Director, Country Quality Head, US and Canada

The Role:

As Moderna continues its commercial growth, we are seeking an experienced Quality Assurance professional to lead our commercial and country quality activities in US.

As Director, Country Quality Head, you will be responsible to ensure the organization and oversight of the company's vaccine/pharmaceutical commercial operations are conducted in compliance with company standards and applicable FDA and Health Canada regulations. These operations include batch release, product quality complaints, recall, distribution, and corresponding storage conditions. As a quality partner to the commercial organizations, you will ensure appropriate QMS is in place and act as a bridge to the wider Quality network regarding advertising, clinical, Pharmacovigilance and promotional activities.

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.

Here’s What You’ll Do:

• Serve as Company's Management Representative

• Ensure Local Implementation, application, and maintenance of the company's quality system

• Lead preparation of Quality Reviews

• Lead monitoring and management review of Quality KPIs

• Develop and administer department budgets, schedules, and other administrative functions.

• Ensure Creation, update and application of procedural documents (SOPs)

• Lead preparation of internal and external audits, inspections, certifications, and monitoring of associated CAPAs for manufacturing (GMP)

• Support, as requested for GCP, GVP inspections

• Reporting to the Local Pharmaceuticals Agency any placing on the national market of a medicine which he considers to be falsified, for which he ensures the distribution.

• Lead local Risk analysis

• Ensure appropriate Complaint management

• Ensure appropriate Deviation management

• Management of vaccine/pharmaceutical subcontractors for local market: ensuring that the transportation conditions guarantee the appropriate conservation, integrity, and security of the products.

• Ensure implementation and monitoring of the distribution system (contracts, specifications, etc.)

• Ensure stock monitoring from a quality perspective (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.

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

• Bachelor’s degree in relevant scientific discipline

• Additional qualifications (MSc, PhD, MBA, Qualified Person) are advantageous

• +10 years significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)

• Working knowledge of relevant US, Canadian and international regulations

• Strong understanding of pharmaceutical business and quality governance

• Ability to work across multiple business functions to build consensus

• Experience leading team/budget (functional or project acquired experience)

• Experience in hosting and collaborating with national or international regulatory agencies

• Excellent interpersonal skills

• Outstanding communication skills (verbal and written)

• Ability 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 English (written and spoken) is essential

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you en