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.
Main Purpose and Objectives: The Associate Director-Quality Assurance is responsible for leading, educating, facilitating, enforcing, and ensuring compliance with Good Manufacturing Practices (GMP) and Corporate Quality policies. This role serves as a liaison between flow teams and the Quality Management Department. The Associate Director is responsible for process support, quality systems owner and oversight, inspection management and acts as the responsible person for all current GMP matters in the absence of the Sr. Director Quality.

REQUIREMENTS:

• Knowledgeable on requirements of regulatory agencies (BLA and NDA)
• Experience in audit management and interactions with Regulatory entities such as FDA, EMEA, ANVISA, PMDA etc.
• Knowledgeable of all quality systems such as deviation, changes, batch disposition, laboratory practices, and material management.
• Experience in on compliance/ regulatory aspects associated to new molecule introduction (prefer) and pharmaceutical manufacturing process
• Experience with asset delivery, process and computer system validation, facilities and equipment qualification and computer system
• Experience as supervisor in a GMP facility

EDUCATIONAL REQUIREMENTS:

• BS in Chemistry, Biology. Microbiology, Pharmacy or Chemical Engineering

EXPERIENCE REQUIREMENTS:

• At least 10 years of experience in Quality Assurance

OTHER JOB REQUIREMENTS:

• Establish positive interpersonal relations and interact effectively with people.
• Work under minimum supervision.
• Work under time pressure and be flexible and agile when priorities change.
• Lead a diverse team and make decisions.
• Exercise good judgment in special situations.
• Anticipate implications and consequences of situations and take appropriate action.
• Use a logical, systematic approach to problem-solving.
• Identify information needed to clarify a situation and seek that information from appropriate sources.
• Focus on desired end results, set challenging objectives, and meet or exceed those objectives.
• Influence and teach others.

KNOWLEDGE:

• Technical expertise in pharmaceutical operations and related sciences.
• Managing multiple project objectives.
• Technical writing and current GMPs.
• Personal Computer (PC) literate.

LANGUAGE REQUIREMENTS:

• Fully bilingual (English and Spanish) with excellent written and verbal communication skills.
  Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
  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
  $108,000 - $158,400
  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.
  

  WeAreLill

• Ensure compliance with GMPs and quality corporate policies.
• Drive compliance decisions for the site initiatives and processes
• Assure inspection readiness for internal and external audits
• Interact with auditors internal and external during GMP inspections.
• Actively seek to expand knowledge of technology and applicable regulations through external trainings and reading.
• Implement operational systems that support the business strategies assuring compliance with applicable regulations.
• Responsible of the timely completion of deviations, changes, batch disposition activities manage by direct reports
• Provide oversight and guidance for the compliance aspects of the operation.
• Design, approve, and communicate departmental objectives and applicable metrics.
• Lead quality assurance professionals and ensure the development of personnel in accordance with job requirements.
• Participate in the preparation of the departmental budget, strategic planning and capital planning
• Lead and coach quality assurance front line including process, laboratory and compliance.