Sr. Principal Associate - QA - Global Quality Auditing and Compliance

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

$96,000 - $162,800
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 35,000 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 Global Supplier Auditor (Supplier Auditor) represents QA-Procurement, which is responsible for the Corporate Supplier Quality Auditing program supporting commercial and clinical manufacturing globally for Lilly human health drug products/devices.

Through auditing, the Supplier Auditor assures that the Supplier or GMP Service Provider has systems and processes in place that are aligned with established standards and are compliant with current regulations and guidelines. The position also assists in determining the appropriate quality oversight and ongoing evaluation needed for each supplier and GMP Service Provider. This position reports to a GQAAC QA-Procurement Associate Director.

The Supplier Auditor also provides support to the site/affiliates by supporting the management of material suppliers and GMP service providers, participating in self-assessment activities and supporting internal/external GQAAC audits/regulatory inspections of the Material/Supplier System.

GQAAC (QA - Procurement) is operating as a valued business partner with manufacturing and procurement and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Supplier Auditor plays a key part in contributing to the implementation of this strategic approach to supplier quality auditing and the SQM program for Lilly.

Key Objectives/Deliverables:

The following activities will be performed according to established procedures, guidelines, forms and tools. These responsibilities are not intended to be all-inclusive:

• Auditing:
  • Scheduling, preparing, conducting and reporting local and global supplier audits to assess the level of compliance with established standards and current regulations and guidelines. This includes leading complex audits ("for-cause", leading audit teams, etc.).
  • Follow-up with suppliers and GMP service providers to ensure corrective actions are taken to satisfactory close audit observations.
  • Appropriately escalate any compliance issues.
  • Meet the requirements defined in quality standards, quality manuals, policies, procedures, and tools.
  • Based on need and employee development, complete required actions to participate on commercial (Lilly Sites and Contract Manufactures) audits.

This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

• Global Quality - Business Related Responsibilities:
  • Contribute to the approval process of a new supplier or GMP service provider.
  • Provides support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, QualityDocs, TrackWise.
  • Participate or lead the preparation and/or review of documentation used to establish supplier quality requirements, when needed.
  • Participate in the preparation of organizational metrics and trending of audit findings, when required.
  • Participate in the evaluation of third-party auditing firms/programs.
  • Lead and/or participate in global teams (e.g., Global Auditors Forum).
  • Network with other GQAAC business partners on best practices.
  • Participate and/or support GQAAC internal inspections or external regulatory inspections.
  • Participate and/or lead site self-inspections activities, when needed.
  • Influence customers (internal & external) and partners when improvement needs are identified related to SQM.
  • Identify the need and drive the revision of GQAAC quality system documents when appropriate.

• Site/Affiliate Support:
  • Assist purchasing, manufacturing and support groups in identifying and managing material suppliers and GMP Service Providers.
  • Assist in the approval process of a new supplier or GMP service provider.
  • Participate or lead self-assessment activities associated with material management
  • Support site-based internal audits and regulatory agency inspections
  • Assist sites in determination of supplier risk
  • Support the local supplier change notification triage process by providing input and guidance
  • Provide input and support for supplier management deviations and change controls
  • Liaison for the sites with suppliers and GMP service providers.

• Personnel Development:
  • Support training to less experienced auditors.
  • Serve as a mentor and proactive coach for others within the organization. Be considered as a person of reference within the function for technical and auditing advice.
  • Maintain good interpersonal and communication skills with auditees and business areas with emphasis on verbal and technical writing skills.
  • Complete required training and qualifications for the roles identified in the Individual Learning Plan.
  • Be continually aware of current industry trends and regulatory agency interpretation of requirements.
  • Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
  • Actively participate in external activities that build influence in areas relevant to the business.
  • Provide technical OJT evaluation and review of the qualifications for all new auditors.
  • Provide technical input and recommendations into audit observations via Audit Review Board.

• Participate or lead divisional improvement efforts, including Six Sigma projects and departmental/site teams, as assigned.
• Participate in other audit types conducted by GQAAC as requested.
• Execution of this work requires limited supervision. This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations and industry practices / state of the art, deep and breadth technical knowledge in the area(s) of responsibility, and a senior auditor's approach of continuous self-development and fulfillment of training needs.

Basic Requirements:

• Bachelor's degree or higher in chemistry, microbiology, physical or biological sciences, engineering or other technical area.
• 5+ years of quality or manufacturing experience within the pharmaceutical environment.

Additional Preferences:

• Certification by an external group (e.g., ASQ).
• Experience working on a global team and sharing knowledge.
• Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
• Work independently as well as collaboratively within a global team environment.
• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
• Project Management Skills.
• Auditing experience
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
• Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization and to the suppliers.
• Good analytical/problem-solving skills. Pragmatic decision making.
• Proven ability to think and analyze from a process perspective. Project management skills.
• Establish and maintain effective working relationships at all levels internal and external to Lilly.
• Deliver constructive feedback to customers while providing a high level of customer service.
• Ability to influence and manage change/conflict.

Other Information:

• Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50%, sometimes on short notice.
• Position is located at Indianapolis Corporate Center OR another Lilly Site. This position is not fully remote and will need to be tied to a physical Lilly facility within the US.

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