Capa Engineer Jobs in Exton, PA (NOW HIRING)

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- 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.

Owns deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high-quality manner. Establishes standards for investigation rigor, root cause analysis, impact assessment, and linkage to CAPA and change control. Drives performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply. Maintains inspection readiness through consistent documentation practices and governance routines across internal and external partners as applicable. Coaches teams on investigation quality expectations and effective prevention actions.

Key Responsibilities

Process Ownership & Governance

• Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation)
• Ensure consistent severity classification and impact assessment expectations across teams / sites / partners
• Produce deliverables such as deviation governance playbooks, triage guides, and KPI dashboards

Investigation Quality & CAPA Linkage

• Drive RCA rigor and evidence standards, coach investigators and ensure high-quality conclusions and documentation
• Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented and verified
• Produce deliverables such as investigation quality checklists, CAPA linkage reports, and effectiveness review summaries

Trending & Inspection Readiness

• Own deviation trending and management review inputs, identify systemic themes and drive cross-functional actions
• Maintain inspection-ready deviation records and process narratives, support audits / inspections and responses
• Produce deliverables such as trend reports, management review packs, and inspection-ready narratives

Required Qualifications

• BS+ in Science / Engineering (or related)
• 7-10 years in GMP QA / QMS with strong deviation / investigation leadership experience
• Demonstrated improvements in cycle time, investigation quality, and recurrence reduction

Preferred Qualifications

• Experience in pharmaceutical / biotech external manufacturing networks and partner deviation governance (preferred)
• Experience with eQMS workflows and continuous improvement / problem-solving facilitation

Key Competencies

• Deviation governance, investigation quality standards, and cycle-time / backlog management, escalation, and action closure discipline
• RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
• Partner governance and performance management across sites / CMOs for deviation quality and responsiveness (as applicable)
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness
• Veeva Vault Quality (eQMS) proficiency to drive deviation workflow execution, CAPA linkage, and trending

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. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $147,600 - $180,400 per year. We comply with all applicable minimum wage laws.

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 HR@madrigalpharma.com.

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 HR@madrigalpharma.com.