Associate Director, Global API Quality Business Process

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $162,800

Position Summary:

The Associate Director Global Quality Business Process for Multi-Site API Quality Standardization will lead efforts to define, document, and deploy standardized QA and QC processes across all new API manufacturing sites, ensuring alignment with central QMS and operational requirements. This role is critical in developing scalable and streamlined quality practices/processes to support the establishment and operational efficiency of new API sites globally. By integrating LEAN principles and ensuring alignment with global regulatory expectations, the individual will play a key role in driving standardization efforts that enable consistent quality compliance and operational excellence across the network. 

This role is responsible for helping to coordinate and build these efforts globally.   They will develop and deploy the standardized business processes which are integrated with the electronic tools, this includes integrated delivery schedules and implementation tools. 

Key Responsibilities: 

1. Standardization of Quality Systems:

- Conduct a thorough analysis of existing QC/QA processes and procedures across sites to determine which need to be standardized based on impact, regulatory requirements, and operational efficiency. 

- Create a comprehensive timeline and roadmap to identifying critical quality processes that need immediate attention and others that can be addressed later. Establish clear milestones and timelines for each phase of standardization.

   - Develop, document, and deploy standardize quality procedures tailored for new site start-ups and existing site alignment.  

2. Process Integration for New API Site: 

   - Collaborate on integrated schedules and priorities for new site deployment, starting with key locations (e.g., Lebanon and Limerick).  

- Accelerate implementation of standardized practices/processes, ensuring readiness for regulatory inspections and operational functionality.  

3. Cross-Functional Collaboration:

   - Work closely with manufacturing site leaders, QA and QC SMEs, and other global teams to ensure harmonized implementation of processes and systems.  

- Ensure that each site is aligned with global QMS standards and that the system is properly implemented across the network.

- Partner with Operational Excellence teams to incorporate LEAN principles into quality processes.  

4. Communication and Change Management:

   - Develop robust communication strategies to ensure alignment across sites and stakeholders.  

   - Identify implementation barriers, propose solutions, and manage risks throughout the process.  

Basic Requirements

- Bachelor’s degree (or equivalent) in a scientific or engineering discipline.  

- Minimum of 8 years of experience in GMP manufacturing quality, technical services, or engineering. 

- Demonstrated experience in leading QA and QC documentation management.  

- Comprehensive knowledge of cGMPs, regulatory requirements, and quality systems.  

- Proven ability to manage complex, cross-functional projects in a global environment.  

- Strong communication skills with the ability to influence at all levels.  

Preferred Qualifications:

- Familiarity with IT systems supporting quality operations.  

- Experience in global or multi-site roles with cross-functional assignments.  

- Strategic project leadership experience, particularly in new site start-up environments.  

Other Information:

- The position may require global travel to support workshops. 

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