The Director of Quality will lead Quality Assurance and Compliance, implementing quality systems, collaborating across teams, and ensuring regulatory compliance in life sciences companies.
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-opportunity 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.
Top Skills
Cloud-Based Architectures
DevOps
Gxp
Iso 27001
Iso 42001
Iso 9001
SaaS
Security Frameworks
ValGenesis Chennai, Tamil Nadu, IND Office
C S I R Road, Taramani, 705-708, 7th Floor, Phase II, TICEL BIO Park Limited, , Chennai, Tamil Nadu, India, 600113
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