Advisor - Quality Audit and Compliance (Controlled Substances)

Advisor - Quality Audit 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.

Responsibilities :

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.

Key Objectives / Deliverables :

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

Global SSS / CD Process Owner

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.

Auditing Responsibilities

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 assess level of compliance and / or readiness to meet established standards and current regulations and guidelines, as applicable.

Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable.

Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recuse oneself from an audit when a conflict of interest or lack of competency in a specific area exists.

Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non-verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner.

Exhibit skills relevant to auditing, such as evaluating and judging, drawing conclusions, understanding technical material and data integrity concepts, business understanding, identifying problem areas, knowledge of audit principles, and ability to manage time.

Business-related Responsibilities

Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.

Participate in the continuous improvement of the global quality system and other corporate priorities, as requested.

Establish and maintain relationships with the relevant business units, including providing audit-related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance.

Participate and / or support GQAAC self-assessments or regulatory inspections.

Personnel Development Responsibilities

Complete required training and qualifications as identified in your Learning Plan.

Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements.

Serve as a mentor and coach for others within the GQAAC organization.

Attending 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.

Basic Qualifications / Requirements :

Minimum of five (5) years' experience related to the pharmaceutical industry.

Bachelor's degree in Science or Engineering

Additional Skills / Preferences :

Ability to work safely to ensure self-safety and the safety of others.

Strong working knowledge of global regulations and guidelines (e.g., DEA, FDA, EU, and industry standards (e.g., ICH, ISPE, PIC / s) for CS and GMP operations) and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry.

Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).

Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.

Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.

Excellent personal skills, including motivation, self-management, commitment, and the ability to work well with others.

Excellent teamwork skills, including being open-minded and flexible to adopting new ideas.

Strong project management skills to manage projects at various stages and effectively multi-task.

Ability to maintain a flexible work schedule and adapt quickly to accommodate audit program priorities and other business-related priorities.

Working knowledge of Microsoft office 365 suite and other business programs (e.g., document management systems, quality management systems).

Additional Information :

Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50%, sometimes on short notice.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location.