Sr. Principal Associate - GQA Advisor

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.

The Sr. Principal Associate – GQA Advisor is part of the Global Quality Auditing (GQA) team and represents a corporate quality-compliance interface supporting global GXPs. The position assures that the processes and procedures are in accordance with company requirements, current regulations, and guidelines.

The Sr. Principal Associate - GQA Advisor will perform internal investigations, which may be for-cause or human resources quality related in support of the HRQ program as well as perform GXP audits. This roles supports the process for escalation, investigation, and reconciliation and trending of compliance related investigations with potential impact to Quality coming from the HR function, and will assist in the assessment and investigation of Quality related deviations and applicable audits.

GQA is operating as a valued business partner to Manufacturing, Research & Development, Human Resources, Legal, and others in taking a proactive approach to further enhance the quality status of business operations and regulatory compliance.

Key Objectives/Deliverables:

1. Business/Technical Leadership/Compliance

• Manages sensitive information in accordance with Lilly Policies.
• Supports and participates in triage discussions to assess potential impact to quality and investigates accordingly and collaborates with cross functional partners to ensure procedural escalation and documentation requirements are met.
• Provides investigation guidance, can conduct root cause analysis to ensure consistency to sites for quality-related investigations associated with human relations or in cases of potential conflict of interest in the Quality unit (e.g., allegations against the Quality unit or Quality Leader).
• Conducts audits, root cause and trend investigations for GQA per established processes.
• Collaborates with the Quality Culture, Data Integrity, and GMP Training teams to identify/develop/deliver initiatives to address common themes across the programs.

2. Consulting/Mentoring

• Consults with cross functional partners to ensure investigations with potential human relations Quality impact are escalated per program requirements and drive consistent execution of GQS104.
• Consults with members of GQA for broader quality and compliance gaps and deviations and trending.

3. Personal Development and Shared Learning

• Attend training courses, conferences, or association meetings to continue to gain knowledge.
• Share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices.
• Be continually aware of current industry trends and regulatory agency interpretation of GxP and other relevant requirements.
• Continue to gain knowledge necessary to provide a greater understanding of GxP requirements.

4. Divisional/Global Quality Organization Support

• Participate in projects that support or enhance GxP Compliance and continuous improvement.

Minimum Requirements:

• Minimum Bachelor’s Degree in Pharmacy, Chemistry, Biology, Engineering Microbiology or other technical areas of study; minimum of 10 years relevant industry experience in areas that must include: Quality Assurance or Quality Control.
• Experience in Quality Assurance or GxP function with strong compliance knowledge with demonstrated ability to influence others, negotiate, and investigate .
• Experience and demonstrated ability to perform GXP audits for various modalities; including but not limited to paraenteral, .
• Deomonstrated critical thinking, root cause analysis, and complex investigation management experience.
• Demonstrated ability to communicate and deliver constructive feedback, including excellent oral and written communication and oral presentation skills.
• Demonstrated ability to interpret and apply standards to different situations by understanding subject needs and applying good problem-solving skills.
• Ability to work independently and as part of a team with minimal supervision

Education Requirements:

• BA, BS, MS or Ph.D. in a technical field, such as Biology, Chemistry, Engineering, Pharmacy or Microbiology

Other Information:

• Must be able to work in a GxP environment.
• Must be able to travel <10-50% including international travel.
• Position is located at Indianapolis Corporate Center or another Lilly US site.

Note: When applying internally for a position your current supervisor receives notification that you have

applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to

applying.

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.

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not

anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment

positions on the B or S paths or at levels M1-M2 or P1-P4.

#WeAreLilly

Lilly is proud to offer market-competitive employee benefits designed to empower you to live your best

life. Employees may elect medical, prescription drug, dental and/or vision coverage for you and your

family in one of two health plan options, enjoy best-in-class mental health support, and concierge services

for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation. We also support well-being

with a fitness membership, health coaching, and wellness activities at no additional cost. Our retirement

benefits are designed to help our employees feel secure in their financial future by including a defined

benefit pension, a 401(k) match, and retiree medical coverage. We provide life and disability insurance for

peace of mind and protection for you and your loved ones and paid time-off benefits to support you in life’s

moments that matter including personal illness, caregiver, bereavement, and other family needs, in

addition to annual paid vacation and holidays. Lilly reserves the right to terminate or modify company-

provided benefits at any time in its discretion. The company compensation structures are aligned to the

location of hire. The United States pay range and benefits offering do not apply to any location outside of

the United States.

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

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.

#WeAreLilly