Quality Operations, Quality Systems, and Quality Assurance Validation. You will manage day-to-day operations, which involve goal setting, budgeting, hiring, and team development. In this position, you will provide effective leadership, training, and guidance to support the MBX Biosciences (MBX) Quality System and promote the MBX Quality mindset. Additionally, you will work in partnership with functional leaders and operate with an enterprise-wide perspective
Key Responsibilities
- Responsible for the strategic development and operational management of MBX’s quality program and Quality Management System and is accountable for the execution and administration of GxP Quality Unit to support Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Pharmacovigilance (GPV) Quality compliance in accordance with FDA, ICH, EMA regulations and guidelines and industry standards.
- Lead MBX’s quality function and ensure compliance with applicable internal and external regulations, standards, policies and procedures, and performance of MBX’s and contracted third party operations.
- Work collaboratively with Regulatory Affairs in the preparation, assembly and filing of regulatory submissions to support clinical trial applications and new product marketing applications, including interactions between the company and health authority representatives. Assure data integrity throughout all regulatory submissions.
- Develop and implement the overall quality strategy and vision for the laboratory operations.
- Partner with other functions to shape and execute the path from pre-IND work through commercialization in alignment with Health Authority regulations and guidance.
- Continue to build and optimize the company’s Quality Management System (QMS) to ensure that it is effectively designed, implemented and maintained to support company growth and program advancement.
- Identify critical compliance and/or business issues related to cGxP CDMOs, CROs, Contract Test Laboratories and manufacturers of critical starting materials, and for internal document and data management practices. Create and execute remediation strategies and tactical plans to address gaps.
- Drive continuous improvement within Quality and throughout MBX
- Drive major/critical deviation investigations to ensure minimal risk to product and study quality, efficacy, and safety. Collaborate with relevant functions to define root cause(s) and develop effective CAPA plans.
- Ensure the facility, processes and systems (including SOPs and associated training) are maintained in an audit- and inspection-ready state and ensure effective CAPAs are implemented to mitigate risks. Track and document CAPA effectiveness.
- Direct MBX’s quality training program. Partner with functional leadership to define curricula by function and ensure timely and documented completion of employee training.
- Recruit, develop, lead, coach and motivate a highly engaged, skilled, collaborative, and high performing Quality team. Cultivate a team culture of high standards, collaboration, empowerment, innovation, inclusion, trust, and continuous learning.
- Act as liaison with Regulatory team and takes the lead to manage all inspections by regulatory bodies.
- Define and approve the departmental budget and capital expenditures.
- Other duties as assigned.
Education & Qualifications
- Bachelor’s degree in the biological sciences or related field; Master’s degree preferred
- Minimum of 20+ years of progressive quality experience in the biopharma industry; peptides experience preferred, and experience in all clinical phases through commercial. Demonstrated leadership experience within small/virtual biopharma strongly preferred.
- Strong knowledge and ability to apply GMP, GCP, and GLP in conformance to US, EU, and ROW standards.
- A strategic thinker that can break down barriers, drive great decisions, and make an impact.
- Experience building teams, for both today and tomorrow, through focused hiring, coaching, and development.
- A resilient, inspiring and visionary Quality leader able to build a strong Quality Culture across the organization.
- Experience building and administering platform-based quality systems.
- The ability to effectively negotiate and build collaboration amongst individuals and lead cross-functional and cross-company quality initiatives.
- Expected travel 25%
Company Overview:
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. 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 MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, 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 us 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.
