The Role: Moderna is seeking a Senior Manager 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. 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 an 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 the 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.Provides 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.Collaborates/Supports with AS&T and development groups for method transfer and qualification activities as required.Assists in the development, implementation, and maintenance of general laboratory operational QC/IT systems in accordance with cGMP requirements.Interfaces 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 perform tasks as needed to maintain GMP compliance.Evaluates, aligns, and oversees QC data analytics, monitoring, and trending (e.g., method and product performance trending).Works with Digital/IT to continually 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 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...
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