Associate Director - Quality Control

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.

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description:

Directs all group activities of up to 30 analytical QC staff which may include management levels. With safety First and Quality Always, advances operational excellence, continuous improvement and modernization. Plans work for the groups to respond to changing priorities. Maintains a safe, orderly and compliant work area according to company safety standards and cGMP regulations. Effectively represents the company with FDA and other Regulatory Agency officials related to QC expertise, as needed. BS is required and an advanced degree is desirable. Position requires at least 5 years of managerial experience.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

• Management and Leadership responsibilities such as:
• Direct all group activities of up to 30 QC staff which may include management levels.
• Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.
• Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s). Strategize against corporate objectives.
• Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
• Evaluate coach and manage personnel performance. Set group objectives with management.
• Participate in the budget process, including professional services. Monitor group spending to remain on track with budget.
• Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
• Build a strong, responsive team that is reliable, responsive and flexible to shifting demands.
• Focus on the situation and/or problem not the person. Maintain the self-esteem of staff.
• Technical responsibilities such as:
• Represent the department as a technical expert on the methods performed in the group and the results reported.
• Conduct thorough document reviews, including submissions to global health authorities.
• Respond effectively to any product or method-related trends.
• Use scientific expertise to assist direct reports with troubleshooting, investigations and problem resolution, including contract testing. Implement process improvements with senior leadership.
• Apply strategic-thinking and forward planning with high level of ownership/accountability.
• Compliance responsibilities such as:
• Assure adherence of acceptable cGMP practices by staff during execution of all work tasks.
• Review departmental documentation for conformance with global corporate policies and regulatory guidance.
• Represent the company through effective interactions with FDA officials, as needed, related to QC expertise.

Basic Requirements:

• BS is required.
• Advanced scientific degree is preferred.

Additional Preferences:

• Requires 5-7 (or equivalent) years of previous management experience with advanced degree.
• Proven competence with 10 years of related technical experience in protein product.
• Experience in monoclonal antibody is not required but a definite asset.
• Excellent working knowledge of cGMP regulations for QC laboratory applications is required.
• Excellent teamwork and communication skills.
• Attentive to detail.
• Good computer skills.
• Ability to take initiative, to be assertive, to lead by example and to build relationships.
• Strategic thinking capabilities.
• Forward planner.
• High level of ownership/accountability.
• Ability to effectively represent the company with FDA and other Regulatory Agency officials related to QC expertise.

Other Information:

• Travel not required.
• Lifting not required.
• Not required to be on call.
• Shift work may apply.

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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