Director quality assurance compliance

In this role, you will be responsible for providing compliance strategy, expertise and recommendation to the business partners within the CMC, digital, commercial networks, and serve as the liaisons with regulators within the assigned markets for all compliance related matters, post marketing compliance risks, ensuring escalation and follow up of compliance related plans.Here's What You'll DoContinue to improve Modernas overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.Define standards for compliance and evolve a Moderna Compliance Strategy that ensures consistency and alignment across Global Quality, CMC and country organizations.Own and execute Global Compliance Processes, including the inter-network compliance council.Provide cross functional quality leadership and act as a subject matter expert on technical matters involving quality investigations, validation, data integrity, cGMP compliance, and in compliance matters involving facility and laboratory operations.Evaluate business goals, identify improvement opportunities, and apply scientific methods, statistics and problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.Manage the compliance performance and effectiveness of the quality system elements: such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.Assure implementation of global compliance plans based on compliance assessments.Support the internal audit program and third party/regulatory inspection programs for Modernas GxP teams as necessary.Prioritize and foster an overall inspection management program guidelines and standards. Provide input to compliance related communications assuring a global mindset and impact.Provide guidance and direction to employees in alignment with organizational strategies and priorities.Inspire and motivate team members to achieve their full potential.Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.Area of responsibility is North America and APAC region.Deputize other Sr. Compliance Advisor and/or Department Head as needed. Additional duties as may be assigned from time to time.Here's What You'll Need (Basic Qualifications)BS or MS in a scientific or engineering discipline.12+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including QA, QC, Validation, Test Methods, Manufacturing and process engineering.Here's What You'll Bring to the Table (Preferred Qualifications)Proven leadership experience managing complex global compliance functions/issues.Extensive and proven engagement with global regulatory authorities on compliance matters, minimally with FDA and EMA.Demonstrated understanding of international GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards) and ability to translate and communicate these requirements into practical applications.Prior Quality Audit, and/or QP/RP experience desirable.A desire to make an impact as part of a high-growth, transformational company that is

Bold, Relentless, Curious, and Collaborative.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at ***************@modernatx.com. (EEO/AAP Employer)

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