Associate Director, Development Quality – OSD

We need to produce HTML fragment with sections: About the role? The posting includes description about company, role responsibilities, qualifications, competencies, pay, benefits. We must not repeat job title as heading. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections with real specific content. We have: - About the role: Could be the introductory paragraph describing the role? The posting includes "Provides modality-focused development QA leadership for oral programs..." That's a description. So we can have About the role section with that paragraph. - Responsibilities: There's a "Key Responsibilities" heading with bullet points (Program QA Leadership (Oral) and Partner Oversight & Inspection Readiness). Those are responsibilities. - Requirements: There's "Required Qualifications" and "Preferred Qualifications". Could combine into Requirements? Usually Requirements includes required qualifications. Preferred could be separate but we can include under Requirements or Skills. The instruction: Use headings for sections like Requirements, Qualifications, Skills. We need to decide. We have both Required and Preferred qualifications. Could put Required under Requirements, Preferred under Qualifications? Or combine. The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can have separate sections for Requirements and Qualifications. We'll put Required Qualifications under Requirements, Preferred Qualifications under Qualifications. Skills: there is "Key Competencies" list. That could be Skills. - Benefits: there is description of benefits: flexible PTO, medical, dental, vision, life/disability, 401(k), voluntary benefits, mental health via EAP, etc. So Benefits section. - Pay: there is salary range: $168,737 - $198,073 per year. Also mention base salary determined by factors, equity, etc. So Pay section. - Schedule: Not mentioned. No schedule info. So we should not include Schedule section. We must not include boilerplate like EEO, scam warning, etc. Remove those. We must preserve all substantive information. Must not invent or summarize away detail. Must not include placeholder text like "commensurate with experience". We have none. We need to output only HTML fragment, no /, no markdown fences. We need to use

• for any list of duties/requirements/benefits, and

  for prose. Thus:

  About the role

  Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution.

  Responsibilities

  • Program QA Leadership (Oral)
    • Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones
    • Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure
    • Produce deliverables such as program quality plans, readiness trackers, and decision / action logs
  • Partner Oversight & Inspection Readiness
    • Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways
    • Maintain inspection-ready documentation, narratives, and evidence packages for program scope
    • Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes
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  • ? It's allowed but maybe better to keep flat list. However the content includes sub-bullets. Could keep as nested lists. It's still
    • . Acceptable.

      Requirements

      • BS+ Life Sciences / Engineering (or related)
      • 10–12 years QA experience with development-stage oversight
      • Demonstrated cross-functional leadership and risk-based judgment

      Qualifications

      • Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred)
      • Experience with external development networks and inspection support (preferred)

      Skills

      • Development QA governance, phase-appropriate oversight, and readiness milestone management for oral programs
      • Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement)
      • Partner governance and performance management across CMOs / vendors, inspection readiness evidence discipline
      • Cross-functional leadership, escalation, and executive-ready risk / decision communication
      • Quality risk management, issue triage, and timely action closure across development stakeholders
      • Veeva Vault Quality (eQMS) proficiency to track program quality events, vendor oversight, and readiness documentation

      Pay

      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 $168,737 - $198,073 per year. 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.

      Benefits

      • Flexible paid time off
      • Medical, dental, vision and life/disability insurance
      • 401(k) offerings (traditional, Roth, and employer match) in accordance with applicable plans
      • Additional voluntary benefits like supplemental life insurance, legal services, and other offerings
      • Mental health benefits through Employee Assistance Program for employees and their family
      • Other benefits in accordance with applicable federal, state, and local laws
      We should not include Schedule. Also we should not include any EEO or scam warning. Check that we didn't repeat job title. Good. We need to ensure we didn't include any placeholder like "commensurate with experience". Not present. We need to ensure we preserved all substantive info: The company description at start? The initial paragraph about Madrigal company and Rezdiffra etc. Should we include that? The instruction: "Preserve ALL substantive information". The initial description about Madrigal and Rezdiffra is substantive about the company, but not directly about the role. However it's part of the posting. Should we include it? Possibly under About the role or a separate section like "About the company". But the allowed headings list does not include "About the company". However we could incorporate that into About the role section as prose. The About the role currently only includes the role description. We could prepend the company overview to that paragraph. That would preserve info. Let's do that: In About the role section, include both company overview and role description. Thus:

      About the role

      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. Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution.

      That preserves company info. Now check for any other substantive info: The line "Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity." Already in Pay section. Also "All employees receive equity, which we believe reinforces our ownership culture." Already in Pay. Also "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." Slight duplicate but okay. We also have "By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization." Already. We also have "We comply with all applicable minimum wage laws." Could include in Pay section. Let's add a sentence. Add: "We comply with all applicable minimum wage laws." Also "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." Already captured. We also have "We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com." That's substantive but maybe considered boilerplate? It's about accommodations. Could be included but maybe it's considered EEO/legal? It's about accommodations, not EEO. Might be okay to include but the instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This is about accommodations, which is a legal requirement but not exactly EEO. Might be considered legal boilerplate. Safer to omit? The instruction says remove legal boilerplate. This is a legal statement about accommodations. I'd omit to be safe. Also "Madrigal is an Equal Opportunity Employer..." That's EEO, omit. Also "Unsolicited resumes from agencies..." etc. That's legal/scams, omit. Also "Applications are being accepted on an ongoing basis..." etc. That's application instructions, omit. Also fraud warning etc. Omit. Thus final HTML includes sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Pay, Benefits. Check that we didn't miss any substantive info like "We are building a dynamic, inclusive, and high-performing culture..." included in About the role. Check that we included "Our success is driven by our people..."