Sr. Manager, Quality Assurance Operations, New

**The Role**:
Reporting to the Associate Director of Quality Assurance Operations DP for the International Organization, the Senior Manager QA Operations NPI will be responsible for providing QA oversight for implementation of new sites/ equipment in Moderna Facilities and QA oversight for qualification and process validation end to end and to ensure compliance with internal policies and procedures and specifications, regulatory requirements.

The Senior Manager QA Operations will support Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The incumbent will provide QA support for drug substance or drug product activities. Will oversee of drug substance or drug product sites 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 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 Quality support to the new sites projects in close collaboration with Global Engineering and local teams.

Review and approve design, master plan and risk assessments.

Review and approve 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).

Review and coordinate approval of all changes made to the manufacturing, testing and control processes.

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.

Manage End to End New Product Introduction by building network between Drug Substance and Drug Product platforms and coordinate Regulatory commitments responses with Regulatory CMC stakeholders.

Coordinate transversally alignment between Drug substances sites (internally or CMOs) or Drug Products sites (internally or CMOs).

This role requires approximately 40% international travel.

**Here’s What You’ll Bring to the Table**:
Minimum education requirement is a Bachelor’s degree, preferably in Sciences or Engineering or Pharmacy

Industry Experience of 8+ Years

Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.

Signification experience in qualification/validation.

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 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 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 includ