Senior Manager, External Quality Control
vor 15 Stunden
The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
The Sr. Manager, External Quality Control will oversee the planning, organizing, directing, and evaluating of routine external QC activities, including stability and project deliverables of external QC laboratories. This role ensures the safety and reliability of products manufactured in compliance with cGMP requirements.
Here's What You’ll Do:
- Developing and implementing an integrated QC oversight strategy for external QC testing networks for clinical and commercial programs.
- Ensuring on-time performance for QC testing at contract manufacturing organizations and contract laboratories, covering raw materials, drug substances, and drug products.
- Supporting cross-functional project teams in Quality Control-related activities and acting as a liaison with CMOs and contract testing labs.
- Following all relevant GxP regulations, guidelines, and company policies to ensure regulatory and internal compliance.
- Leading complex laboratory investigations to resolution with external testing labs and providing technical assessments for QMS activities, including deviations, investigations, and change controls.
- Monitoring and presenting key performance indicators (KPIs) for external QC testing networks.
- Managing the external testing QC budget and leading capital equipment requests.
- Driving continuous improvement initiatives (OpEx) within the external QC framework.
Here's What You’ll Bring to the Table:
- Education: Master’s degree in relevant scientific discipline
- Experience: 10 years of experience in the pharmaceutical/biotech industry within Quality Control
- Other Quantifiable Preference:
- Strong understanding of cGMP, regulatory requirements, and industry standards.
- Excellent management, analytical, and problem-solving skills.
- Proficiency with digital quality systems (e.g., LIMS, QMS, CDS).
- Strong written and oral communication skills, and ability to work effectively in a cross-functional matrix environment.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform. We believe in giving our people a platform to change medicine and an opportunity to change the world.
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