Sr. Associate – QA Distribution

Description

• Make quality culture the foundation of your work, to ensure our products are delivered on time and in safe and effective manner to improve patients’ lives.
• Collaborate with site compliance leader and site data leader to ensure robust Quality System and Computer System Validation to ensure compliance and meet data integrity requirements.
• Understand NALO Operations to be able to provide quality oversight, identify and escalate potential Quality concerns, support meeting business goals and lead process improvement initiatives.
• Provide Quality oversight for NALO distribution operations network and maintain a state of inspection readiness for all distribution warehouses under NALO control. Support development of quality indicators/metrics to track Quality performance at all distribution locations.
• Collaborate both internally and externally to identify opportunities to standardize operations, increase global harmonization, and identify improvement opportunities.
• Apply Quality Risk Management principles to NALO operations, using Lilly quality standards. Author and review and approve Risk Assessments to ensure adequate oversight including external monitoring of regulatory changes.
• Provide quality oversight and maintain the qualified status of distribution supplier and service provider per Supplier Quality Management System.
• Manage, investigate and document product and distribution complaint and monitor performance.
• Author, review and approve quality documents such as deviation investigations, change control activities, CARTS, PPE, SCN’s, SOP …etc, with focus on issue resolution and continuous improvement.
• Develop and collect metrics related to the Quality performance within area of responsibilities. Provide updates to management and propose performance improvement.

• Support inspection readiness initiative and internal/external audits (site self-inspections; regulatory agencies and GQAAC).
• Support the Operations by
• Timely and accurately completing all assigned task and responsibilities
• Collaborate with other functions, including hands-on work experience and shared learning
• Propose solution and Benchmarking with other Lilly sites to gain support

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or Supply Chain/Logistics, or similar area
• 3+ years of QA/Distribution experience in the pharmaceutical industry.
• Prior QA experience working with Distribution, Medical Devices and providing oversite to 3Pls and SP.
• Knowledge and experience with CSQA and Quality Risk Management.
• Effective communication both written and oral
• Experience with ICH Q9 and/or Lilly’s Quality Risk Management standards
• Clear understanding of all GMP/GDPs, policies, procedures, regulations and guidelines related to commercial distribution.
• Knowledge and experience in quality records (Deviation, CC, PPE, SCN’s, procedure…etc).
• Demonstrated ability to be self-driven, work independently, and apply time management and project management skills
• High-quality skills to include ability to prioritize, critical decision making, interpersonal/people, problem solving
• Strategic thinking and ability to influence diverse groups and communicate effectively to all levels of an organization internally and externally
• Strive to exceed individuals and business goals and continuous improvement.