Associate Director - Qa Analytical R&D

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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Associate Director- Quality Assurance Analytical is to provide management oversight and technical leadership to the Quality Assurance (QA) Representatives within the Analytical QA Group at Product Research and Development (PR&D) to ensure quality and compliance requirements for the analytical laboratories. The individual will provide analytical oversight for testing of Clinical Supply material, consult with business partners (both internal and external laboratories) on quality-related matters, review metrics, and drive for continuous improvement.
Responsibilities:
• Quality Functions and Systems Oversight: Responsible for the management of the Analytical QA Representatives providing primary responsibilities: CT molecule QA support, Reference Standards operations, partner lab oversight, and audit support. Also, ensure the roles and responsibilities of the Quality Unit are carried out and provide daily support with respect to quality decisions that impact analytical testing and laboratory operations.
• Quality Leadership supports and advises business personnel supporting the functional areas within PR&D analytical groups and associated collaboration partners. Ensure appropriate and timely decisions and approvals are provided for items such as protocols, change controls, deviations, standards, and SOPs, along with escalating issues as appropriate.
• Administrative Responsibilities / Department Development: Responsible for the oversight of the Analytical QA representatives and associated collaboration partners. Accountable for the strategic and logistical resourcing of the Analytical QA Representatives, through planning, prioritization, and operational oversight. Establish sufficient and capable Analytical QA support through mentoring, coaching, and associated Performance Management needs in order to execute the roles and responsibilities for the Analytical QA Representative's supported functions.
• Compliance & Audit Readiness: Provide overall support and logistics for internal and external audits, as needed.
Basic Requirements:

• Bachelor's Degree or higher in Chemistry, Biology, Engineering, or related scientific field
• Minimum 5-7 years of QA/QC experience in a regulated environment

Additional Skills/Preferences:

• Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable.
• Previous demonstration of strong laboratory leadership skills
• Proficient with computer systems including Microsoft Office, Trackwise, SAP, etc.
• Analytical quality expertise and experience in GMP environment
• Demonstrated problem solving skills and a broad knowledge of analytical laboratories and quality systems.
• An understanding of the basic requirements of Regulatory agencies such as the FDA, EMEA, ICH, OSHA and EPA particularly in the area of cGMPs.
• Must exhibit good teamwork, communication and interpersonal skills.
• Ability to influence team interactions and lead initiatives
• Ability to work simultaneously with several subjects between interactions and distractions

Additional Information :
• Occasional travel may be required for collaboration partner oversight, training, conferences, etc..
• M-F, 8 hours hybrid on-site presence, onsite presence required the majority of the time
• Indianapolis, IN Lilly Technology Center - North (LTC-N)
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