Associate, Internal Quality Control Operations

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.

Job Summary

The Sr. Manager, Internal Quality Control Operations will report to the Director of Quality Control and will be located on site (4 days a week) at 201 Brookline Ave Boston, Ma. The role will support cGMP analytical testing of various gene therapy products.

As a Quality Control Sr Manager, you will be responsible for overseeing and maintaining the integrity of our products and processes. In this role, you will assist a team of quality control specialists to ensure that all products meet both internal standards and industry regulations. You will collaborate closely with production, QA, and supplier teams to ensure prompt release of testing data to support clinical material, investigate non-conformances, and drive corrective actions. You will perform analytical testing, lead investigations, qualifications and validations of methods, and review data generated in the lab.

Job Responsibilities

• Perform analytical testing of release and stability products in the QC laboratory.
• Train QC analysts on analytical methods, investigation writing, certificate of analyses creation and review, method qualification and various high level QC processes.
• Create and lead a certified trainer process wining QC.
• Lead review of laboratory logbooks.
• Develop, implement, and maintain robust quality control procedures, specifications, and testing methodologies for various products.
• Ensure all QC activities align with cGMP, FDA regulations, ICH guidelines, and other applicable global regulatory standards.
• Lead investigations into out-of-specification (OOS) and out-of-trend (OOT) results, identifying root causes and implementing effective corrective and preventive actions (CAPAs).
• Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and R&D teams to optimize processes and resolve quality-related issues.
• Prepare and review QC documentation, including protocols, reports, and standard operating procedures (SOPs).
• Engage in internal and external audits, providing expert support and responding to audit observations.
• Drive continuous improvement initiatives within the QC operations to enhance efficiency, accuracy, and compliance.
• Mentor, train, and develop a high-performing team of QC professionals.

Basic Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related scientific field
• Minimum of 10 years of experience in Quality Control or a CMC environment within the pharmaceutical or biotechnology industry, with at least 2 years in a leadership or management role
• 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 Skills/Preferences

• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 210/211), ICH guidelines, and other relevant global quality standards.
• Proven experience with analytical techniques such as NGS, ELISA, Cell-based potency, PCR, and cell culture.
• Demonstrated ability to lead and motivate a team, with strong interpersonal and communication skills.
• Excellent problem-solving, analytical, and decision-making abilities.
• Experience with LIMS (Laboratory Information Management System) and other quality management software.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

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

$71,250 - $161,700

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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