Lilly
Healthcare
Sr.Director-Quality
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“Sr. Director - Quality at Lilly. Skills: Quality Management System, Regulatory requirements, Continuous improvement. Oversee Quality Management System execution. Ensure cGMP compliance”
What You'll Achieve.
Improve site goals; Meet planned timelines; Release batch records; Maintain compliance status
Industry & Context.
Root cause investigation; Deviation analysis; Complaint analysis; Stability failure analysis; Out of specification analysis
What They're Looking For.
Must Have
5+ years of experience, Experience with parenteral manufacturing, Experience with device assembly, Experience with packaging
Nice to Have
Master's degree preferred, Experience with quality control function, Experience with quality agreements
What You'll Do.
Oversee Quality Management System execution
Ensure cGMP compliance
Influence leadership on quality strategy
Establish site quality objectives
Lead quality improvement projects
Provide quality support for business objectives
Manage team agenda and budget
Provide leadership in product quality matters
Assure independence of quality unit
Make decisions regarding quality issues
Ensure products are fit for use
Comply with regulatory requirements
Lead regulatory agency inspections
Respond to regulatory inquiries
Review GMP documentation
Approve GMP documentation
Manage department productivity
Develop department staff
Enhance department staff
Provide quality oversight for manufacturing
Provide quality oversight for device assembly
Provide quality oversight for packaging
Provide other Quality support functions
Ensure staff training and understanding of ethics
Ensure a safe and healthy work environment
Drive improvement towards site goals
Ensure staff qualification
Carry out initial training
Carry out continuous training
Carry out GMP education
Develop people capability
Develop people knowledge
Communicate quality objectives
Communicate quality priorities
Manage resources according to quality objectives
Manage resources according to site priorities
Anticipate future business needs
Ensure quality activities meet timelines
Provide administrative support
Provide technical leadership
Assure independence of Site Quality Unit
Ensure development of quality management system
Ensure adequacy of quality management system
Ensure effectiveness of quality management system
Ensure systems release raw materials
Ensure systems release intermediates
Ensure systems release packaging materials
Ensure systems release device components
Ensure systems release consumables
Establish system for evaluating batch records
Establish system for releasing batch records
Ensure necessary controls are carried out
Ensure testing is carried out
Ensure monitoring is carried out
Approve specifications
Approve sampling instructions
Approve batch records
Ensure quality agreements are in place
Ensure quality agreements are maintained
Ensure site processes are qualified
Ensure site equipment is qualified
Ensure site instruments are qualified
Ensure site utilities are qualified
Ensure site facilities are qualified
Ensure site processes are validated
Ensure site equipment is validated
Ensure site instruments are validated
Ensure site utilities are validated
Ensure site facilities are validated
Perform root cause investigation
Monitor corrective actions
Evaluate proposed changes
Ensure CAPA program is in place
Ensure quality plan is in place
Develop Local Quality Plan
Approve Local Quality Plan
Develop Site Quality Manual
Approve Site Quality Manual
Ensure governance and control process
Monitor quality indicators
Discuss actions to improve QMS
Conduct Management Review of Quality Systems
Ensure notification process is effective
Ensure escalation process is effective
Approve Annual Product Reviews
Ensure site audit readiness
Ensure inspection readiness
Assure timely closure of commitments
Assure adequacy of site quality systems
Assure effectiveness of site quality systems
Participate on Site Lead Team
Lead Quality Lead Team
Ensure overall compliance with GMP
Ensure overall compliance with Corporate Quality standards
Ensure overall compliance with regulatory requirements
Ensure process to maintain compliance status
Perform gap assessment
Ensure adequate quality oversight on GMP documents
Ensure adequate quality oversight on GMP activities
How You'll Work.
Team & Collaboration
Site Lead Team; Quality Lead Team; Quality Control partnership
Communication Scope
Regulatory agency communication
Process & Methodology
Roadmap implementation, CAPA program, Quality plan development
Full Job Description
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. The Site Quality Leader is primarily responsible for overseeing the execution of the Quality Management System. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. He/she effectively influences the leadership on strategic direction and tactical implementation of the quality system. The individual in this role establishes the site’s quality objectives, priorities, and roadmap. He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This may include new facility delivery or existing facility expansion/recapitalization. He/she will also provide quality support for achieving key business objectives. The Senior Director, QA, determines and manages the work agenda and budget for the team. He/she provides leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with US and international regulatory requirements. The Senior Director, QA, leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, training, master production records, technical protocols and reports, cha
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