Quality Assurance - Manager

We are seeking a Quality & Regulatory Compliance Specialist to ensure the maintenance and effectiveness of the Quality Management System (QMS) and regulatory adherence at our facility. Key Responsibilities Include Maintaining compliance with Good Distribution Practices (GDP), local, state, and federal regulations (DEA, FDA, OSHA, etc.), and corporate policies.Acting as the primary liaison with regulatory agencies, managing inspections, investigations, and information requests.Conducting Quality, Safety, Security, and Regulatory assessments to promote a culture of quality and compliance.Supporting the development and implementation of QMS components such as CAPA, risk management, change control, and training programs.Monitoring metrics, analyzing trends, and reporting performance to drive continuous improvement and cost savings.Ensuring proper documentation and compliance of controlled substances, including inventory counts, Schedule 2 order forms, and reporting to authorities.Overseeing facility security, health & safety programs, and managing security vulnerabilities.Participating in audits, maintaining licensure, and managing regulatory documentation. Qualifications And Skills Bachelor’s degree in Life Science, Business, or related field, with at least four years of relevant experience.Process-oriented with knowledge of Lean Six Sigma, regulatory laws, and drug distribution practices.Effective communication, training, leadership, negotiation, and organizational skills.Strong analytical, problem-solving, and decision-making abilities, with proficiency in Microsoft Office. This role is onsite in Shakopee, MN, with flexibility required based on business needs. Up to 10% travel may be necessary.