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Quality Assurance Manager

il y a 2 semaines

Paris, France Moderna Temps plein

**The Role**:
Reporting to the Director, Regulatory Affairs the Country Quality Manager 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 Country Quality Manager will support compliance of warehousing and supply chain in France with Moderna and regulatory requirements. The incumbent will coordinate with operations and oversee execution of Moderna’s and external suppliers’ activities in compliance with applicable Good Importation, Good Distribution and Good Supply practices. Acting as primary point of contact for local authorities, he/she will edit, submit, review and/or approve documentation related to importation, distribution, and supply. 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.

**Here’s What You’ll Do**:

- Support delivery of Moderna’s products in/from France in compliance with applicable Good Importation/Distribution/Supply practices (GIP, GDP, GSP).
- Edit and submit summary protocols to support release of products as per applicable international/local regulations
- Coordinate with Quality Control of national lot release testing and distribution operations, ensuring data and documentation are complete, accurate and submitted in due time to meet Moderna’s commitments
- Be the point of contact of local regulatory authorities, coordinating effective and efficient communication with internal/external network of experts
- Ensure QA presence at Third Parties in France for adherence to approved policies, SOPS, quality agreements, batch records, regulations
- Provide QA oversight to ensure compliance with approved quality agreements and overall GIP/GDP/GSP compliance for Moderna’s products.
- Support/contribute to quality investigations of deviation and complaints, and to development of CAPA (corrective and preventive actions)
- Batch release for distribution in France and tracking/traceability
- Batch recall management with marketing authorization holder, Health authority and wholesaler
- Ensure timely documentation, notification/escalation and resolution risks or issues in scope.
- Conduction of regular audits of internal pharmaceutical activities (drug safety, medical information, promotion process, complaints, etc.)
- Review and approve documentation related to importation, distribution, and supply, as appropriate
- This role requires non-routine day travel for oversight of local service providers.

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

- Bachelor degree, preferably in Sciences, Pharmacy or logistics.
- 6-9+ years’ experience of Quality management of supply chain (including importation and distribution) for pharmaceutical industry in France, vaccines/biopharmaceutical experience preferred.
- Working knowledge of relevant international and local regulations and standards/guidelines (good importation practices, good supply practices and good distribution practices).
- 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 French (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.

**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 winter break
- Edu