Director, Quality Assurance at ModernaTX, Inc.

Posted in Other 7 days ago.

Location: Norwood, Massachusetts





Job Description:

The Role



Moderna is seeking a Director to lead a team of QA personnel responsible for batch record review and product disposition for internal commercial manufacturing at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA.


The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally at Moderna. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical and commercial products. Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and management in Manufacturing, and cross-functionally with Quality Control, Logistical and Process Development Technology Transfer counterparts.



Here's What You'll Do



  • Oversee teams responsible for batch record review and commercial product disposition.


  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)


  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met


  • Review and approve validation protocols and reports to ensure compliance


  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans


  • Support disposition of raw materials, drug substance, and drug product


  • Identify, hire, and mentor QA staff


  • Communicate budget, project requirements and issues to Quality Management


  • Support implementation and oversight of electronic batch record platforms.





Here's What You'll Need (Minimum Qualifications)



  • BS or equivalent and a minimum of 10 years laboratory experience, or a Master's level degree and a minimum of 8 years experience in the pharmaceutical/biotech industry


  • 10 years experience in Quality Assurance in a pharmaceutical/biologic firm, with a minimum of 4 years in a management role.





Here's What You'll Bring to the Table (Preferred Qualifications)



  • 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 winter shut down
    • 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 person's 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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