Associate Director, Quality Control - Madrid, España - Moderna Therapeutics

Moderna Therapeutics

Empresa verificada

Madrid, España

hace 1 semana

Publicado por:

Isabel García

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Descripción

The Role:

Moderna is seeking an Associate Director for a position based at their new Madrid, Spain, site.

The individual in this role will directly oversee commercial testing functions in the Quality Control department in support of raw materials, drug substances and drug/finished products testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations.

Also, this individual may support related method transfer, qualification and validation activities and assist in the development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.

He/she will also manage a group of laboratory personnel and oversee performance management, mentoring and career development.

The individual will act as interdepartmental liaison to various groups including AS&T, Global QC, External QC International, Quality Assurance and Regulatory.

Here's What You'll Do:

Oversees day-to-day operations of the Quality Control commercial program testing functions, including stability

Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development

Assists in development of appropriate Standard Operating Procedures, laboratory data collection & documentation systems (paper and electronic) and training of personnel to ensure cGMP compliance

Supports laboratory investigations, change controls, and CAPAs for relevant QC operations

Contributes to budget planning and resource allocation

Provide testing data and other required quality-related information needed to support product studies

Interacts with AS&T, Quality Assurance, Regulatory Affairs, and other Departments to:
Support testing for drug substance and drug product internally and at CMOs and contract laboratories.

Provide testing data and other required quality-related information needed to support stability programs, APQR

Collaborates/Supports with AS&T and development groups for method transfer and qualification activities as required

Assists in development, implementation, and maintenance of general laboratory operational QC/IT systems in accordance with cGMP requirements

Interface with health authorities to support site and external inspections as required

Troubleshoots issues related to laboratory procedures and assay performance

Provides support to audit teams for Health authority, Internal/External and vendor audits

Ensures teams performs tasks as needed to maintain GMP compliance

Evaluate, align, and oversee QC data analytics, monitoring, and trending (e.g., method and product performance trending).

Works with Digital/IT to c ontinually strengthen data integrity across the QC testing laboratories.

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

Minimum education required:
Bachelor's Degree in a relevant scientific discipline

Minimum experience required: 10 + years in applied industry experience; 4-6 years of management/supervisory experience

Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs

Previous supervisory experience is preferred, including testing scheduling and lab project management.

Minimum knowledge required:
general laboratory operations, method acquisition, qualification.

Minimum skills required:

Technical writing

Proficiency with Microsoft Office Programs

Familiarity with electronic databases (e.g., LIMS, SAP, LMS)

Familiarity with QC operations including bioassay, chemistry, and microbiology

HPLC Instrumentation/ Software experience is preferred

Strong written and oral communication skills as well as organizational skills

Knowledge of industry standards and guidelines, experience supporting compliance audits.

Demonstrated ability to work effectively under established guidelines and instructions

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

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 transf