Ass. Director GPS Quality Management

Accountabilities:

• 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 and verbal communication skills.
• Ability to work independently, prioritize effectively, solve problems pragmatically, and operate successfully in a global, multidisciplinary environment.
• Proven ability to influence, motivate, and collaborate with stakeholders across functions and levels of an organization.
• Professional-level proficiency with business, presentation, tracking, and quality-management systems.
• Fluency in written and spoken English.
• Candidates must be based in the United States Eastern Time Zone, Belgium, or Switzerland.

Benefits:

• Competitive annual base salary, with the locally applicable range communicated during the recruitment process for eligible international locations.
• Eligibility to participate in short-term and long-term incentive programs.
• Comprehensive rewards and benefits designed to support health, financial security, well-being, and work-life balance.
• Opportunities to work remotely depending on location, with the role available to eligible U.S.-based candidates in the Eastern Time Zone.
• International and cross-functional exposure within a growing biopharmaceutical organization.
• Opportunities to contribute to meaningful work supporting patients affected by severe autoimmune diseases.
• Inclusive, collaborative environment with opportunities for professional growth and leadership development.