Ass. Director GPS Quality Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Ass. Director GPS Quality Management based in the United States. This is a senior global quality leadership opportunity within a fast-growing biopharmaceutical environment focused on improving outcomes for patients with severe autoimmune diseases. The role will help ensure a robust, consistent, and effective pharmacovigilance Quality Management System across the Global Patient Safety organization. You will play a central role in audit and inspection readiness, compliance monitoring, issue management, training, and continuous improvement. The position offers significant cross-functional exposure, partnering with Quality, Safety, business partners, and stakeholders across multiple regions. You will help shape scalable processes, strengthen quality governance, and support the organization as it expands its global operations. Success will require strong regulatory expertise, excellent communication, and the ability to influence multidisciplinary teams in a complex environment. The role is remote for eligible U.S.-based candidates in the Eastern Time Zone, with comparable opportunities also available in select international locations. Lead and coordinate global pharmacovigilance audit and regulatory inspection activities, including readiness planning, preparation of documentation, team briefings, response development, and follow-up on findings. Oversee GPS issue management, deviation investigations, root-cause analysis, and CAPA activities, identifying systemic trends and implementing sustainable corrective and preventive actions. Develop, expand, and manage the global pharmacovigilance training program, including curricula, procedural training, inspection readiness, refresher programs, and training for internal teams and relevant third parties. Manage GPS procedural documentation, contributing to the development, review, maintenance, and continuous improvement of processes, procedures, and controlled documents through appropriate systems. Coordinate quality performance and compliance activities, including KPI development, evaluation, SOP compliance monitoring, and assessment of third-party contractual obligations. Support the development, implementation, and ongoing compliance monitoring of Pharmacovigilance Agreements, Safety Data Exchange Agreements, and other applicable business-partner agreements. Partner with Quality and cross-functional stakeholders to ensure pharmacovigilance requirements are consistently understood, implemented, and maintained across the organization. Help drive the continued growth and maturity of the GPS Quality Management function while providing guidance, support, and delegation to other team members. Communicate complex quality and compliance matters clearly to multidisciplinary stakeholders and contribute to continuous improvement initiatives across Global Patient Safety. Requirements: Bachelor’s degree in pharmacy, nursing, healthcare, life sciences, a technical discipline, or an equivalent combination of education and experience. At least 10 years of experience in the pharmaceutical or biotechnology industry, including a minimum of 5 years in pharmacovigilance, drug safety, or a closely related field. Proven experience establishing, managing, or improving pharmacovigilance quality systems, processes, and teams. Strong experience preparing for, hosting, and responding to global regulatory audits and inspections. Thorough knowledge of pharmacovigilance regulatory requirements and guidance across major regions, including Europe, the United States, and Japan. Expert understanding of GxP quality and compliance requirements, processes, and performance measures. Demonstrated ability to develop and implement training programs, author and review procedural documentation, and manage quality-related records. Strong analytical, organizational, planning, presentation, and written an