Director, Global Quality GMP Processes

divh2Director, Global Product Quality, Gmp Processes/h2pThe director, global product quality, gmp processes is a strategic leadership role responsible for benchmarking, standardizing, and optimizing global quality processes across the organization. This role ensures that product quality systems are aligned with good manufacturing practices (gmp) and regulatory requirements while driving efficiency, consistency, and continuous improvement across all regions and product lines. The director will lead global initiatives to harmonize and enhance processes related to product quality complaints, deviations, capa, and management reporting, ensuring timely and effective resolution and robust compliance./ph3Key Responsibilities/h3ulliGlobal process ownership: lead the design, implementation, and continuous improvement of global quality processes for:/liulliProduct quality complaints/lilicorrective and preventive actions (capa)/lilideviations/lilimanagement reporting and trending/li/ulliBenchmarking

best practices: evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency./liliGmp compliance: ensure all quality processes meet global regulatory requirements (e.g., fda, ema, pmda) and align with current gmp standards./liliGovernance

standardization: develop and enforce global standards, sops, templates, and tools to ensure consistency across all manufacturing sites and affiliates./liliQuality systems leadership: oversee the global deployment and optimization of electronic quality systems (e.g., trackwise), including configuration, training, and validation./liliCross-functional collaboration: partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies./liliData-driven insights: in collaboration with quality operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making./liliTeam leadership: build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence./li/ulh3Qualifications/h3prequired:/pullibachelors degree in a scientific discipline (e.g., chemistry, biology, pharmaceutical sciences); advanced degree preferred./liliminimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role./lilideep understanding of gmp regulations and global regulatory requirements (e.g., 21 cfr parts 210, 211, 820)./liliproven experience in managing global quality systems and optimizing complaint, capa, and deviation processes./lilistrong analytical and problem-solving skills with a data-driven mindset./liliexcellent communication, leadership, and stakeholder management skills./liliproficiency in quality management systems (e.g., trackwise) and microsoft office tools./liliability to travel internationally as needed./li/ulppreferred:/pullibasic understanding of artificial intelligence and advanced analytics/liliexperience supporting risk management programs or frameworks./lilifamiliarity with quality management systems and digital tools./li/ulh3Competencies/h3paccountability for results - stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change./ppstrategic thinking

problem solving - make decisions considering the long-term impact to customers, patients, employees, and the business./pppatient

customer centricity - maintain an ongoing focus on the needs of our customers and/or key stakeholders./ppimpactful communication - communicate with logic, clarity, and respect. influence at all levels to achieve the best results for otsuka./pprespectful collaboration - seek and value others perspectives and strive for diverse partnerships to enhance work toward common goals./ppempowered development - play an active role in professional development as a business imperative./ppminimum $183,335.00 - maximum $274,160.00, plus incentive opportunity: the range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the united states. other elements may be used to determine actual pay such as the candidates job experience, specific skills, and comparison to internal incumbents currently in role. typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. this information is provided to applicants in accordance with states and local laws./ppapplication deadline: this will be posted for a minimum of 5 business days./ppcompany benefits: comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death

dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits./p/div