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Senior Manager, Quality Assurance Systems and Compliance

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
May 22, 2024

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Job Details

The Role

This role is an exciting opportunity to be a part of the Quality Assurance organization. Moderna is a growing organization with a state-of-the-art cGMP manufacturing facility in Norwood, MA, USA. The site focuses on manufacturing early phase and commercial product. As the company grows, the Quality Assurance is looking for talented individuals with a strong Quality Culture mindset and ability to adapt to a fast-paced environment. This role will be supporting many of the responsibilities listed below and will be expected to collaborate with cross-functional departments to maintain and enhance compliance at the Norwood site.

We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.

Heres What Youll Do

  • Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity via maintenance and execution of Quality Management Review and Site Quality Council governance forums.

  • Support the establishment and reporting of quality metrics for cGMP related functional areas.

  • Author and review SOPs and Policies to ensure compliance and adherence to regulations/cGMP operations.

  • Author, review, and approve Annual Product Quality Reviews (APQR) and other trend reports.

  • Partner cross-functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees.

  • Continue 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.

  • Provide compliance guidance and training through various methods including formal and informal presentations and trainings.

  • Identify opportunities for quality system improvements.

  • Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.

Within 3 Months, You Will

  • Complete required onboarding and training programs, familiarize with company policies, procedures, and quality systems.

  • Start developing relationships with key stakeholders.

  • Understand the current state of compliance and quality systems.

Within 6 Months, You Will

  • Participate in development of strategic plans for quality system and compliance improvements.

  • Establish regular communication channels for updates and feedback.

  • Fully own coordination and execution of Quality Management Review and Site Quality Council meetings.

Within 12 Months, You Will

  • Act autonomously to identify compliance risk and continuous improvement opportunities.

  • Demonstrate tangible improvements in quality systems and compliance metrics, establish yourself as an influencer within the organization, and contribute to broader organizational goals and initiatives beyond the quality systems and compliance realms.

Heres What Youll Need (Minimum Qualifications)

  • Bachelors degree with a minimum of 10 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.

  • Fluent in written and spoken English.

  • Experience in data analysis, statistical evaluation, and trending of data.

  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.

  • Understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.

  • Ability to interact effectively with all levels of personnel within the organization.

  • Ability to navigate through ambiguity and rapid growth and adapt to change.

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

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Masters degree with a minimum of 8 years of experience in the pharmaceutical industries or Ph.D. with a minimum of 5 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.

  • Deep understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.

  • Advanced experience in data analysis, statistical evaluation, and trending of data.

  • Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.

  • Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).

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, theinfrastructure 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 peopleare 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. Were 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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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
US

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