Executive Director, Quality Systems & Operational Excellence Lead

Madrigal Pharmaceuticals; Pennsylvania Furnace (PA); On-site; USD 276,000 - 337,000; Full time

Benefits offered by this job

Equity

Bonus eligible

Comprehensive benefits package

Flexible PTO

Job summary

Madrigal Pharmaceuticals is seeking a Quality Systems leader to design, harmonize, and drive the QMS across the product lifecycle from development to commercial. The role focuses on establishing standards, templates, governance, and a reliable KPI framework to enable inspection-ready operations.

You will own governance for SOPs, training impact, and document control while coordinating with Development QA through Commercial QA.

Qualifications

• BS+ in Life Sciences, Engineering, Quality, or related.
• 18+ years Quality Systems / QMS with audit support and lifecycle oversight.
• Governance leadership across cross-functional teams.

Responsibilities

• Own QMS architecture, standards, and templates; drive harmonization.
• Lead OPEX programs, KPI cadence, and management reviews.
• Ensure inspection readiness with audit evidence and remediation tracking.

Skills

Quality Systems

QMS

Audit support

Governance leadership

Digital initiatives

Education

BS+ in Life Sciences, Engineering, Quality, or related

Tools

Veeva Vault QMS

Quality Docs

Deviation workflows

CAPA

Job description

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.

Position Summary

Owns QMS process design, harmonization, and the operational excellence roadmap to ensure consistent, efficient, inspection‑ready execution. Establishes standards, templates, and governance for core QMS processes and drives simplification and cycle‑time reduction initiatives. Owns the Quality KPI framework and management review support materials, ensuring metrics are reliable and drive action. Leads adoption of best practices across the Quality organization and ensures QMS documentation remains current, controlled, and effective. Maintains readiness for audits and inspections through strong governance discipline and evidence control. Leads quality event trending and signal detection across the product lifecycle, ensuring meaningful insight generation and management review from Development QA through Commercial QA in support of lifecycle management, continuous improvement, and risk‑based decision making within a virtual biotech operating model.

Key Responsibilities

QMS Design, Standards & Governance

• Own QMS architecture, process ownership model, and standards / templates, drive harmonization across teams / partners as applicable, including Development QA, IT QA, and Commercial QA interfaces across the product lifecycle
• Maintain SOP governance, periodic reviews, training impact requirements, document control, and training compliance across a virtual biotech organization, ensuring fit‑for‑purpose processes and inspection‑ready records
• Produce deliverables such as QMS process maps, SOP governance calendars, standards / template libraries, lifecycle quality event trending reports, and training / document control dashboards

OPEX & Performance Management

• Lead OPEX portfolio (simplification, RFT, cycle time reduction) with benefits tracking and sustainment controls
• Own Quality KPI framework and cadence, Lead Quality Management Review coordination, Change Control Committees, quality event trending reviews, and support management review materials and action tracking
• Produce deliverables such as OPEX roadmap, benefits tracker, KPI pack, and management review decks

Inspection Readiness

• Ensure QMS documentation and evidence are audit / inspection‑ready, drive remediation plans for gaps
• Maintain process narratives and consistency of execution across the organization
• Produce deliverables such as inspection readiness checklists, evidence indexes, and remediation trackers

Required Qualifications

• BS+ (Life Sciences, Engineering, Quality, or related)
• 18+ years Quality Systems / QMS (GxP) with audit support, lifecycle quality oversight from development through commercial operations, and measurable CI outcomes
• Demonstrated governance leadership and cross‑functional influence, specifically through digitally focused initiatives

Preferred Qualifications

• Experience in pharmaceutical / biotech Quality Systems, global standards deployment, lifecycle management across Development QA to Commercial QA, and operating effectively within a virtual biotech environment (preferred)
• Proficient with Veeva Vault Quality / QMS, Quality Docs, and related quality system workflows including deviations, CAPA, change control, training, and document management

Key Competencies

• QMS architecture, process harmonization, and governance, SOP lifecycle management, quality event trending, document control, and training oversight
• Operational excellence leadership, KPI cadence facilitation, and benefits tracking, cycle‑time and RFT improvement delivery
• Deep knowledge of Quality technology architecture and leading Quality solutions
• Advanced understanding of AI use cases in Quality and an ability to drive from strategizing to implementing these use cases and the key foundational prerequisites
• Understanding of data management leading practices to drive a consistent and connected Quality data foundation
• Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement) including full knowledge of IT QA controls, computerized system quality requirements, and training effectiveness expectations
• Cross‑functional leadership, escalation, and executive‑ready risk / decision communication
• Inspection readiness discipline, audit narrative readiness, evidence retrieval / traceability, and the ability to operate effectively in a virtual biotech organization

Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package. Full‑time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.

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 $276,000 - $337,000 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 [e-mail].

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 of incorrect/fraudulent email addresses, with Madrigal misspelled, that 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: 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 [e-mail].