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Associate Director - Site Quality & Compliance QA for QC

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Apr 19, 2024

Job Details

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.

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 39,000 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. #WeAreLilly

The Site Quality & Compliance Organization assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Manufacturing’s central quality processes.

The Associate Director for Site Quality & Compliance is responsible for leading the activities of Quality personnel supporting central quality processes which may include a combination of quality oversight for laboratories, stability, materials, data stewardship, complaints, regulatory interactions, inspection readiness, and quality system ownership.

This specific position focus is QA for QC.

Responsibilities:

Team and Personnel Development:

  • Responsible for maintaining a safe work environment, leading safety initiatives, and working safely, and accountable for supporting all HSE Corporate and Site Goals
  • Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities.
  • Provide Feedback and Coaching to employees
  • Develop individuals and team to ensure continuous professional development
  • Develop, lead, and support the site Safety, Quality, and Compliance initiatives and culture
  • Scope of team may comprise of exempt and non-exempt employees.

Leadership:

  • Support the site business plan and influence agenda to ensure reliable supply of quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readiness
  • Actively assist in governance instances across the site based on assigned areas of focus
  • Serve as a conduit for site, network, and corporate communications
  • Interact and engage with other areas in the site
  • Benchmark and network with other Lilly sites and Global Quality for communications and shared learning (best practices, takeaways, etc.).

Quality and Compliance oversight:

  • Exhibit critical business decision taking into consideration quality, compliance, and business aspects, raise critical quality issues, when appropriate, in a timely manner and proposing decisions into the escalation forums
  • Support Site Quality Plan and lead continuous improvement compliance initiatives
  • Ensure inspection readiness across the site focusing on areas of responsibility
  • Assist and lead others in support of regulatory inspections
  • Provide guidance to significant investigations and compliance gaps across the site
  • Approve (or reject) technical and quality documents that per local procedures requiring quality M2 level approval such as moderate deviations, changes, complaints, etc.
  • Ensure adequate quality oversight within their areas of responsibility
  • Act as primary back-up for other Associate Directors in Site Quality and Compliance, upon delegation of authority, the Sr. Director - Site Quality & Compliance.

Basic Qualifications:

  • Bachelors Degree required. Prefer degree in scientific or technical field: chemistry, biology, microbiology, pharmacy, engineering, or equivalent scientific / technical degree.
  • 10+ years' experience preferred
  • Strong influencing, 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 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, or Regulatory
  • Experience in pharmaceutical industry
  • Demonstrated successful leadership experience
  • Previous experience performing with Lilly Quality Systems (deviations, analytical investigations, change, and / or complaints).

Other Information:

  • Overtime may be required
  • May be required to respond to site compliance and business needs outside of core business hours and days
  • Applicant will be exposed to various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position
  • Some OUS and US travel may be required.

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.

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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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