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.
We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance & Quality to lead our enterprise-wide compliance initiatives related to DSCSA. This role will be responsible for ensuring the integrity, traceability, and regulatory compliance of our pharmaceutical supply chain, while also driving continuous improvement in quality systems and operational excellence.
The Sr. Director - DSCSA Compliance & Manufacturing Logistics Quality Assurance, is a Quality professional with expertise in GMP quality assurance and DSCSA compliance. The Sr. Director ensures that DSCSA serialization requirements are met for commercial products sold in the US market.
Key Responsibilities
Strategic Leadership: Define and execute the company's DSCSA compliance roadmap, aligning with FDA requirements and corporate quality objectives.
Enterprise Compliance Oversight: Lead cross-functional teams in implementing and maintaining serialization, verification, and traceability systems across all supply chain nodes.
Quality Systems Integration: Ensure DSCSA compliance is embedded within the broader Quality Management System (QMS), including CAPA, change control, and audit readiness.
Regulatory Intelligence & Risk Management: Monitor evolving DSCSA regulations and FDA guidance; assess compliance risks and develop mitigation strategies.
Stakeholder Engagement: Serve as the primary point of contact for regulatory bodies, trading partners, and internal leadership on DSCSA-related matters.
Audit & Inspection Leadership: Lead DSCSA-related inspections and audits; ensure documentation, processes, and systems are inspection-ready at all times.
Technology & Data Governance: Oversee implementation and validation of serialization and EPCIS data exchange platforms (e.g., TraceLink, SAP ATTP).
Security Engagement: Serve as the Quality point of contact for security topics related to distribution, storage and transportation of commercial products (e.g., authentication technologies, serialization-related topics).
Basic Qualifications
Education: Bachelor's degree in Pharmacy, Life Sciences, Engineering, or related field; advanced degree (masters, doctorate) preferred.
Experience: 10+ years in pharmaceutical quality, regulatory, or compliance roles.
Technical Expertise: Deep knowledge of DSCSA, FDA regulations, and global serialization standards (e.g., GS1, EPCIS).
Leadership Skills: Executive presence with strong communication, negotiation, and decision-making skills. Ability to influence at all levels of the organization and with external partners. Proven effectiveness in collaborating with cross-functional teams and in hosting regulatory inspections.
Additional Skills / Preferences
Strong candidates for this role will have many or all the following:
Strong analytical and problem-solving skills to identify and address issues and optimize system performance.
Experience with Serialization Data Broker Solutions such as Tracelink.
Experience with warehouse systems and processes.
Project management experience and/or proven effectiveness in driving process improvement (certifications such as PMP or Six Sigma may be advantageous).
Understanding of Global Serialization data exchange requirements including DSCSA.
Familiarity with serialization protocols, unique identifier generation and aggregation methods
Knowledge of product labeling, track-and-trace methodologies, and regulatory compliance related to global serialization.
Prior involvement in industry working groups or DSCSA pilot programs.
Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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