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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

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.

Responsibilities:

During the project phase, the Associate Director- Parenteral Operations (AD), is responsible for staffing and onboarding team members supporting the delivery of the Parenteral new lines and departments. This AD is also responsible for QA oversight of qualification documents and SOPs needed for the area, as well as inspection and operational readiness to ensure the lines are in compliance with regulatory standards and expectations. This AD is part of a cross-functional Team, as a member of Flow Team (FT), and having reports that are part of the Process Team (PT).

Key Deliverables: 

Technical and administrative leadership, as well as project management. 
• Serve as technical resource to review and approve technical documents 
• Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework 
• Work with the Site Quality Leader to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the device and 
packaging programs 
• Support initial recruiting, build capability, for a diverse quality assurance staff to support qualification, validation and routine production 
• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team 
• Support the development of the overall site operational readiness plan including development 
of quality processes and approval of operational procedures and controls 
• Foster a strong quality culture including maintaining open communications and promoting 
teamwork and employee participation in the work group

• ​Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment 
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc. 
• Network with global and other parenteral sites to understand best practices and share 
knowledge 
• Participate in tactical and strategic business planning 
• Work cross-functionally with the area process teams for metrics reviews, operational support, 
and issue/deviation management 
• Set QA human resource and business plan goals 
• Define and execute inspection readiness activities 
• Interact with regulatory agencies during inspections regarding cGMP issues 
• Ensure data integrity by design

 

Basic Qualifications:

Bachelor's degree in a STEM or pharmaceutical related field of study.

 

Additional Skills/Preferences:

At least 7 years working in the pharmaceutical industry Previous management or leadership experience including leading or working effectively with a cross functional group.Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA.Excellence in; interpersonal, electronic, written, and oral communicationStrong technical aptitude and ability to train and mentor othersCommit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification • Strong knowledge of Quality Management Systems and applicable regulatory requirements 
• Previous experience directly supporting a pharmaceutical manufacturing operation 
• Excellent interpersonal, written and oral communication skills 
• Strong technical aptitude and ability to train and mentor others 
• Demonstrated technical writing skills 
• Demonstrated problem-solving and decision-making skills 
• Previous facility or area start up experience 
• Previous equipment qualification and process validation experience 
• Previous experience with Manufacturing Execution Systems and electronic batch release 
• Previous experience with deviation and change management systems including Trackwise

 

Additional Information:

Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

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