Sr. Associate- Quality Assurance

Eli Lilly

Puerto Rico, Carolina Onsite Quality (Jfg)

About this role

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Patients are at the center of everything we do at Lilly. We are currently hiring a Principal Associate- Quality Assurance.

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly

Job Overview:

Serve as educator and facilitator to ensure compliance with Good Manufacturing Practices and Corporate Quality policies of PR01 plant.

Serve as liaison between the flow of PR01 and Quality Management Department. Leads and coordinates the Quality Systems metrics ensuring compliance with regulatory and corporate requirements.

Responsibilities:

Quality System: Ensure compliance with Good Manufacturing Practices (GMPs) and quality corporate policies, including participating in/leading Quality Systems initiatives, supporting audits and regulatory inspections, and monitoring the Self Inspection Program.
Compliance: Ensure the site complies with laws and regulations from the Puerto Rico Department of Health and other regulatory agencies (FDA, EMA, OSHA, EPA, DEA), and interact with regulatory agencies during GMP inspections.
Management of Controlled Substances (if applicable): Comply with requirements to receive and maintain authorization to handle controlled substances, including background checks, required training, and reporting of drug diversion or illicit activities.
Internal Regulatory Fulfillment: Complete required compliance training, comply with safety and industrial hygiene requirements, and observe environmental standards and practices.
Network: Interact internally across all departments and levels, and externally with affiliates, regulatory agencies, and Site Network/ Global interactions.
Regent Pharmacist duties: Be registered with the Department of Health, ensure compliance with applicable laws and regulations, oversee manufacturing processes, ensure registered shifts are covered, and manage plant license renewal and documentation. Owns/ Lead inspection readiness program. Owns/ Lead/ Instruct/ Educate Deviation Management System and Change Control System.

Requirements:

Bachelor-Degree in science, MS or PhD in Pharmaceutics (desired).
Minimum of 10 years of experience in Quality Assurance, manufacturing, technical services, quality and/or compliance areas.
Fully Bilingual (Spanish & English).
Teamwork oriented, good interpersonal and customer service skills.
Candidate must have a strong compliance mindset and sound judgment.
Ability to manage multiple priorities and work under minimum supervision.
The capacity to achieve results and influence through people is critical.
Must exhibit a good sense of judgment in decision making, without the need for management approval while at the same time keeping management informed and engaged on critical issues.
Ability to influence personnel and organizations without having direct administrative responsibility for them.
Technical writing and presentation skills
Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment.
Knowledge of cGMP, applicable global regulatory manufacturing guidance, and the process/cleaning validation in drug substance pharmaceutical manufacturing.
Flexibility is required to support site needs in a 24/7 environment.
Ability to communicate and effectively influence across functional groups and stakeholders.
Technical leadership, administrative and organization skills
Strong problem-solving skills
Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.
Strategic thinking and ability to balance short term needs with long term business goals.

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.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$64,500 - $123,200

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