Sr. Director, Quality Assurance, Compliance at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



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 Do

• Continue to improve Moderna's 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 Moderna's 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.
  
  


• External engagement expected.
  
  


• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  
  
  

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options


• Flexible Spending Accounts for medical expenses and dependent care expenses


• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities


• Family care benefits, including subsidized back-up care options and on-demand tutoring


• Free premium access to fitness, nutrition, and mindfulness classes


• Exclusive preferred pricing on Peloton fitness equipment


• Adoption and family-planning benefits


• Dedicated care coordination support for our LGBTQ+ community


• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter


• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents


• 401k match and Financial Planning tools


• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


• Complimentary concierge service including home services research, travel booking, and entertainment requests


• Free parking or subsidized commuter passes


• Location-specific perks and extras!

About Moderna



Since 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.


As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.


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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!


Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.


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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.


Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.


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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)


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