Director of Manufacturing Validation

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company dedicated to meeting patient needs across oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With an array of marketed products and an expansive pipeline, our mission is to expedite the discovery, research, and development of innovative therapies to deliver new treatments to patients more swiftly. Job Overview We are looking for a passionate and experienced professional to join our Global Technology and Quality organization as the Director of Manufacturing Validation. In this pivotal role, you will ensure that our validation programs meet global compliance standards for our development and commercial product portfolio, particularly focusing on small molecule solid dosage forms. You will operate using a Lifecycle Validation model and oversee the implementation and updates of Validation Master Plans for all GMP programs. The ideal candidate will demonstrate autonomy while thriving in a collaborative and fast-paced team environment, showcasing strong initiative and professionalism. Key Responsibilities Develop and implement robust validation strategies, programs, and continuous improvement initiatives. Sustain policies and procedures that uphold a compliant Lifecycle Validation model to support development programs and ongoing commercial manufacturing activities. Establish and maintain Validation Master Plans for all projects. Lead and facilitate technical transfer activities, ensuring compliance and proper validation. Collaborate with global cross-functional teams and external CMOs to apply necessary validation policies. Drive process characterization and conduct statistical evaluations of complex parameters across all programs. Ensure compliant validation of equipment qualification, process development, and ongoing process verification, among other tasks. Plan, design, and execute key regulatory submission projects utilizing sound methodologies and thorough assessments. Monitor process performance and manage change controls at both internal and CMO sites. Contribute as a lead author for pertinent sections in regulatory submissions. Engage actively in all validation activities for commercial products. Collaborate with cross-functional product development teams as needed. Perform additional duties as assigned. Core Competencies Thorough understanding of the CMO landscape and associated capabilities. Expertise in Good Manufacturing Practices (GMPs) and industry standards. Strong analytical and problem-solving skills with proficiency in statistical analysis. Able to work effectively in a global, cross-functional team environment across different locations and time zones. Excellent interpersonal skills to influence internal and external stakeholders positively. Outstanding organizational abilities to manage multiple complex projects simultaneously. Exceptional written and verbal communication skills. Proficient in Microsoft Office tools and similar applications. Commitment to fostering collaborative leadership and a professional, respectful work culture. Education and Experience A minimum of 10-15 years of relevant experience in the biotech or pharmaceutical industry is required (or 8-12 years with a Master's degree). A validation background across multiple therapeutic modalities (including API, solid dosage, biologics, gene therapies) is essential. Familiarity with EMA and FDA validation requirements, especially the Lifecycle Model, is expected. Lean Six Sigma certification is preferred. The base salary range for this role is $173,200 to $216,500, and is part of our total rewards package, which includes merit-based salary increases, incentive plan participation, 401(k) access, and comprehensive insurance options. Our generous time-off policy comprises flexible paid time off, paid holidays, and sick time. Total compensation will vary depending on experience, skills, education, and other factors permitted by law. Confidentiality and Compliance All information encountered is confidential, and compliance with applicable regulatory, legal, and operational procedures is expected. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Mental/Physical Requirements This role requires working in a fast-paced environment with multiple demands, necessitating sound judgment, high initiative, and independence, alongside efficient use of a personal computer. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to any protected characteristics by law.

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