Advisor – Quality Audit and Compliance; Controlled Substances

Advisor – Quality Audit and Compliance (Controlled Substances)

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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 Advisor – Quality Audit and Compliance is part of the Global Quality Auditing and Compliance (GQAAC) division, which serves as the corporate quality auditing interface for global GxP compliance. This role focuses on Lilly‑designated Special Security Substances (SSS) and Controlled Substances (CS), ensuring processes meet company requirements, regulations, and guidelines. The Advisor provides regulatory interpretation and guidance across the product lifecycle—from discovery and development through launch, commercialization, and licensing—for all SSS and CS materials, including API, drug product, finished product, samples, and reference standards.

Responsibilities include reviewing proposed CS regulations (particularly US DEA), collaborating with legal and industry groups on comments, owning and maintaining Lilly Quality Standard 303, and handling the risk assessment process for SSS designation.

The Advisor – Quality Audit and Compliance (Controlled Substances) also assures quality assurance through the execution of internal and external audits in support of pharmaceutical development and commercialization for Lilly. Through auditing, the GQAAC auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards.

GQAAC operates as a valued business partner by taking a proactive approach to further improving the quality status of business operations and regulatory compliance. The quality auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.

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

• Lead or participate in the preparation and review of standards, policies, procedures, and guidelines that define Quality, SSS, and CS requirements.
• Build and maintain relationships with regulatory authorities; facilitate and host inspections from the US DEA, Indiana Board of Pharmacy, and other state CS agencies as required.
• Maintain Power of Attorney documentation to manage DEA registrations, sign DEA Form 222, and complete required online reporting via the DEA website.
• Interpret regulatory and quality standard requirements for business processes and provide guidance in response to related inquiries.
• Develop or support corrective and preventive actions (CAPAs) to address gaps in SSS/CS compliance processes.
• Escalate compliance issues promptly and appropriately.
• Ensure adherence to applicable quality standards, manuals, policies, procedures, and tools.

• Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities.
• Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP Operations and SSS/CD to assess the level of compliance with established standards and current regulations and guidelines.
• Lead or participate in risk assessments and mock regulatory inspections of GMP Operations and SSS/CD to…