Sr. Manager, QS and Compliance

The Role:

Reporting to the Associate Director Quality Systems and Compliance, the Senior Manager Quality Systems and Compliance will be responsible for leading implementation of quality system processes and operations to ensure Moderna exceeds the highest level of compliance while monitoring the health of the Quality Management System (QMS) for continuous improvement in support of the US external organization. The Associate Director will participate in internal, supplier quality and health authority audits, support document control, training and records management and assist in building a culture of quality at the site and oversee Modernas QMS in support contract testing and manufacturing facilities and overall US operations for Moderna clinical and commercial products.

Heres What Youll Do:

• Support implementation and management of Modernas overall Quality Management System (QMS) and quality manual, policies and procedures for the international organization and ensure continuous improvement while keeping it current with emerging and changing regulations, guidance documents and current industry best practices and expectations.

• Lead Compliance governance activities such as but not limited to Quality Management Review and regional and local Change Control Review Boards.

• Oversee the performance of Modernas QMS monitoring the state of control through metrics and key performance indicators for Modernas international organization and CMOs.

• Perform audits in support of the internal and supplier quality audit programs and support and/or host third party/regulatory inspection programs.

• Implement practices in document and records control, management, and retention to ensure robust training, compliance, data integrity, and continuous improvement for the rapidly expanding GXP international environment.

• 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.

• Work collaboratively with the digital team on the GXP integrated digital landscape to support all e-systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.

• Provide cross functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations.

• This role requires limited travel.

Heres What Youll Bring to the Table:

• BS in a scientific or engineering discipline with at least 10 years experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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