Manager, Non Clinical Quality

The Role

Reporting to the Director, R&D GLP/GCLP Quality, located at the Moderna Headquarters in Cambridge, MA, the Manager of Good Laboratory Practice/Good Clinical Laboratory Practice (GLP/GCLP), applies established knowledge and experience in internal, in-process, study and vendor audits.  The Manager should be familiar with global Health Authority Regulations including US FDA 21 CFR Part 58, any applicable GLP/GCLP international regulations, and GLP/GCLP guidance and is responsible for the oversight of Moderna Biomarker laboratory activities and associated bioanalytical analysis. The Manager will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it may require minimal travel for auditing vendors.

Here's What You’ll Do:

• Participate and actively engage in strategic initiatives which require GLP quality support.

• Provides continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to nonclinical and bioanalytical studies.

• Review/audit study materials, data and reports associated with nonclinical, pharmacological and bioanalytical studies.

• Plans, conducts and reports internal, in-process, study, and process audits. 

• Manages audit CAPAs and responses as per Moderna procedures. 

• Support regulatory agency inspections and vendor audits as needed.

• Contribute in the continuing development of a quality culture at Moderna.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications):

• BS/BA, or MS and a minimum of 8-10 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

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

• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP (understanding of regulatory guidelines for other countries a plus).

• Practical knowledge of GLP/GCLP related audits activities and business standards. 

• Bioanalytical technology, including but not limited to LIMS, PCR, plate reader, and mass spectroscopy proficiency is highly desired. 

• Expertise with business office applications, word processing and spreadsheets.

• Demonstrated knowledge and/or prior experience in Quality Assurance.

• Outstanding communication skills (verbal and written)

• Ability to manage multiple projects in a fast-paced environment.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.

• Relies on experience and judgment to plan and accomplish goals.

• Excellent organizational skills and keen attention to detail.

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

Travel Requirements 20%

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 insur