Associate Director Global Cmc Quality Operations

vor 2 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Director, Product Quality Lead the Associate Director, Product Quality Lead will be responsible for developing, approving, monitoring and maintaining critical quality standards, identifying quality risks, ensuring quality management of product and processes lifecycle, leading improvement and alignment with current regulatory expectations.

The individual will ensure robust processes are implemented across Moderna’s global operations for management of product and process lifecycle quality (control strategy, technology transfer and changes, process validation lifecycle, (quality monitoring). The individual will partner cross-functionally with Supply Chain, Manufacturing Sciences & Technology, Manufacturing, Digital and Regulatory as the Quality representative. This role will entail representation at the change review board(s) to operationalize strategic projects including product launch in support of Moderna’s CMC programs.

**Here’s What You’ll Do**:
Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Moderna’s vaccines and therapeutics

Develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical Transfer and Control Strategy, in collaboration with Technical Development (TD), Manufacturing Sciences & Technology (MST), Regulatory Affairs (RA), Quality Control (QC), Quality Assurance (QA), Manufacturing (MFG) and Facilities and Engineering (F&E).

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

Coordinate APQR process execution within network of internal, external and international partners to ensure appropriate documentation are delivered in a timely manner

Provide quality support for significant changes and issue management (deviations/CAPAs) across Moderna’s internal and external manufacturing and testing sites

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

In collaboration with the quality systems business process owners and site quality operations team, 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

**Here’s What You’ll Bring to the Table**:
Bachelor’s 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 supporting successful regulatory inspections.

A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.

Practical experience with Quality Risk Management lifecycle.

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 winter break
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 diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

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