Associate Director - Plant Quality Assurance

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

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.

Responsibilities:

The Director is responsible for managing the activities of Quality Assurance personnel supporting Indy Parenteral Operations, with respect to regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness within those areas.

• Develop, lead, and support the site Safety, Quality, Compliance and Team Lilly initiatives and culture.
• Mentor, coach and provide feedback to employees
• Manage or assist with the department budget, participate in organizational planning, development of business plan for area of responsibility
• Lead and influence strategic initiatives for operational excellence
• Exhibit cross-functional influence
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities
• Participate actively on the plant flow team, plant quality lead team, and other governance instances at the plant 
• Ensure adequate quality oversight for manufacturing operations within their plant and areas of responsibility
• Exhibit critical business decision making taking into consideration quality, compliance and business aspects, escalate critical quality issues
• Review/Approve GMP documents (examples include but not limited to deviations, procedures, protocols, change controls, complaints)
• Ensure Plant inspection readiness
• Actively participate in self-led and/or agency inspections

Basic Requirements:

• PharmD, or BSc/MSc in scientific or technical degree: chemistry, biology, microbiology, pharmacy, engineering or equivalent scientific / technical degree, or equivalent experience
• 15+ years of experience in Pharma, 5+ years in leadership roles
• Experience at level and prior cross-functional experience.
• Strong Influencing Skills and interpersonal and teamwork skills. Excellent communication skills
• Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment
• Demonstrated relevant experience in a regulated manufacturing environment
• Proficiency with computer systems including Microsoft Office products
• Demonstrate strong oral and written communication and interpersonal skills
• Experience with being a mentor, coach and / or giving and receiving feedback

Additional Preferences:

• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Experience in Production, QC, QA, Technical Services, Engineering and/or Regulatory is desirable.
• Previous experience with deviation and change control process
• Previous experience leading and influencing strategic planning and operational excellence initiatives
• Experience in pharmaceutical industry

Additional Information:

• Overtime may be required
• May be required to respond to operational issues outside of core business hours and days
• Applicant will work in various areas within the Parenteral Operations so mobility requirements should be considered. Some allergens are present in the Parenteral Plant so exposure to allergens should be considered when applying for this position.

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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