About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation total compliance and manufacturing excellence intelligence across their product lifecycle Learn more about working for ValGenesis the de facto standard for paperless validation in Life Sciences https www valgenesis com about About the Role Responsibilities Develop and execute the organization s Quality operation plans aligned with business goals and regulatory expectations Lead the Quality Assurance QA Quality Control QC and Compliance functions across the global organization Build coach and mentor a high-performing quality team Quality Management System QMS Oversee the design implementation and continuous improvement of the Quality Management System compliant with industry standards e g GxP ISO 9001 ISO 42001 ISO 27001 Establish and maintain standards for documentation change control CAPA deviation management and process audits Software Product Quality Partner with engineering product cloud operations cybersecurity and regulatory teams to ensure quality across the SDLC Software Development Life Cycle Ensure compliance and robust practices for SaaS cloud-hosted and security-related product enhancements Drive quality gates risk assessment and release readiness for software products Regulatory Compliance Ensure organizational compliance with relevant Life Sciences regulations e g GAMP 5 FDA EMA guidelines 21 CFR Part 11 Monitor emerging regulations and trends to proactively adjust quality strategies Customer External Audits Lead and manage customer audits regulatory inspections and third-party assessments with confidence and professionalism Prepare teams for audit readiness and ensure timely remediation of findings Cross-Functional Collaboration Partner closely with senior leadership to embed quality into business processes and culture Collaborate across R D Product Engineering Security Cloud IT Operations and Customer Success teams to enhance product and service quality Metrics Reporting Establish and track Quality KPIs dashboard reporting and management review metrics Communicate quality performance risks and improvements to executive leadership Requirement 15-20 years of progressive experience in Quality Assurance Quality Systems or Compliance roles Strong background working in Life Sciences Pharma Biotech Medical Devices Diagnostics or related sectors Experience in the IT industry and software product development environments Deep familiarity with cloud-based architectures SaaS models DevOps and security frameworks Proven track record managing customer audits regulatory audits and external assessments Demonstrated ability to build scale and optimize Quality Management Systems Excellent communication leadership collaboration and stakeholder management skills Preferred Qualifications Prefer Engineering Graduate with experience with GxP-compliant systems and validation e g CSV GAMP 5 Knowledge of cybersecurity standards and cloud frameworks e g SOC 2 ISO 27001 NIST Background working with cross-functional product teams in agile environments Advanced degree in Life Sciences Engineering Quality Management or related field Certifications such as ASQ CQE CQA ISO Lead Auditor PMP ACP or equivalent We re on a Mission In 2005 we disrupted the life sciences industry by introducing the world s first digital validation lifecycle management system ValGenesis VLMS revolutionized compliance-based corporate validation activities and has remained the industry standard Today we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations The Team You ll Join Our customers success is our success We keep the customer experience centered in our decisions from product to marketing to sales to services to support Life sciences companies exist to improve humanity s quality of life and we honor that mission We work together We communicate openly support each other without reservation and never hesitate to wear multiple hats to get the job done We think big Innovation is the heart of ValGenesis That spirit drives product development as well as personal growth We never stop aiming upward We re in it to win it We re on a path to becoming the number one intelligent validation platform in the market and we won t settle for anything less than being a market leader How We Work Our Chennai Hyderabad and Bangalore offices are onsite 5 days per week We believe that in-person interaction and collaboration fosters creativity and a sense of community and is critical to our future success as a company ValGenesis is an equal-prospect employer that makes employment decisions on the basis of merit Our goal is to have the best-qualified people in every job All qualified applicants will receive consideration for employment without regard to race religion sex sexual orientation gender identity national origin disability or any other characteristics protected by local law We may use artificial intelligence AI tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses These tools assist our recruitment team but do not replace human judgment Final hiring decisions are ultimately made by humans If you would like more information about how your data is processed please contact us

📌 Director Quality (Tamil Nadu)
🏢 ValGenesis
📍 Tamil Nadu