Sr. Principal Associate for Analytical Quality Assurance - Foundry

Regulatory Jobs; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Pension

Vacation benefits

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance in Indiana. The role ensures lab activities at the Lilly Medicine Foundry adhere to global and site quality standards and cGMP, maintaining data integrity and regulatory compliance.

The position supports design and construction phases, providing quality oversight for GMP testing, analytical development, and qualification of methods and instrumentation, while establishing and maintaining a robust quality management system.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• Minimum 5 years of technical laboratory experience in QA.
• Strong knowledge of analytical method development and validation.
• Familiarity with current GMP expectations and quality management systems.
• Experience with large-scale capital project deliveries is desirable.
• Authorized to work in the United States full-time.

Responsibilities

• Provide quality oversight for analytical testing, including qualification of labs and quality documentation.
• Oversee method verification, qualification, and validation activities.
• Lead quality improvement initiatives and implement new quality standards.
• Investigate deviations, stability failures, and out-of-spec results.
• Review and approve GMP documentation with technical experts.
• Collaborate with Lilly quality organizations to implement quality systems.
• Promote a positive quality culture across laboratory areas.
• Identify and lead cross-functional process improvement projects.

Skills

Quality Assurance

cGMP knowledge

Analytical testing

Audit support

Quality systems

Documentation review

Communication skills

Leadership

Process improvement

Problem solving

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Tools

Analytical instruments

Laboratory QA systems

Job description

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.

Overview:

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.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Sr. Principal Associate for Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners are carried out in accordance with global and site quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation, reporting, and maintenance of analytical data.

As the Foundry is currently in design and construction, this position will provide Quality oversight for the detailed design and quality processes related to GMP testing and analytical development as well as qualification support for analytical methods and instrumentation. The position is responsible for ensuring that the quality management system is established and adhered to for this area.

Responsibilities

• Provide quality oversight in Analytical testing, namely: molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records).

• Provide quality oversight of method verification, qualification, and validation activities.

• Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.

• When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data.

• Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.

• Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.

• Be available for consultation on quality-related issues as needed.

• Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices.

• Promote a positive quality culture and oversee quality presence in the respective laboratory areas.

• Identify and lead process improvement projects impacting multiple business areas.

Basic Requirements:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience. Quality assurance experience in the pharmaceutical industry, preferred.

• Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.

• Strong knowledge of analytical method development and validation.

• Strong knowledge of the current GMP expectations and application of quality management systems in execution.

• Minimum 5 yrs of experience in laboratories and analytical testing.

• 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.

Additional Preferences:

• Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.

• Ability to provide input and influence decision making for complex technical issues.

• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

• Experience with networking across industry, such as with industry groups or committees.

• Success in coaching and mentorship.

• Ability to establish key relationships and influence peers and business partners.

• Strong communication skills.

• Ability to identify and prioritize issues, develop, and implement solutions.

• High learning agility and ability to deal with ambiguity and uncertainty. Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis

Other Information:

• Initial location at Parkwood West, Carmel, Indiana.

• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

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.

#WeAreLilly

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

$65,250 - $169,400

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