Associate Director - Quality Control

Overview:

Quality Control Associate Director (QC AD) is responsible for leading the QC organization for the Microbiological Labs and the Environmental/Utilities Monitoring team at the Lilly Research Triangle Park (RTP) site. The QC AD provides laboratory leadership and has responsibility for lab operations delivery, staffing and development, training/procedures and method delivery as the lab starts up in phased conjunction with production. Additionally, the QC AD will continue to help build a strong quality culture and lead the QC team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

Responsibilities

• Demonstrated technical competency (method understanding) and leadership in a QC microbiology lab (e.g., sterility, bioburden, particulates, preservative effectiveness, microbial identification
• Demonstrated technical competency (method understanding) and leadership in Environmental Monitoring of both traditional aseptic environments and isolators (e.g., viable monitoring – active and passive, non-viable monitoring, personnel monitoring). Understanding of Annex I requirements. Climet and MODA experience is extremely beneficial
• Demonstrated technical competency (method understanding) and leadership in Utility Monitoring (e.g., Process Air, Water for Injection, Clean Steam)
• Experience with microbiology method transfer and compendial method verification
• Experience with microbiology equipment commissioning and qualification
• Experience with microbiology laboratory start-up operations
• Demonstrated project management skills
• Demonstrated administrative leadership of a diverse team including performance management and personnel development
• Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan
• Ability to manage a complex change agenda in a fast-paced environment
• Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates
• Ability to demonstrate flexibility with quick response as priorities change or issues arise
• Active communication on project status
• Partner with QC Associate Director for Chemistry and Device Lab to set cohesive QC organization and operation
• Partner with production and design operation to ensure 24/7 support for required testing and monitoring against production schedule
• Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc
• Ensure all aspects of safety are incorporated into the lab and maintain a safe work environment, including supporting all HSE Corporate and Site Goals
• Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation
• Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections

Basic Requirements

• Bachelor of Science in Microbiology/Biology or related science
• 7+ years GMP lab experience including use of aseptic technique, testing and method transfer
• Previous leadership experience including leading or working effectively with a cross functional group.

Additional Skills/Preferences:

• Deep understanding of compliance requirements and regulatory expectations
• Excellent written and oral communication skills
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems
• Strong technical aptitude and ability to train and mentor others
• Project management experience
• Demonstrated problem-solving and decision making capability
• Demonstrated technical writing skills
• Proven cross-functional leadership

Additional Information:

• Ability to work 8 hour days – Monday through Friday
• Ability to work overtime and off shift as required to support a 24/7 manufacturing facility
• The position is onsite for the Lilly Research Triangle Park campus and allows for the ability to periodically work remotely (up to 4 days per month) based on the project phase, site and operational activities
• Position may require periodic business travel (~10%) to establish specific QC knowledge and establish global contacts