Sr. Specialist, Quality Assurance Operations - Sacile, Italia - Moderna Therapeutics
Descrizione
The Role:
Reporting to the Senior Manager Quality Assurance (QA) Operations - Drug Product Team Lead for the International Organization, the Sr Specialist QA Operations will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.
The Sr Specialist QA Operations will support manufacturing and release at CMO's site and ensure local cGMP and Moderna policies are effectively applied.
The incumbent will provide person in plant QA presence at contract manufacturing organization (CMO) sites for oversight of drug product fill finish activities and support review and approval of all cGMP documentation including policies/SOPs, testing data, deviations, CAPA and Changes Controls The incumbent will participate to the transfer of product to the CMO's site under the supervision of the Sr Manager or Manager QA.
Here's What You'll Do:
Provide person in plant QA presence at contract manufacturing organization (CMO)
Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities.
Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs
Review batch records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.
Collaborate with the Manager Operations QA to review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.
Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna's drug products.
Here's What You'll Bring to the Table:
Bachelor degree, preferably in Sciences or Pharmacy or Engineering with applied Quality industry experience of 2-5 years.
Working knowledge of relevant EU and global regulations.
Experience in sterile manufacturing, packaging and testing Experience in CSV and validation is an advantageous.
Fluency (written / spoken) in English and Italian - fluency in other languages is advantageous
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) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
Ability to navigate through ambiguity and rapid growth and adapt to change.
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.
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.
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.
Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.
Most recently, Moderna's capabilities hav
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