Sr. Specialist (Lead Auditor) - Quality Systems and Compliance - External
ModernaTX, Inc.

Job Info

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The Role:
Reporting to the Associate Director, Quality Systems and Compliance - External, Sr. Specialist/Lead Auditor will coordinate, lead, and participate in audits of External Manufacturing Quality Management Systems to assess compliance with all applicable domestic and international regulations and standards.

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 the best talent in the industry.

Here's What You'll Do:

• Prepare, plan, and coordinate effective and efficient GxP quality compliance audits
  
• Assess the site or function's ability to operate freely and communicate the assessment results
  
• Assess Moderna's External Organizations state of compliance with applicable regulations and lead / participate in the assessment of action plans to remedy deficiencies.
  
• Provide leadership for the Inspection Management program to resolve site and multi-site compliance issues resulting from inspectional audit findings. Provides technical support/compliance review of multi-site/global documents resolving compliance issues.
  
• Support domestic and international Regulatory Authority Inspections and Notified Body Audits.
  
• Collaborate with functional leads to ensure that Moderna Standards, strategies, and direction are aligned with existing standards, regulations and regulatory expectations.
  
• Support Continual Improvement initiatives, programs, and projects.
  
• Partner to resolve deviations, CAPAs, and effectiveness verifications related to audit findings.
  
• Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines, standards, rends and expectations).
  
• Review, provide feedback, and approve audit reports.
  

Here's What You'll Bring to the Table:

• Doctorate degree and 3 years of Quality, Regulatory, Compliance or Operations experience OR Master's degree and 6 years of Quality, Regulatory, Compliance or Operations experience OR Bachelor's degree and 8 years of Quality, Regulatory, Compliance or Operations experience
  
• Detailed experience and knowledge of partnering with manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, data integrity.
  
• Lead auditor certification (i.e. ASQ).
  
• Subject matter expert on global regulatory requirements and standards .
  
• Current up to date knowledge on the latest standards, regulations, and industry trends related to medical devices and APIs.
  

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

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 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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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