Sr. Specialist, Quality Assurance - Italy

Moderna; Roma; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company in Italy is seeking a Sr. Specialist QA Operations to ensure compliance with quality standards at contract manufacturing sites. The ideal candidate should have a Bachelor's degree in Sciences or Pharmacy and 3–6 years of experience in the pharmaceutical industry. Fluency in English and Italian is required. The role offers a competitive benefits package and opportunities for professional growth.

Servizi

Quality healthcare and insurance benefits

Free premium access to fitness classes

Family planning and adoption benefits

Generous paid time off

Competenze

• 3–6 years’ experience in Quality or Production in the pharmaceutical industry.
• Working knowledge of international and local regulations and guidelines.
• Experience in cold chain monitoring applied to sterile products.

Mansioni

• Provide person in plant QA presence at CMO sites.
• Review and approve cGMP documentation.
• Manage CAPA for CMO activities.

Conoscenze

Fluency in English

Fluency in Italian

Interpersonal skills

Attention to detail

Communication skills

Formazione

Bachelor’s degree in Sciences or Pharmacy

Descrizione del lavoro

Overview

Reporting to the Associate Director (AD), QA Operations Team Lead - Drug Product, the Sr. Specialist QA Operations will be responsible for providing QA oversight and support external supplier as well as internal functions to ensure compliance with internal policies, procedures and specifications, and locally applicable regulatory requirements.

The Sr. Specialist QA Operations will support GxP activities at CMO sites for Moderna. The incumbent will provide person in plant QA presence at contract manufacturing organization (CMO) sites for oversight of 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 coordinate with internal / external network for management of Deviations, Complaints, CAPA and Change. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Responsibilities

• 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 initiated by CMOs and 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 Moderna’s drug substance and drug products.
• This role requires approximately 20% national travel.

Qualifications

• Bachelor’s degree, preferably in Sciences or Pharmacy
• 3–6 years’ experience of Quality or Production (including importation and distribution) for pharmaceutical industry, vaccines / biopharmaceutical experience preferred.
• Working knowledge of relevant international and local regulations and standards / guidelines (ICH, cGxP, FDA).
• 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 and partnership attitude, using a team-oriented approach to ensure timely delivery of plan and resolve problem for complex issue in a scientifically sound and understandable way.
• Attention to details, with ability to assess impact and cause / effect relationship in complex situation
• Good communication skills (verbal and written) to operational and leadership employee levels, of external partners, suppliers, third parties, and industry organizations.
• Ability to analyze, plan and manage multiple priorities 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.

Benefits

• 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

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagin