PHARMAFull time
Associate Director-Quality System Owner – Batch Release
By Admin · Quality Assurance & Quality Control
BENGALURU (IN)ONSITEPOSTED: 10/9/2026
PHARMAFull time
HIRING ORGANIZATIONGSKPharmaceuticals / Healthcare / Life Sciences
ROLE OVERVIEW
GSK is hiring an Associate Director – Quality System Owner (Batch Release) in Bengaluru to lead the development and deployment of AI and generative AI tools across GxP-regulated Quality processes. The role combines programme leadership with hands-on technical delivery, validation and lifecycle management of AI applications.
ROLE DEFINITION & RESPONSIBILITIES
- •Own and refine the roadmap and product backlog for the supported quality system and its AI applications.
- •Translate business-identified use cases into business requirements, cost and timing estimates and user requirements with process owners and Tech.
- •Drive AI prototypes through minimum viable product and further iterations to deliver efficiency or effort reduction.
- •Implement AI use cases across Quality domains with measurable impact on compliance, efficiency, adoption and user experience.
- •Act as business representative for technology aspects of AI-enabled Quality processes, ensuring compliant, harmonized GxP AI use across GSC.
- •Ensure AI applications comply with GxP and data integrity requirements, including Responsible AI, DTMS, computer software validation and AI risk and control measures.
- •Work with QMS and validation teams so AI tools are documented, validated and auditable, including preparing documentation for audits and inspections.
- •Monitor KPIs for AI adoption, accuracy and compliance, analyse trends, guide sites on error reduction and lead working groups for process improvement.
- •Train and onboard new users, interns and site Quality Experts on supported AI tools and processes.
- •Maintain a knowledge base of learnings and keep training materials accessible in centralized repositories.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 15+ years of professional experience with a Bachelor's or Master's degree, or equivalent experience.
- Degree in Engineering, Computer Science, Life Sciences or a related discipline.
- Demonstrated experience in digital transformation, AI/ML, scaled automation or technology solutions within life-sciences regulated industries.
- Proven leadership in deploying innovative solutions in highly regulated GxP environments.
- Strong experience in a technical or engineering role.
- Experience working in agile teams delivering enterprise-wide standardized solutions.
- Ability to work across an enterprise to influence business outcomes.
- Deep understanding of Digital, Data, Analytics, AI/ML and GenAI and their application in Quality systems.
- Strong knowledge of validation, compliance and risk management in pharmaceutical settings.
- Strong knowledge of business case creation and realizing value from digital project implementation.
- Excellent communication, stakeholder engagement and change management skills.
- Fluent in English.
PREFERRED QUALIFICATIONS
- •An additional language, such as French, is a plus.
REQUIRED VERIFIED SKILLS
Data Integrity
Digital Fluency
GxP Regulations
Influencing Without Authority
Lean Management
Problem Solving
Project Management
Quality Assurance (QA)
Quality Management Systems (QMS)
Risk Awareness
Technical Writing
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
GSK is a global biopharma company that develops and makes specialty medicines and vaccines. Its therapeutic focus areas include respiratory, immunology and inflammation, oncology, HIV, and infectious diseases.
TEAM SIZE: 70,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare / Life Sciences
APPLICATION ADVISORY
This posting asks for 15+ years of experience and proof of delivering AI/ML, automation or digital transformation in a GxP-regulated life-sciences setting, so lead with those projects and the validation, risk and data-integrity work behind them. Highlight hands-on technical or engineering delivery, agile team experience and business cases where you realized measurable value. Also show stakeholder engagement across Quality, Tech and regulatory functions, since the role interfaces with Responsible AI, Digital & Tech, Business, Regulatory and Data Governance.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.