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Manager, Supplier Quality Assurance

Moderna Theraputics

This is a Full-time position in Norwood, MA posted June 10, 2021.

The Role:Reporting to the Sr. Manager, Supplier Quality Assurance, Moderna is seeking a Manager of Supplier Quality Assurance for a position based at their Norwood, MA facility. This position is part of Moderna’s Global Quality Compliance team responsible for ensuring compliance within Moderna and support key compliance functions. The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Internal Quality, to ensure all aspects of global quality compliance are successfully executed.Here’s What You’ll Do:* Support quality agreement execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements.* Lead the supplier change notification process and ensure notifications are assessed for impact based on risk.* Support risk management activities including planning, design & risk assessment.* Apply statistical methods and design/process excellence tools to support global GxP compliance requirements.* Provide guidance in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.* Provide guidance in the understanding of regulatory reporting (BPDR, EU Defect) to other disciplines.* Tracking metrics & initiate quality improvement plans to address problem areas.* Reviewing and approve quality plans, support investigations to provide root cause analysis and ensure effective corrective actions are taken.* Track, manage and execute market actions and or product recalls.* Support and manage global escalations / notifications.* Ensuring compliance, and drive improvement plans where needed.* Host status update meetings, create/review status reports for key projects.Here’s What You’ll Bring to the Table:* BA/BS or MS in a scientific or engineering discipline* 5-8 years of experience in pharmaceutical / biotech industry with Quality Assurance exposure* Outstanding communication skills (verbal and written)* Ability to effectively collaborate in a dynamic, cross-functional matrix environment* Previous experience in a GMP environment is requiredHere’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)About Moderna:In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, 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. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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.#LI-KJ1*