Software Product Compliance Manager - BioTech/SaaS/Cambridge, MA

Job Description POSITION SUMMARY: Alkermes is seeking a Sr. Systems Analyst, within the R&D IT team. This person would work closely with our Development, Clinical, Regulatory and Medical, DSPV organizations to evaluate, implement, enhance and support current systems and solutions. They will assist in optimizing data capture, data aggregation, and data analysis. The preferred candidate will utilize their experience to implement key functionality within these groups to help facilitate the develo

Job Summary: We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will support validation, compliance, qualification, and operational activities for critical laboratory systems while ensuring adherence to FDA regulations, GxP guidelines, and data integrity standards. The candidate should possess hands-on experience

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Job Title Software Design Assurance Eng Job Description The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.Lead in the effective applicati