Associate Director, Risk Management

**The Role**:
The Associate Director of Risk Management, will partner closely with the Director of Risk Management and Metrics and the Director of Quality Systems to establish and oversee a Global Quality Risk Management system across Moderna that periodically identifies, evaluates, levels, and mitigates all the GxP related risks across the organization.

The leader will help ensure that the most critical Quality related risks with significant impact to the business are collected and presented to leadership with impact understood, and mitigations plans defined to support appropriate action.

**Here’s What You’ll Do**:
Oversee the establishment of the Quality Risk Management (QRM) framework, consistent with ICH Q9 and ISO14971 to enable monitoring and risk resiliency across Moderna’s global network and manufacturing footprint

Design and implement an overall Quality risk management process for Moderna, which includes identification and analysis of all GxP related risks and their impact on the company

Responsible to provide to the Quality Leadership Team an accurate and efficient Quality Risk Management approach that supports Moderna to define their priorities and strategy for all GxP areas

Act as the Global Process Owner, define the standard and ensure broad understanding across the business

Develop and lead a community of practice and community portal for risk experts to share knowledge. Provide expertise in the development of risk-based approaches in support of the quality management system

Partner with other Quality System owners to drive effective risk management strategies, monitoring and reporting

**Accountable for reporting on a Quality risk assessment**: analyzing current GxP risks across the organization and identifying potential risks that are affecting the company

**Accountable for performing periodic Quality risk evaluation**: evaluating the company’s previous handling of risks, and comparing potential risks with criteria set out by the company, such as Compliance and regulatory risks combined with business, legal, reputational, and financial costs

Establish and support active monitoring of risk tolerance with Global Quality Leadership Team to drive appropriate mitigation strategies on GxP risks

Liaise with Corporate Compliance team to ensure that Quality Risks are addressed and collected on the overall Risks identified at Moderna corporate level

Oversees the definition and tracking of an action plan to reduce each one of the Quality related risks to the agreed level of risk

Supports the development of a robust inspection readiness program, champion an inspection ready approach and ensure documentation generation and maintenance to support successful inspections

Provide active support during regulatory agency and third-party inspections and help ensure observations are addressed and completed to the agreed schedule

Reports status of process performance and ensures timely and accurate metrics for presentation; includes day-to-day operations, program health, status, and action, as well as management review (Right to Operate)

Accountable to prepare and present the Quality Risk to leadership, summarizing risks to the business and potential consequences and the proposed actions to reduce those risks

Explain the external risk posed by corporate governance to stakeholders etc.

Build external partnerships across industry and with regulators to anticipate industry trends

**Here’s What You’ll Need (Minimum Qualifications)**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years; 8-10 with MS

Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in overseeing Quality Risk Management

A proven track record of success in implementing and maintaining a Global Quality Risk Management system and related tools overseeing all QRM across the company

Excellent ability to manage data analytics and statistics

Ability to interact effectively with all levels of personnel within the organization and key stakeholders.

Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines

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)

Ability to navigate through ambiguity and rapid growth and adapt to change

Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment

A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo

VEEVA QRM or other industry standard QRM tools experience, a plus.

20% travel expected

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

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