Manager, Quality Assurance Bardi

Manager, Quality Assurance
Bardi
Emilia Romagna, Bardi

A request:

For this role it is essential to speak both Italian and English.

However, as English is our internal business language, we ask that all CVs / resumes are submitted in English.

If a CV is not submitted in English, it will not be considered.

Thank you!

**Una richiesta:

Per questo ruolo è essenziale parlare sia italiano che inglese.

Tuttavia, poiché l'inglese è la nostra lingua commerciale interna, chiediamo che tutti i CV / curriculum siano presentati in inglese.

Se un CV non è presentato in inglese, non sarà preso in considerazione.

Grazie!

*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 Moderna's 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 Moderna's innovative technology platform as we continue to integrate automation and digital technology into everything we do. Here's What You'll Do:

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