Director of Validation for Manufacturing Operations

Join Sumitomo Pharma Co., Ltd., a leading global pharmaceutical company committed to addressing patient needs in critical areas such as oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With an innovative pipeline of therapies, we strive to expedite research and development of groundbreaking treatments for patients. Learn more about our impactful work and core values. Job Overview We are looking for a driven and experienced professional to fill the role of Director of Validation for Manufacturing Operations. This key position is part of our Global Technology and Quality organization. The selected candidate will lead a comprehensive validation program for our development and commercial products, primarily focusing on small molecule solid dosage forms. This role is crucial for ensuring that our operations comply with a Lifecycle Validation model, which includes maintaining and updating Validation Master Plans for all GMP programs. The ideal candidate will demonstrate strong initiative and possess the ability to work both independently and collaboratively in a dynamic environment. Upholding confidentiality and adhering to the highest standards of professionalism and ethics is essential. Key Responsibilities Enhance and contribute to strategies, programs, and continuous improvement initiatives related to validation. Develop and maintain policies and procedures that support a compliant Lifecycle Validation model for both development and commercial activities. Establish and manage Validation Master Plans for all SMPA projects, ensuring consistent execution. Lead and support technical transfer activities with a focus on validation and compliance. Exhibit strong leadership within cross-functional teams involving internal resources and external partners to implement necessary validation policies. Collaborate globally to advance process characterization, variability assessments, and statistical evaluations across all programs. Ensure compliance in validation activities, including equipment qualification, process development, and cleaning validation. Plan and execute critical NDA/MAA projects through thorough design and risk assessments. Monitor process and product performance, overseeing change controls and deviations at internal sites and CMOs. Act as the lead author for relevant sections in regulatory submissions. Engage in all validation activities related to commercial products, including regulatory starting materials and drug products. Participate as a vital member of SMPA's cross-functional product development teams. Perform additional duties as assigned. Core Competencies Thorough understanding of CMO capabilities and limitations. In-depth knowledge of Good Manufacturing Practices (GMPs). Expertise in manufacturing principles and standards. Strong analytical and problem-solving abilities. Ability to work effectively across global teams and time zones. Excellent interpersonal skills that positively influence others. Exceptional organizational skills with the ability to manage multiple complex projects simultaneously. Proficiency in Microsoft Office applications. A commitment to collaborative leadership and fostering a professional culture based on trust. Education and Experience Applicants should possess a minimum of 10-15 years of relevant experience in the biotech or pharmaceutical industry, or 8-12 years with a Master's degree. Validation experience with multiple therapeutic modalities is required. Familiarity with EMA and FDA validation requirements is essential. Lean Six Sigma training or certification is preferred. The base salary for this role ranges from $173,200 to $216,500, and is part of our total rewards package that includes merit-based increases and comprehensive benefits. Enjoy flexible paid time off, 11 holidays, and additional time off during the last week of December. Mental/Physical Requirements Successful candidates must navigate a fast-paced environment, exercise sound judgment, and communicate effectively, both in writing and verbally, while utilizing a personal computer. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to any characteristic protected by law.

Created: 2026-03-04