Director – Validation
Noida, India

General Purpose:

  • Lead and own product testing & validation team to build high quality enterprise class software products for Pharmacovigilance industry.
  • Define and drive the product testing & validation strategies, plans and activities for various product releases as per RxLogix product development agile SDLC.
  • Essential Duties & Responsibilities Lead product testing and validation team to deliver high quality product features and releases.
  • Ensure timely and quality release of various product releases as per RxLogix Agile SDLC with appropriate oversight, monitoring and intervention.
  • Define, drive, and monitor product testing and validation activities for efficient, quality and timely delivery.
  • Lead, mentor & guide the testing team members for all type of testing activities and artefacts including (but not limited to) system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, etc.
  • Liaise with other department heads from Development, Product Management, Project Management, Quality, etc, to plan, monitor, deliver quality and timely product releases.
  • Accountable for high quality testing and release of all product features and product testing
    documents / artefacts.
  • Define and manage validation processes and tools for quality releases for the product.
  • Manage product and validation team resource load charts and their future allocations across multiple projects and products.
  • Collaborate with other department heads and company leadership on continuous process improvement (process, tools, skills, etc.), promote consistent company culture, growth, and meeting company’s vision & objectives.
  • Build and run a metrics driven organization.
  • Mentor his/her team by providing career development goals, semi-annual reviews, and advocating for their career advancement.
  • Predict, maintain, procure approval, and execute on resource hiring requirements for his/her team for upcoming and future needs based on product roadmap and new features.
  • Build or hire leaders & owners within his/her team to handle multiple projects and products.
  • Support company growth by building and maintaining a strong professional network as well as contributing to the recruitment of new employees.
  • Plan and manage the setup, costing, resourcing, and maintenance of all product environments need by his/her team and responsibilities.
  • Monitor and ensure customer satisfaction for quality of his/her product(s).
  • Represent his/her department to clients, company leadership, inspections, and audit (external and internal) and drives RCA, action plans and CAPAs to closure.

Minimum Requirements

  • Bachelor’s or Master’s degree in Computer Science, Management or related field from a top college in India or abroad (e.g. Top 20 colleges in India).
  • Overall, 15-20 years of total experience with minimum of 5-10 years of experience of managing high performing testing and validation teams of 15-20 or more people.
  • Pharmacovigilance domain knowledge and experience of working with top pharma companies and pharmacovigilance products like Argus, ArisG is highly preferred.
  • Knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GxP and CSV guidelines that are applicable to life sciences industry is highly preferred.
  • Strong team management and delivery management capabilities.
  • Efficient in handling multiple products and teams with competing priorities.
  • Strong experience with Agile methodologies with enterprise-level application development projects for SaaS and cloud-based applications.
  • Solid understanding and experience of Agile tool such as JIRA, Confluence and all Microsoft Office Tools.
    Proven ability to lead software product quality teams and ensure objectives, goals, and commitments are met.
  • Strong focus on quality delivery and SDLC compliance.
  • Self-motivated, leadership capabilities, strong organizational skills, action and results oriented.
  • Demonstrated ability to meet commitments, build consensus, negotiate resolutions, and garner respect from other teams.
  • Well organized and clear thinker.
  • Excellent communication and client/audit handling skills.
  • Willingness to travel for 1-2 weeks short business trips occasionally within the country and to other countries if needed to meet clients and internal stakeholders.

Travel Expectations