Director, Global Quality GMP Processes

Director, Global Product Quality, Gmp Processes

The 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.

Key responsibilities :

• Global process ownership : lead the design, implementation, and continuous improvement of global quality processes for :
• Product quality complaints
• Corrective and preventive actions (capa)
• Deviations
• Management reporting and trending
• Benchmarking & best practices : evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency.
• Gmp compliance : ensure all quality processes meet global regulatory requirements (e.g., fda, ema, pmda) and align with current gmp standards.
• Governance & standardization : develop and enforce global standards, sops, templates, and tools to ensure consistency across all manufacturing sites and affiliates.
• Quality systems leadership : oversee the global deployment and optimization of electronic quality systems (e.g., trackwise), including configuration, training, and validation.
• Cross-functional collaboration : partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies.
• Data-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.
• Team leadership : build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence.

Qualifications : Required :

Preferred :

Competencies :

Salary range : minimum $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 candidate's 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.

Application deadline : this will be posted for a minimum of 5 business days.

Company 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.