Eli Lilly and Company · 2 weeks ago
Advisor – Quality Audit and Compliance (Controlled Substances)
Indianapolis, IN
Full-time
Hybrid
Mid, Senior Level
$116K/yr - $185K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on improving lives through innovative medicines. The Advisor – Quality Audit and Compliance role is responsible for ensuring compliance with regulations concerning Controlled Substances, providing guidance throughout the product lifecycle, and conducting audits to maintain quality assurance in pharmaceutical development.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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 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 recluse 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
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
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
Qualification
Required
Minimum of five (5) years' experience related to the pharmaceutical industry
Bachelor's degree in Science or Engineering
Preferred
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)
Benefits
Company bonus
401(k)
Pension
Vacation benefits
Medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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