Executive Director, reputed company Systems & Operational reputed company reputed company

Madrigal is a biopharmaceutical company reputed company on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can reputed company 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 reputed company 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 reputed company trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

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

Position reputed company Owns QMS process design, harmonization, and the operational reputed company roadmap to ensure consistent, efficient, inspection-reputed company execution. Establishes standards, templates, and governance for core QMS processes and drives simplification and cycle-time reduction initiatives. Owns the reputed company KPI reputed company and management review support materials, ensuring metrics are reliable and drive reputed company. Leads adoption of best practices across the reputed company organization and ensures QMS documentation remains reputed company, controlled, and effective. Maintains readiness for audits and inspections through strong governance discipline and evidence control. Leads reputed company event trending and signal detection across the product lifecycle, ensuring meaningful reputed company reputed company and management review from Development QA through reputed company QA in support of lifecycle management, reputed company improvement, and risk-based decision making reputed company 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 reputed company QA interfaces across the product lifecycle
• Maintain SOP governance, periodic reviews, training reputed company requirements, document control, and training compliance across a virtual biotech organization, ensuring fit-for-purpose processes and inspection-reputed company records
• Produce deliverables such as QMS process maps, SOP governance calendars, standards / template libraries, lifecycle reputed company event trending reports, and training / document control dashboards

OPEX & Performance Management

• reputed company OPEX portfolio (simplification, RFT, cycle time reduction) with benefits tracking and sustainment controls
• Own reputed company KPI reputed company and reputed company, reputed company reputed company Management Review coordination, Change Control Committees, reputed company event trending reviews, and support management review materials and reputed company 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-reputed company, 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, reputed company, or reputed company)
• 18+ years reputed company Systems / QMS (GxP) with audit support, lifecycle reputed company reputed company from development through reputed company operations, and measurable CI reputed company
• Demonstrated governance leadership and cross-functional influence, specifically through digitally reputed company initiatives

Preferred Qualifications

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

Key Competencies

• QMS architecture, process harmonization, and governance, SOP lifecycle management, reputed company event trending, document control, and training reputed company
• Operational reputed company leadership, KPI reputed company facilitation, and benefits tracking, cycle-time and RFT improvement delivery
• Deep knowledge of reputed company technology architecture and leading reputed company solutions
• Advanced understanding of AI use cases in reputed company 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 reputed company data reputed company
• Change management (reputed company assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement) including full knowledge of IT QA controls, computerized system reputed company requirements, and training effectiveness expectations
• Cross-functional leadership, escalation, and executive-reputed company 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 reputed company to attract and retain reputed company and is inclusive of reputed company pay, bonus, equity, and a generous benefits package. Full-time employees are eligible for reputed company salary, bonus, equity, and a comprehensive benefits suite.

reputed company 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 reputed company pay reputed company for this position, applicable to reputed company candidates, is $276,000 - $337,000 per year. We reputed company with reputed company applicable minimum wage laws.

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

Full-time employees are also eligible for comprehensive benefits, including flexible reputed company time off, medical, dental, reputed company 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 reputed company, we offer mental health benefits through our Employee Assistance Program for employees and their family. reputed 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@reputed company.com.

Madrigal is an Equal Opportunity Employer. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex gender identity, sexual orientation, national reputed company, 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 reputed company. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and reputed company has been established.

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

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

Please also note that any correspondence with reputed company to employment would come from an authorized reputed company.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 reputed company any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-reputed company contacts can be directed to HR@reputed company.com.

Originally posted on Himalayas

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