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.
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.
Serves as Deputy Fachtechnisch Verantwortliche Person (FvP) to support ongoing compliance with Swissmedic requirements and applicable EU GMP/GDP expectations under the Swiss Pharmaceutical Establishment License (PEL). Acts as the designated operational backup to the FvP to ensure continuity of quality system execution, inspection readiness, and day-to-day quality oversight of GMP/GDP activities, while also providing oversight of API manufacturing quality activities across the global supply network. The role plays a critical part in ensuring continuity of API supply through oversight of contract manufacturers, onboarding of new API suppliers, management of quality and compliance risks, and support of manufacturing network expansion. Partners cross-functionally with Supply Chain, Chemistry, Manufacturing, and Controls (CMC), Regulatory Affairs, Clinical Operations, and external manufacturing partners to enable compliant, reliable, and uninterrupted product supply. Concurrently support global quality oversight and governance for API manufacturing, with particular emphasis on uninterrupted US API supply, leveraging internal and external resources for execution.
Key Responsibilities
Support the implementation and maintenance of the Swiss Quality Management System in alignment with Swissmedic, EU GMP/GDP, and global standards
Ensure the maintenance of the Swiss QMS in alignment with Swissmedic, EU GMP/GDP, and global standards, ensuring activities are executed in compliance with the PEL
Contribute to preparation, maintenance, and inspection readiness of the Swiss Pharmaceutical Establishment License (PEL), including controlled documentation and evidence availability
Support Swissmedic interactions (inspections, correspondence) as delegated, including timely coordination of requests and response drafting
Produce deliverables such as PEL support documentation packs, QMS evidence indexes, and inspection correspondence trackers
Swiss Quality System, PEL & Swissmedic Interface
Support batch certification / release activities as delegated by the FvP (where legally permitted)
Review manufacturing, testing, and distribution documentation for GMP/GDP compliance globally for API Supply and Ex US finish goods and identify gaps requiring correction or escalation
Monitor GDP-compliant distribution operations (3PL oversight, warehousing/transport conditions, temperature monitoring and excursion management)
Support issue management and escalation across internal and external stakeholders
API Manufacturing Oversight & Supplier Onboarding
Ensure quality activities associated with onboarding and qualification of new API manufacturing partners.
Ensure quality oversight of external API manufacturers and key suppliers across the global network.
Support technical transfers, validation activities, manufacturing readiness, and launch preparedness.
Drive quality risk management activities related to API manufacturing and supply continuity.
Monitor supplier performance, inspection outcomes, deviations, CAPAs, and change controls.
Support supplier governance processes and long-term manufacturing network strategy.
Partner with CMC and Supply Chain to ensure continuity of global API supply.
Inspection Readiness, Audits, CAPA & Delegated Coverage
Support regulatory inspections and internal/external audits.
Drive CAPA implementation, effectiveness checks, and inspection readiness activities.
Act as FvP delegate during approved absences within the scope authorized by Swissmedic.
Ensure critical quality and supply risks are appropriately escalated.
Collaborate with Regulatory Affairs, Supply Chain, CMC, Clinical, CMOs, distributors, and service providers to provide operational quality input to supply and regulatory decisions.
Required & Desired Qualifications
BS+ in Pharmacy, Chemistry, Biology (or related)
10-12 years pharmaceutical Quality Assurance experience with Swiss/EU GMP/GDP exposure and quality system execution experience
Demonstrated experience overseeing API manufacturing operations, CMOs/CDMOs, and supplier quality management.
Eligible to act as Deputy FvP per Swissmedic requirements (FvP recognition preferred), with demonstrated inspection readiness support, documentation rigor, and cross-functional coordination, fluent in German and English
Strong knowledge of EU GMP, Swissmedic requirements, supplier quality management, and quality risk management.
Experience overseeing GDP distribution partners (e.g., 3PLs), including temperature monitoring and excursion management and partner governance routines
Key Competencies
Strong operational execution in regulated environments
Solid understanding of Swiss/EU pharmaceutical regulations
Attention to detail and documentation rigor
Effective cross-functional collaboration
Ability to operate under delegated authority with clear judgment and escalation discipline
Veeva Vault Quality (eQMS) proficiency to manage QMS workflows, document and inspection-ready evidence retrieval (as applicable)
We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.
Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.
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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.
