New · posted Nov 13
Eli Lilly · Biotechnology
Quality Control Manager (External Operation)
- Boston, MA
- Hybrid
- Full-time
- Manager
The 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.
Verve is seeking a Manager, Quality Control External Operation, who will report to the Associate Director, External Quality Control and be responsible for assisting with the continued implementation, and management of Quality Control activities at contract manufacturers and contract testing laboratories for LNP and other drug product components for early development stages. We are looking for a candidate with strong technical and compliance experience to support a pipeline of gene-editing products.
What you need
Basic Requirements
- B.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field with 5+ years of relevant experience in the pharmaceutical or biotechnology industry
- MS degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field with 3+ years of relevant experience in the pharmaceutical or biotechnology industry
- 3+ years of demonstrated quality experience in a cGMP-regulated QC laboratory.
- Technical experience with QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, and cell-based potency assays.
- Experience authoring, reviewing and approving documents in Electronic Document Management Systems (Veeva).
- Knowledge and understanding of ICH guidelines, FDA/EMA regulations, and cGMP documentation practices.
- 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
- Ability to communicate across various cross-functional teams
- Experience with external vendor management (client or client facing function)
- Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, and problem solving.
- Self-motivation and leading the way for ensuring a fair and equitable work environment
- Thorough attention to detail, with the ability to critically analyze ideas, data, and reports.
- Strong oral and written communication and interpersonal skills
What you'll do
Verve’s Quality Control is seeking a candidate for the team to lead day-to-day Quality Control operations at external partners. This individual will be working with the Associate Director of Quality Control and will be supporting in-process, release, and stability testing by coordinating with external partners. The position will be part of the Technical Operations team that strives to advance preclinical gene editing candidates into the clinic and works closely with Quality Assurance, External Manufacturing, Process Development, and internal/external Quality Control.
- Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.
- Run day-to-day Quality Control Operations at external partners.
- Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.
- Lead the review and approval of Quality Control data and CoA/CoTs.
- Manage material specifications for excipients, drug substances and drug products.
- Handle the shipment of quality control samples from/to CDMOs and contract laboratories.
- Assist in coordination, oversight, and review of method validations at CDMOs and contract laboratories.
- Coordinate stability sample storage and testing per approved protocols.
- Other duties as assigned
Pay and benefits
$72,000 – $169,400 a year
Employer providedAdditional Information
- This is a hybrid position with a mandatory 3 days a week on-site at the Fenway location in Boston, MA.
- Travel Percentage: 10%
- Overtime and shift work may be required to support GMP production at external CDMOs.
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
$72,000 - $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.
Company bonus
401(k)
Pension
Medical, dental, vision and prescription drug benefits
Vacation and time off
Well-being benefits
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAJob intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in Massachusetts5 roles publishing pay
Manager roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $72,000 | — | $169,400 |
| Massachusetts (middle half) | $120,500 | $133,500 | $138,000 |
| All US (middle half) | $103,625 | $118,000 | $138,500 |
This role: Eli Lilly's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 265 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Lilly's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- GMP and compliance4
- Documentation and SOPs4
- Collaboration and leadership4
- Investigations and CAPA1
- Validation and qualification1
- Quality systems and risk1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Lilly on Regulatory Jobs
- 57
- Open roles
- 57
- Distinct roles
- 10
- Locations
By discipline
- Quality31 54%
- Clinical19 33%
- Regulatory7 12%
By level
- Director25 44%
- Senior & Principal16 28%
- Manager7 12%
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Quality Control Manager (External Operation) at Lilly
Open until filled. $72K–$169K a year, employer provided.