Healthcare Job at Lilly | Senior Associate Global Patient Safety Role
This healthcare job opening at Lilly presents an opportunity to work within the Global Medicines Quality Organization in Bangalore. The Senior Associate/Principal – Global Patient Safety role focuses on quality systems, compliance, audits, and patient safety initiatives, making it suitable for professionals exploring Lilly careers India and jobs in Bangalore in the healthcare sector.
Healthcare Job Details:
- Job Title: Senior Associate/Principal – Global Patient Safety, Global Medicines Quality Organization
- Location: Bangalore, Karnataka, India
- Category: Manufacturing/Quality
- Job Type: Full Time Regular
- Job ID: R-96849
About the Company
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The company focuses on discovering and delivering life-changing medicines, improving disease management, and contributing to communities through philanthropy and volunteerism. Lilly careers India offers long-term healthcare job opportunities for professionals committed to quality, innovation, and patient safety.
Qualifications
- Bachelor’s Degree in a healthcare-related field or equivalent experience
- Experience applying quality systems in a regulated healthcare environment
- Strong project and time management skills
- Effective written and verbal communication skills
- Ability to manage multiple priorities
- Strong analytical, problem-solving, and critical-thinking abilities
- Interpersonal skills with flexibility across geographies
- Strong organizational and self-management skills
Healthcare Job Description
Lilly is hiring for this healthcare job, Senior Associate/Principal – Global Medicines Quality Organization (GMQO), to support the development and implementation of quality system strategies aligned with business goals. The role includes execution of quality system deliverables, compliance oversight, audit and inspection support, and collaboration with Quality and Global Patient Safety teams in India.
Key Responsibilities
Implement and Manage Quality Systems
- Contribute to the development of area-specific procedures, tools, and supplemental materials, including review and approval of quality system documents.
- Ensure regional and affiliate quality system requirements have clear accountability.
- Recommend updates or creation of quality system documents.
- Advise on training requirements for implementation and documentation.
- Provide consultation on regulatory requirements, standards, and procedures.
- Manage deviations, change controls, and Notification to Management (NTM).
- Support root cause analysis and corrective/preventive actions (CAPA).
- Provide input to risk assessments, audit planning, and quality plans.
- Conduct self-inspections and drive quality improvements.
- Ensure local implementation of quality systems.
- Support external and third-party quality management activities.
Quality Oversight – Global Patient Safety
- Monitor compliance with quality systems and identify gaps proactively.
- Escalate quality issues to management when required.
- Support implementation of regional and affiliate Quality Plans.
- Provide quality updates to business owners.
- Drive simplification and continuous improvement initiatives.
- Review metrics and trend data to enhance compliance.
- Compile and maintain compliance metrics.
- Analyze trends and recommend corrective actions.
- Monitor closure of deviations, CAPA, and audit responses.
Audits and Inspections
- Support audit and inspection readiness, coordination, and responses.
- Ensure availability of documentation such as training records and job descriptions.
- Track and ensure timely completion of audit corrective action plans.
- Collaborate with business partners on inspection readiness activities.
Partnership and IT Quality Support
- Act as the initial quality consultation point for Global Patient Safety.
- Partner with business teams to ensure appropriate quality controls.
- Share best practices and key learnings across quality networks.
- Collaborate with global quality groups.
- Support issue resolution and escalation.
- Apply a risk-based approach in guiding business areas.
- Support assigned quality and IT projects.
- Understand the role of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
- Serve as IT Business Quality Assurance (BQA) representative for assigned systems.
- Review and approve IT system documentation as MQO representative.
- Partner with IT teams on system-related initiatives and changes.
