Director- Validation Job in Rxlogix Corporation

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
0-25%