Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance
Position Summary
We are seeking an experienced Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Quality) to lead and mature our global PV Quality function during an exciting phase of global commercial growth.
Key Responsibilities
Pharmacovigilance Quality Oversight
Provide strategic and operational Quality oversight of global post-marketing pharmacovigilance systems, ensuring compliance with FDA, EMA, MHRA, ICH, and other global health authority requirements.
Maintain and expand a robust global Quality PV framework to ensure processes align with GVP, ICH, and other quality system requirements across all markets.
Serve as the primary Quality partner to Safety for governance of safety processes, including case management, signal management, aggregate reporting, and risk management activities.
Lead Quality risk management for PV, including identification, mitigation, and escalation of compliance risks impacting patient safety.
Develop and execute the global PV audit strategy and risk-based audit program covering internal processes, affiliates, vendors, and partners.
Support rapid response to emerging product quality concerns and ensure actions are implemented effectively.
Own and govern the global Product Quality Complaint process, ensuring compliant intake, investigation, documentation, trending, and closure.
Oversee PQC processes across internal teams and external partners, ensuring alignment with GMP, GDP, and PV requirements.
Lead complaint system KPI and metrics to identify systemic issues and drive continuous improvement.
Maintain a validated global Product Quality Complaint system in compliance with GXP requirements.
Oversee complaints trending and analysis to identify signals or emerging risks impacting product quality or patient safety.
Quality Systems, Governance & Compliance
Establish, maintain, and continuously improve PV-related quality systems, SOPs, and work instructions appropriate for a mid-sized, global organization.
Oversee deviations, investigations, CAPAs, change controls, and effectiveness checks related to PV and PQC activities.
Ensure inspection readiness through proactive gap assessments, internal audits, and compliance monitoring.
Develop and track meaningful quality metrics to support management review and decision-making.
Provide Quality input to safety agreements and vendor Quality oversight for global service providers.
Vendor & Partner Oversight
Provide Quality Oversight of PV and complaint-related vendors, service providers, and partners.
Lead qualification, auditing, and ongoing performance monitoring of external PV vendors.
Review and approve quality agreements and ensure clear delineation of roles and responsibilities for PV service providers.
Leadership & Strategy
Lead and mentor a global team of PV QA professionals.
Function as a key Quality liaison to Safety, Manufacturing, Supply Chain, Regulatory Affairs, Medical Affairs, and Commercial teams.
Provide guidance and training to internal stakeholders on PV and complaint-related quality requirements.
Contribute to governance forums and leadership discussions impacting product quality, patient safety, and compliance.
Drive strategic quality initiatives to strengthen compliance culture and inspection readiness.
Partner with senior leadership to shape the Quality vision and support global commercial growth.
Preferred Qualifications
- Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline.
- Advanced degree preferred.
- 12+ years in pharmaceutical or biopharmaceutical industry, including significant experience in post-marketing PV QA and at least 5 years in QA (GVP and GMP).
- Demonstrated leadership in global PV QA programs and complaint systems.
- Proven experience leading and supporting regulatory inspections (FDA, EMA, MHRA, etc.) and implementing CAPAs.
- Strong understanding of ICH, GVP Modules, FDA 21 CFR, EU PV requirements, and EU Vol4.
Quality Systems, Governance & Compliance
- Establish, maintain, and continuously improve PV-related quality systems, SOPs, and work instructions appropriate for a mid-sized, global organization.
- Oversee deviations, investigations, CAPAs, change controls, and effectiveness checks related to PV and PQC activities.
- Ensure inspection readiness through proactive gap assessments, internal audits, and compliance monitoring.
- Develop and track meaningful quality metrics to support management review and decision-making.
- Provide Quality input to safety agreements and vendor Quality oversight for global service providers.
Leadership & Strategy
- Lead and mentor a global team of PV QA professionals.
- Function as a key Quality liaison to Safety, Manufacturing, Supply Chain, Regulatory Affairs, Medical Affairs, and Commercial teams.
- Provide guidance and training to internal stakeholders on PV and complaint-related quality requirements.
- Contribute to governance forums and leadership discussions impacting product quality, patient safety, and compliance.
- Drive strategic quality initiatives to strengthen compliance culture and inspection readiness.
- Partner with senior leadership to shape the Quality vision and support global commercial growth.
Company Information
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 $244,000 - $299,000 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 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 provide any personal information.