Advisor – Quality Audit and Compliance (Controlled Substances)

Role Summary

Advisor – Quality Audit and Compliance (Controlled Substances) at Lilly. Responsible for regulatory interpretation and guidance across the product lifecycle for Special Security Substances and Controlled Substances, and for assuring quality through internal and external audits in support of pharmaceutical development and commercialization.

Responsibilities

• Global SSS/CD Process Owner: define Quality, SSS, and CS requirements; build relationships with regulatory authorities; manage DEA registrations and related reporting; interpret regulatory requirements; develop or support CAPAs; escalate compliance issues; ensure adherence to quality standards and procedures.
• Auditing Responsibilities: interpret Lilly standards and regulatory guidance; plan, conduct, and report audits, assessments, and due diligences of GMP Operations and SSS/CD; lead risk assessments and mock inspections; provide technical input on audit observations; maintain ethics, objectivity, confidentiality, and effective communication; apply audit principles and manage time.
• Business-related Responsibilities: contribute to continuous improvement of the GQAAC quality system and other priorities; maintain relationships with relevant business units; provide audit-related advice and inspection readiness assistance; support self-assessments or regulatory inspections.
• Personnel Development Responsibilities: complete required training; stay current on regulatory trends; mentor others; attend training/conferences to share knowledge.

Qualifications

• Minimum of five (5) years' experience related to the pharmaceutical industry.
• Bachelor's degree in Science or Engineering.

Skills

• Ability to work safely and interpret global regulations (DEA, FDA, EU, ICH, ISPE, PIC/s) for CS and GMP operations.
• Auditing experience with external certification (e.g., ASQ Quality Auditing) preferred.
• Strong project management, prioritization, and multitasking abilities.
• Effective oral and written communication; ability to interact with all levels of the organization.
• Collaborative and flexible mindset; strong interpersonal and teamwork skills.
• Proficiency with Microsoft Office 365 and quality management systems.

Education

• Bachelor's degree in Science or Engineering.

Additional Requirements

• Domestic and international travel required; up to 50% travel, sometimes on short notice.