Manager Global Quality Design amp Development

Profile

The Role:

The Manager, Global Quality, Design & Development will be responsible to provide Quality oversight of design and development of products. This position will be located in Norwood, MA.

Here’s What You’ll Do:

• Partner with design and development teams to ensure quality is designed into the products

• The successful candidate will work directly with scientists and analysts in the development labs to create the most compliant and efficient lab practices

• The candidate will use previous knowledge of regulations (FDA, EMA, MSAP, etc.) to provide timely guidance to product development teams

• Knowledge of GxP, ISO, ICH and experience working in a regulated pharmaceutical, biotechnology or medical device company

• Review and approve the design development plans, protocols and reports, as the quality approver

• Identify and escalate quality risks to products in development to the appropriate level

• With the cross-functional Filing Team, support regulatory filings  

• Provide hands-on support to product development labs

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

• Bachelor of Science degree with 5+ years of experience or equivalent

• Master of Science degree with 2+ years of experience or equivalent

• Working knowledge of applicable FDA, EU regulations and ICH standards/guidelines applied to development of process or analytics.

• Experience with quality systems and electronic systems in a biopharma organization

• Working knowledge of validation is preferred

• Experience of new product launch is preferred.

• Involvement with deviation/CAPA/change control 

• Skills in Good Documentation Practices, Data Integrity

• Ability to interact effectively with operational organizations and leadership at all levels of the organization

• Experience in leading or contributing to technical projects/teams

• Excellent interpersonal skills using a team-oriented approach to problem solve for issue resolution using a scientifically sound approach. 

• Sound collaboration and communication skills (both verbal and written) 

• Ability to navigate through ambiguity, rapid growth, and adaption to change.

• Ability to be agile in a dynamic, cross-functional matrix environment.

• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

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, Moderna has 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. 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. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit ****target=_blank rel=no-follow>****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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