Manager Quality Assurance (QA) Operations, Italy

The Role:

As Manager QA Operations for Italy (reporting to the Snr Manager, QA Operations Team Lead), you will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.

Manager QA Operations will support Quality improvement initiatives and ensure robust processes and systems are implemented across Modernas international operations. The incumbent will provide person in plant QA presence at contract manufacturing organization (CMO) sites for oversight of drug substance and drug product fill finish activities and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls. The incumbent will be an integral partner to Modernas innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Heres What Youll Do:

• Provide person in plant QA presence at contract manufacturing organization (CMO) sites to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.

• Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).

• Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities.

• Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs and Contract Laboratory Organizations (CLOs).

• Review batch records, 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 and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.

• Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.

• Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Modernas drug substance and drug products.

• Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues.

• This role requires approximately 40% international travel.

Heres What Youll Bring to the Table:

• Bachelor degree, preferably in Sciences or Engineering or Pharmacy with applied Quality industry experience of 5-8 years ) for pharmaceutical industry, vaccines/biopharmaceutical experience preferred

• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.

• Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry.

• Experience in third parties oversight, hosting/facilitating successful regulatory inspections is a plus.

• Experience in cold chain monitoring applied to sterile product supply

• Fluency in English and Italian (spoken and written)

• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.

• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.

• Experience working with CMOs, CLOs, vendors, and relationship management preferred ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.

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

• Ability to navigate through ambiguity and rapid growth and adapt to change.

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

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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.

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