GMP Quality Assurance Specialist

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

GMP Quality Assurance Specialist

Position Summary:

The Quality Assurance Specialist plays a critical role in compliance with current Good Manufacturing Practices (cGMP) and internal quality standards. This position is primarily responsible for supporting the Quality Event Management (QEM) program, including the management of deviations and the Corrective and Preventive Action (CAPA) system as well as internal and external change controls.

Additional responsibilities may include assisting with the batch disposition process, quality metrics, document management, and other duties as assigned.

The ideal candidate will be a hands-on, detail-oriented professional who can effectively collaborate with cross-functional departments (e.g., external partners, Supply Chain, Regulatory Affairs) to ensure timely entry and closure of quality events.

This position reports into the Director, Quality Assurance – Compliance and Batch Disposition.

Main Responsibilities:

Quality Event Triage & Initiation:

• Serve as a primary point of contact for the intake and logging of quality events (deviations, change controls, OOS) into the electronic Quality Management System (eQMS).
• Assist in the initial classification and risk assessment of new events to ensure appropriate prioritization.

Investigation Support:

• Partner with cross-functional teams to facilitate timely investigations and follow-ups in the QMS
• Ensure all relevant documentation is archived in the QDMS in a timely manner.

CAPA Management:

• Track the lifecycle of CAPAs from initiation through closure, ensuring all tasks are completed by their due dates.
• Assist with CAPA effectiveness checks to verify that actions taken have resolved the initial issue and prevented recurrence.

Documentation & Compliance:

• Enter and/or assist others to enter all QEM documentation (investigation reports, CAPA plans, closure summaries) in a timely fashion.
• Assist in revising and updating SOPs related to the quality event management process.

Metrics & Trending:

• Assist in compiling, analyzing, and reporting on quality metrics and trends related to deviations and CAPAs for management review.

• Support preparations for internal audits and external regulatory inspections (e.g., FDA, EMA) by providing QEM documentation and records.

Qualifications:

• 3+ years relevant experience with BS in scientific discipline with at least two (2) years of experience in a pharmaceutical and/or biotech manufacturing environment.
• Candidate should ideally have experience working with external suppliers and quality event management.
• Must have strong interpersonal, negotiation, presentation, and communication skills.
• Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment.
• Ability to make rational, timely, and compliant risk-based decisions.
• Experience with Veeva Quality/Docs and Veeva QMS modules is highly desirable.

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $87,000- $107,000 per year.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.  

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. 

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [email protected]. 

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. 

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. 

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. 

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.  

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [email protected].