Quality Systems & Compliance Specialist
About The Position
MBX Biosciences is seeking a highly motivated Quality Systems & Compliance Specialist to oversee and continuously enhance key elements of the Quality Management System (QMS), including Document Control, GxP Training, and Service Provider Lifecycle Management. This individual will play a critical role in ensuring compliance with applicable regulatory requirements, supporting inspection readiness activities, and partnering cross-functionally to maintain effective and sustainable quality processes across the organization. The ideal candidate is detail-oriented, collaborative, and experienced in quality system management within a regulated biotechnology or pharmaceutical environment.
Requirements
- Bachelor's degree in a scientific, technical, or related discipline.
- Minimum of 4 years of experience within biotechnology, pharmaceutical, medical device, or other regulated industries.
- Minimum of 3 years of experience managing quality system processes.
- Experience supporting Document Control, GxP Training, and/or Service Provider Quality programs.
- Experience working with electronic Quality Management Systems (eQMS).
- Strong knowledge of GMP, GLP, GCP, and applicable global regulatory requirements.
- Experience supporting regulatory inspections, audits, and inspection readiness programs.
- Excellent organizational, communication, and problem-solving skills.
- Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
Nice To Haves
- Experience in a clinical-stage biotechnology company.
- Experience implementing or enhancing quality systems and process improvements.
- Experience with supplier and service provider qualification and oversight programs.
- Working knowledge of risk-based quality management principles.
Responsibilities
- Own and maintain the Document Control and GxP Training programs.
- Manage document review, approval, issuance, revision, periodic review, and archival processes.
- Oversee training curricula, assignments, compliance monitoring, and training effectiveness.
- Provide oversight for Service Provider Lifecycle Management.
- Support service provider qualification, approval, monitoring, and requalification activities.
- Maintain the Approved Service Provider List, annual audit schedule, and supporting records.
- Develop, revise, review, and approve quality system procedures and controlled documents.
- Ensure assigned quality systems comply with applicable GxP regulations and company procedures.
- Monitor quality system metrics and identify process improvement opportunities.
- Support eQMS administration for assigned processes.
- Support internal audits, inspections, and inspection readiness activities.
- Assess regulatory changes and implement required updates.
- Provide training and guidance on assigned quality system processes.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
