About Made Scientific
Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors.
Position Summary
Made Scientific is seeking a highly motivated Digital Systems Quality Engineer Manager to support GMP manufacturing operations for cell therapy programs. This role will be responsible for establishing, leading, and continuously improving the quality oversight of GxP digital systems supporting clinical development/operations, data management and automation areas at Made Scientific. This role ensures that computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations. This position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key site GxP systems. The position will serve as the QA lead for Computer Software Validation (CSV) lifecycle documents, IT Change Control facilitation and QA review of CSV documents.
Key Responsibilities
Quality Management & Compliance
- Oversee processes related to QMS, IT Change Control, Computerized System Validation, and Data Integrity for electronic systems
- Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders
- Perform QA oversight for IT systems used in GMP environments, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems.
- Ensure deployed solutions align with business needs and Data Integrity requirements
- Work with project teams and business/quality representatives to ensure compliance with regulatory requirements (FDA, EMEA, PMDA, etc.)
- Provide support during regulatory inspections and internal audits
- Evaluate vendor validation packages, SOC reports, and system documentation to ensure regulatory alignment
Computer System Validation & Software Lifecycle
- Provide oversight for the implementation and validation of GxP software applications, modules, and associated interfaces per internal procedures
- Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders
Stakeholder Engagement & Business Partnership
- Partner with the business to understand and evaluate new stakeholder needs
- Apply GAMP and risk-based methodologies to determine validation scope and control requirements.
- Define and maintain automation strategies for high‑risk, high‑frequency, or high‑complexity system functions
- Collaborate with project teams and quality representatives across the organization
Documentation & SOPs
- Author and maintain Standard Operating Procedures (SOPs) related to CSV, data integrity, and IT compliance.
- Assist other departments with the generation, review, approval, and maintenance of quality documents
Leadership & Team Development
- Provide leadership and management within the department through structured objective setting and individual development planning
- Manage and deliver multiple projects of varying complexity
- Apply working knowledge of GxP regulations, reporting requirements, quality systems, Computer System Validation, and quality management tools
Education
- Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related discipline required (Advanced degree preferred)
Experience
- 8+ years of experience implementing, validating, maintaining, and integrating electronic document and Quality Management in an FDA or equivalent regulated settings
- Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc.
- Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC, Computer Software Assurance (CSA)
- Must have excellent communication skills (verbal and written)
- Demonstrate ability to manage projects and variable workloads
- Highly organized with a strong attention to details, clarity, accuracy, and conciseness