Senior Quality and Compliance Manager

Meditrial is looking for an experienced professional capable of managing Quality and Compliance activities for GCP/GVP and FDA BIMO Compliance, maintenance of ISO 9001:2015, ISO 13485:2016, ISO 27001:2022, ISO 27701:2019 certifications and to provide compliance expertise together with the clinical department to ensure compliance across all Meditrial projects. Additionally, the position will be responsible for implementing clinical compliance plans to include external audits of clients, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures. The role will report to the Chief Medical Officer and Global Head of Regulatory and Quality. The Position is office-based in our office in down-town Minneapolis. Responsibilities Formulate GCP compliance strategy and provide advice for all programs within Meditrial Assess GCP and GVP compliance risk areas and develop and implement risk mitigation measures. Develop and prioritize an audit strategy for all programs Plan and lead GVP and GCP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories and all clients to determine compliance status and identify compliance risks Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented Partner with Clinical Development, Clinical Operations, Nonclinical and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP and GVP regulatory requirements and expectations Manage QA reviews of project-related of essential clinical study documents Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any Lead GCP/GVP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies Develop and implement standards, policies, and procedures for GCP/GVP regulatory compliance Report and elevate compliance issues to management, including requests for directed audits Participate in quality and compliance improvement initiatives within and outside of Clinical Development/Clinical Operations departments Provide guidance, interpretation and information on GCP and GVP regulations, standards and quality systems Prepare internal QA reports, provide input for external partners/ clients Preferred Experiences & Requirements BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred 8 to 10 years of relevant pharmaceutical industry experience, with a minimum of 5 years of GCP compliance, preferably in an FDA regulated environment Experience in the large pharmaceutical industry and start up environment preferred In-depth knowledge of and ability to interpret and apply GCL, GVP, EU, FDA and ICH regulations, guidelines, and best practices Experience in planning and conducting GCP and GVP audits Experience with regulatory inspections and inspection readiness (EU experience is a plus) Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs) Experience reviewing and auditing study-related documentation (e, g, nonclinical and clinical study reports, Investigator’s Brochures) Strong team player with a demonstrated track record of success in a cross-functional team and fast-moving environment. Excellent organizational, computing and oral/written communication skills Ability to influence and negotiate effective solutions Strong critical thinking and decision-making skills Ability to travel up to 20% Personal Skills Ability to communicate, problem solve and work effectively in an international team Innovative and self-motivated Good organization skills and ability to prioritize goals and responsibilities Ability to negotiate and communicate with clients in a professional manner Proficient computer skills with the ability to understand and assess technology alternatives and implication for current processes Ability to be productive and successful in a dynamic work environment #J-18808-Ljbffr Meditrial