Serves as Deputy Fachtechnisch Verantwortliche Person (FvP) to support ongoing compliance with Swissmedic requirements and applicable EU GMP/GDP expectations under the Swiss Pharmaceutical Establishment License (PEL). Acts as the designated operational backup to the FvP to ensure continuity of quality system execution, inspection readiness, and day-to-day quality oversight of GMP/GDP activities, while also providing oversight of API manufacturing quality activities across the global supply network. The role plays a critical part in ensuring continuity of API supply through oversight of contract manufacturers, onboarding of new API suppliers, management of quality and compliance risks, and support of manufacturing network expansion. Partners cross-functionally with Supply Chain, Chemistry, Manufacturing, and Controls (CMC), Regulatory Affairs, Clinical Operations, and external manufacturing partners to enable compliant, reliable, and uninterrupted product supply. Concurrently support global quality oversight and governance for API manufacturing, with particular emphasis on uninterrupted US API supply, leveraging internal and external resources for execution.
Key Responsibilities
Support the implementation and maintenance of the Swiss Quality Management System in alignment with Swissmedic, EU GMP/GDP, and global standards
Ensure the maintenance of the Swiss QMS in alignment with Swissmedic, EU GMP/GDP, and global standards, ensuring activities are executed in compliance with the PEL
Contribute to preparation, maintenance, and inspection readiness of the Swiss Pharmaceutical Establishment License (PEL), including controlled documentation and evidence availability
Support Swissmedic interactions (inspections, correspondence) as delegated, including timely coordination of requests and response drafting
Produce deliverables such as PEL support documentation packs, QMS evidence indexes, and inspection correspondence trackers
Swiss Quality System, PEL & Swissmedic Interface
Support batch certification / release activities as delegated by the FvP (where legally permitted)
Review manufacturing, testing, and distribution documentation for GMP/GDP compliance globally for API Supply and Ex US finish goods and identify gaps requiring correction or escalation
Monitor GDP-compliant distribution operations (3PL oversight, warehousing/transport conditions, temperature monitoring and excursion management)
Support issue management and escalation across internal and external stakeholders
API Manufacturing Oversight & Supplier Onboarding
Ensure quality activities associated with onboarding and qualification of new API manufacturing partners.
Ensure quality oversight of external API manufacturers and key suppliers across the global network.
Support technical transfers, validation activities, manufacturing readiness, and launch preparedness.
Drive quality risk management activities related to API manufacturing and supply continuity.
Monitor supplier performance, inspection outcomes, deviations, CAPAs, and change controls.
Support supplier governance processes and long-term manufacturing network strategy.
Partner with CMC and Supply Chain to ensure continuity of global API supply.
Inspection Readiness, Audits, CAPA & Delegated Coverage
Support regulatory inspections and internal/external audits.
Drive CAPA implementation, effectiveness checks, and inspection readiness activities.
Act as FvP delegate during approved absences within the scope authorized by Swissmedic.
Ensure critical quality and supply risks are appropriately escalated.
Collaborate with Regulatory Affairs, Supply Chain, CMC, Clinical, CMOs, distributors, and service providers to provide operational quality input to supply and regulatory decisions.
Required & Desired Qualifications
BS+ in Pharmacy, Chemistry, Biology (or related)
10-12 years pharmaceutical Quality Assurance experience with Swiss/EU GMP/GDP exposure and quality system execution experience
Demonstrated experience overseeing API manufacturing operations, CMOs/CDMOs, and supplier quality management.
Eligible to act as Deputy FvP per Swissmedic requirements (FvP recognition preferred), with demonstrated inspection readiness support, documentation rigor, and cross-functional coordination, fluent in German and English
Strong knowledge of EU GMP, Swissmedic requirements, supplier quality management, and quality risk management.
Experience overseeing GDP distribution partners (e.g., 3PLs), including temperature monitoring and excursion management and partner governance routines
Key Competencies
Strong operational execution in regulated environments
Solid understanding of Swiss/EU pharmaceutical regulations
Attention to detail and documentation rigor
Effective cross-functional collaboration
Ability to operate under delegated authority with clear judgment and escalation discipline
Veeva Vault Quality (eQMS) proficiency to manage QMS workflows, document and inspection-ready evidence retrieval (as applicable)
We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.
Please note that this job description is not exhaustive and may evolve over time. Only shortlisted candidates will be contacted. Applicants must be authorized to work in the country of employment at the time of application. Employment terms, where applicable, will be governed by relevant collective bargaining agreements.
#J-18808-Ljbffr
