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CT Materials and Centralized Services Director

2 months ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Main Purpose and Objectives of Position:

The PRD QA Senior Director - CT Materials Supply and Centralized Services will lead the team responsible for the oversight of quality-related matters and compliance across multiple areas (Clinical Trial Materials, Wholesalers, Ancillary Supplies, and Chemistry Manufacturing and Control QA) and geographies (global sites and external partners).

Scope:

The scope of this position includes CT Materials and Supply, Greenwood Innovation Center, Wholesalers, CMC QA and Complaints.

Key Responsibilities:
  • Responsible for the management oversight of the QA units supporting Clinical Trial Materials, Wholesalers, Ancillary Supplies, Chemistry Manufacturing and Control, and associated third parties.
  • Collaborate with PR&D and Global Quality Groups to qualify external collaboration partners, suppliers and/or partners to ensure compliance is met and maintained.
  • Lead improvement initiatives related to quality systems, implementation of new Quality Standards, and monitoring the effectiveness of the Quality System.
  • Ensure cGMP Compliance through establishment and utilization of appropriate quality systems and resources.
  • Maintain staffing with the right training, education, and experience to carry out the roles and responsibilities of the Quality Unit.
  • Ensure appropriate decisions are made when issues are escalated (e.g. complaints, deviations, potential retrievals, etc.).
  • Influence cross-functional manufacturing groups to maintain and improve the quality system.
  • Ensure that QA review and/or approval occurs for various cGMP documents including Quality Plans, Quality System documents, deviations, change controls, protocols, batch records, audit related documents, etc.
  • Foster an inclusive environment where continuous improvement and innovative ideas are implemented.
  • Ensure a self-inspection program is in place and participate in internal and external audits.
  • Manage relationships with multiple manufacturing partners across the globe.
Basic Requirements:
  • BS, MS or PhD in Pharmacy, Engineering, or Physical Sciences (or equivalent experience).
  • At least 10 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
  • Past leadership experience.
Other Requirements:
  • Demonstrated problem solving skills and a broad knowledge of quality system, and global quality standards.
  • An understanding of Regulatory agency requirements such as the FDA, EMEA, ICH, particularly in cGMPs.
  • Demonstrated solid judgment and initiative.
  • Previous experience working effectively with external partners.
  • Proficient in data visualization/analysis.
Additional Information:

This position requires occasional travel. The position flexibly supports activities in Indianapolis (LTCN).

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.

If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance.

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