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Executive Director, Research & Development Quality Assurance (RDQA)Moderna Therapeutics • Cambridge, Massachusetts, United States
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Executive Director, Research & Development Quality Assurance (RDQA)

Moderna Therapeutics
  • US
    Cambridge, Massachusetts, United States
  • US
    Cambridge, Massachusetts, United States
Jetzt Bewerben

Über

**The Role:**Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in Cambridge, Massachusetts. Our head office here is more than just a global administrative center; it is a vital part of our efforts in pioneering mRNA technology and engaging in meaningful collaboration with the area's renowned universities and research institutions. In Cambridge, we aim to harness the wealth of knowledge and innovative spirit this region offers to further our global mission in medicine and healthcare. We are actively seeking talented individuals who are motivated by innovation and committed to making a significant impact. Join us at our Cambridge location, where your contributions will be pivotal in advancing our groundbreaking work in mRNA medicines and improving global health outcomes.This is a critical leadership opportunity for a seasoned Quality executive to shape and drive Moderna’s global R&D Quality strategy across all GxP domains. The Executive Director (ED), R&D Quality Assurance (RDQA), reporting to the Head of Quality, will set the strategic direction, governance model, and operational excellence framework for Quality within Research and Development. The ED will serve as Moderna’s most senior QA leader across GCP, GLP, GCLP and GVP, embedding proactive quality principles into the full R&D lifecycle — from research through to late-stage development. This role partners closely with Clinical Development, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety. With a strong emphasis on leadership, innovation, and transformation, this position is accountable for cultivating a data-driven quality culture, hosting global regulatory inspections, and leading a high-performing QA team based in Cambridge.**Here's What You’ll Do:****Your key responsibilities will be:*** Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s entire development portfolio.* Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna’s innovation agenda.* Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.* Embed risk-based quality management principles into study design, data generation, and vendor oversight practices.* Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings.* Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance.**Your responsibilities will also include:*** Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence.* Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops.* Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance.* Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness.* Oversee the Pharmacovigilance Quality System (GVP) including signal management, safety database validation, and global safety inspection preparation.* Collaborate with Global Systems & Compliance to maintain a fit-for-purpose R&D Quality Management System (QMS) that supports innovation and agility.* Monitor global regulatory intelligence and evolving external expectations, ensuring internal systems are updated accordingly.**The key Moderna Mindsets you’ll need to succeed in the role:*** **“We behave like owners. The solutions we’re building go beyond any job description.”**
In this executive role, you will serve as the quality conscience of Moderna’s entire R&D pipeline — with ownership of not just systems and metrics, but the culture, strategy, and mindset needed to make quality a competitive advantage.* **“We digitize everywhere possible using the power of code to maximize our impact on patients.”**
This role has a unique opportunity to modernize quality oversight by leveraging digital tools, automation, and data-driven insights — from vendor performance analytics to proactive issue detection in the clinical and non-clinical space.**Heres’ What You’ll Need (Basic Qualifications)*** Bachelor’s degree in a life science or related field; advanced degree preferred.* 18+ years of progressive Quality experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety.* 15+ years’ experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals.* Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability.* Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration.* Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes. Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation.* Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3).* Proven ability to collaborate and influence in a fast-paced, matrixed environment; strong cross-functional partnership skills with Clinical, Non-Clinical, PV, Regulatory, and Digital groups.* Exceptional leadership and people-development skills, with demonstrated ability to build and inspire high-performing, geographically dispersed teams.* Excellent strategic thinking, risk-based decision-making, analytical and communication skills* Agile and growth mindset; thrives in rapid growth and embraces continuous improvement and innovation.**Pay & Benefits****At Moderna, we believe that when you feel your best, you can do your best work.
That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.*** Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support* Family planning benefits, including fertility, adoption, and surrogacy support* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown* Savings and investment opportunities to help you plan for the future* Location-specific perks and extrasThe salary range for this role is $224,900.00 - $404,600.00. This is #J-18808-Ljbffr
  • Cambridge, Massachusetts, United States

Sprachkenntnisse

  • English
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