Sr. Specialist, Quality Assurance
5 mesi fa
**The Role**:
Reporting to the Associate Director (AD), QA Operations Team Lead - Drug Product, the Sr. Specialist QA Operations will be responsible for providing QA oversight and support external supplier as well as internal functions to ensure compliance with internal policies, procedures and specifications, and locally applicable regulatory requirements.
The Sr. Specialist QA Operations will support GxP activities at CMO sites for Moderna. 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, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls.
The incumbent will coordinate with internal/external network for management of Deviations, Complaints, CAPA and Change. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.
**Here’s What You’ll Do**:
Provide person in plant QA presence at contract manufacturing organization (CMO) sites to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.
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 and Contract Laboratory Organizations (CLOs).
Review batch records, testing 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.
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 substance and drug products.
This role requires approximately 20% national travel.
**Here’s What You’ll Bring to the Table**:
Bachelor’s degree, preferably in Sciences or Pharmacy
3-6 years’ experience of Quality or Production (including importation and distribution) for pharmaceutical industry, vaccines/biopharmaceutical experience preferred.
Working knowledge of relevant international and local regulations and standards/guidelines (ICH, cGxP, FDA).
Experience in third parties’ oversight, hosting/facilitating successful regulatory inspections is a plus.
Experience in cold chain monitoring applied to sterile product supply.
Fluency in English and Italian (spoken and written)
Excellent interpersonal skills and partnership attitude, using a team-oriented approach to ensure timely delivery of plan and resolve problem for complex issue in a scientifically sound and understandable way.
Attention to details, with ability to assess impact and cause/effect relationship in complex situation
Good communication skills (verbal and written) to operational and leadership employee levels, of external partners, suppliers, third parties, and industry organizations.
Ability to analyze, plan and manage multiple priorities 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.
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
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagin
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