Director, Country Head Quality Assurance Lazio

Director, Country Head Quality Assurance
Roma
Lazio, Lazio

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 essenziale parlare sia italiano che inglese.

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

Se un CV non presentato in inglese, non sar preso in considerazione.

Grazie!

*The Role:

As Moderna continues its international growth, we are seeking an experienced Quality Assurance professional to lead our in-country QA activities across Italy and Greece.

As Director, Country Head, Quality Assurance, you will be responsible to ensure the organization (and monitoring) of the company's vaccine/pharmaceutical operations are conducted in agreement with company standards and applicable regulations.

These operations range from manufacturing, distribution, advertising, information, product quality, batch monitoring and recall, to the corresponding storage operations, where appropriate.

Working in collaboration with Global and Local Quality Heads, you must ensure that all vaccine/pharmaceutical related activities are conducted in the respect of applicable:

Good Practices (GxP);Procedures (Policies, SOPs);Marketing authorization;Contracts and quality technical agreements. We are seeking for this person to be bold in suggesting new and innovative process and systems improvements working in a highly collaborative way (that maintains a flat organization and supports fast decision-making) you will be relentless in your pursuit of excellence. If you are forward-thinking, dynamic in your outlook, and attracted to a challenge which is demanding and rewarding this is your next step. Heres What Youll Do:

ensuring that the transportation conditions guaranteethe appropriate conservation, integrity and security of the products. Ensure Monitoring of medical samplesEnsure implementation and monitoring of the distribution system (contracts, specifications, etc.

)Ensure stock monitoring (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.

)This list is non exhaustive.

Other missions may be added. Heres What Youll Bring to the Table:

Bachelors degree in relevant scientific disciplineAdditional qualifications (MSc, PhD, MBA) are advantageous+10 years Significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)Working knowledge of relevant local and international regulations and ICH, ISPE, ASTM standards/guidelinesStrong understanding of pharmaceutical business and quality governanceAbility to work across multiple business functions to build consensusExperience leading team/budget (functional or project acquired experience)Experience in hosting and collaborating with national or international regulatory agenciesExcellent interpersonal skillsOutstanding communication skills (verbal and written)Experience working with CMOs, CLOs, vendors preferredAbility to conceptualize, analyze, plan and manage 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. Language skills:

Fluency in Italian and English (written and spoken) is essentialFluency / Knowledge of additional languages is advantageous but not essentialAbout ModernaIn 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, Modernas capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic. Modernas 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. Moderna is a smoke-free, alcohol-free and drug-free work environment. #LI-AS5-Full time