Associate Director, Product Quality Lead

vor 1 Woche

Basel, Schweiz Moderna Therapeutics Vollzeit

The Role
Critical Raw Material (CRM) play an essential role for our Product Quality impacting across all our programs.
Reporting to the Sr Director - Product Quality, the A/Director - Product Quality Lead (PQL) will be responsible for providing end-to-end quality oversight to our critical raw material.

Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality risks related to CRMs. Ensures quality management and lifecycle management, leads improvement, and in alignment with current regulatory expectations.

The individual as single contributor will ensure robust processes are implemented across Moderna’s global operations for management of clinical and commercial product and process lifecycle quality (control strategy, technical transfer and changes, process validation lifecycle, quality monitoring). The individual will partner cross-functionally with CRMs QA team, Technical Development, Regulatory, Supply Chain, Manufacturing Sciences & Technology, Manufacturing and Digital as the Global Quality representative on relevant CMC Governance Boards to enable efficient communication and strategic decision-making.

**Here’s What You’ll Do**:
Provide end-to-end quality oversight and strategic guidance throughout the CMC lifecycle management.

Interface in a matrix environment to develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical Transfer and Control Strategy.

Ensure significant Quality risks are escalated and mitigated in a timely manner

Approve technical protocols, reports and risk assessments, specifications, submissions documents & support the knowledge management workstreams.

Contribute, Review and Approval of Source Documents used in the creation of CTD sections (Tier 1)

Contribute, review and approve RtQ to Health Authority questions and ensure execution of associated commitments

Drive or support significant changes and issue management (Deviations/CAPAs) across Moderna’s internal and external manufacturing and testing/stability sites

Coordinate quality activities related to product launch with other QA functional groups

Contribute to improvement and harmonization initiatives across Global Quality Operations in line with current Regulatory expectations.

In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement of new and emerging technologies to ensure quality and compliance frameworks are established

In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes

Mobility 10-15%

**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years; 8+ with MS.

Extensive experience in raw material management (either QA or QC)

Knowledge in risk management, and quality system requirements.

Working Knowledge in CRMs pharmacopea (USP, JP, Ph EUR)

Knowledge in management of single use process aids is a plus.

Capacity to work in dynamic range from deep dive to establishing big picture.

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

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.

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 year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a div

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