Sr. Manager, Global Stability Coe, Global Qc

**The Role**:
Reporting to the Associate Director, Global Quality Control (Commercial Stability CoE Lead), the Sr. Manager Stability, Global Quality Control (QC) will be responsible for supporting execution, harmonization, and integration of stability-related activities at internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)) organizations in compliance with Global QC processes, internal policies, procedures, and regulatory requirements.

This function will co-chair improvement initiatives supporting harmonization of processes, in close collaboration with other Moderna Stability functions and regulatory team.

The Sr. Manager Stability, Global Quality Control (QC) will oversee QC systems, policies, procedures, and controls as they relate to QC Stability testing of drug substances and drug product.

This function will be an integral partner to Moderna’s innovative technology platform to continue integrate automation and digital technology into stability related processes.

**Here’s What You’ll Do**:

- Author and review stability sections for health authority filings and annual product quality reports.
- Lead workstreams/projects for the digitalization of Stability and QC data.
- Create and maintain CTD stability updates plans to ensure submission timelines and regulatory commitments are met.
- Author and review applicable stability sections of Regulatory submissions.
- Create and Maintain stability KPI dashboards and reports metrics regularly for internal and external stability facilities.
- Lead the implementation of stability out of trend (OOT) process defining alert limits for commercial products.
- Lead the harmonization process for the stability studies in LIMS creating templates and working procedure for LIMS LabVantage 8.7.
- Create and maintain stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.
- Create and maintain internal database for post approval changes for commercial products.
- Update periodically the Stability Global share point with the stability relevant information.
- Author and review QC relevant procedures to support continuous improvements of systems (procedures and systems) to improve organization effectiveness and ensure compliance.
- Create and maintain the annual stability program monitoring process, for internal and external Stability facilities (planning, execution, and reconciliation), and create ad-hoc sections in the stability share point dedicated to the program.
- Review stability protocols and reports and participates in stability strategy and protocol design.
- Support stability related investigations and troubleshooting.
- Support Global Stability CoE to coordinate Moderna’s stability programs and relevant Change Controls.
- Co-chairing Moderna Stability review committee.

**Here’s What You’ll Bring to the Table**:

- Bachelor’s degree in relevant scientific discipline with a minimum of 8-10 years Quality Control experience in a Commercial/ Quality Assurance/ Quality Control Biotech or Pharma setting with a focus on Stability (preferable in life science or equivalent), including regulatory submissions. Fluent in written and spoken English.
- Deep understanding and experience with EU, US and ICH guidelines and regulations.
- Experience in managing stability programs and with stability data trending analysis.
- General experience in data analysis and statistical evaluation and trending of data.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.
- Proven ability to lead and manage projects of significant scope and complexity, meeting deliverables and timelines.
- Ability to travel up to 20% of the time.

**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 a research-stage company advancing programs in the field of messenger RN