Supervisor, Quality Assurance, Facilities And Engineering

The Role:
Moderna is seeking a Quality Assurance Supervisor to lead a team of QA Specialists responsible for providing quality oversight of the Facilities and Engineering groups (F&E) at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA.
This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of F&E, with a focus on quality system records, CMMS records, and general F&E documentation/drawings. Strong decision-making skills and independent thinking will be paramount for candidate success. In addition to supporting F&E, this individual will work closely with Manufacturing, MS&T, Validation, QC, and other Quality units.
Here’s What You’ll Do:
Manage a team of QA Specialists responsible for providing quality oversight of the Facilities and Engineering groups. (e.g., Maintenance, Metrology, Process ENG, Project ENG, and CMMS team)
May support the Validation group in conjunction with QA Validation team.
Coordinate training, professional development, and growth of the Quality Assurance F&E team. Additionally, advise and coach team on day-to-day tasks/projects.
Provide Quality oversight of the Computerized Maintenance Management System (CMMS). Review and approve: Work Orders, PM Records, Calibrations, Asset Records, Cal/PM Extensions, Out of Tolerance records, etc.
Review and approve F&E procedures, policies, work plans, protocols, GMP/GEP Drawings, and forms.
Oversee the Alarm Management process. Review and approve critical facility and temperature unit alarms.
Provide Quality oversight of commissioning, qualification, and maintenance activities.
Identify, classify, and report deviations, as appropriate, and typically works on more complex minor and/or major deviations.
Support the change management process for F&E projects (i.e Change Controls, Facility Master Plans, facility/critical utility modifications)
Identify risks and communicate gaps for quality and GMP process/systems.
Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed.
Ability to manage multiple projects in a fast-paced environment.
Collaborate and lead effectively in a dynamic, cross-functional matrix environment.
Author and review SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
Here’s What You’ll Bring to the Table:
6 years of experience in a GMP manufacturing environment, preferably within Quality, with a Bachelor’s Degree in Engineering, Maintenance Technical degree, Sciences, or related field.
Proven track record of success in a fast-paced production environment at a GMP biotech/pharmaceutical company.
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Outstanding communication skills (verbal and written).
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:

• Paid sabbatical after 5 years; every 3 years thereafter
• Volunteer time to participate within your community
• D iscretionary year-end shutdown
• Vacation, sick time and holidays

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
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 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)
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