The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that’s revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. 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. Moderna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients’ lives worldwide.
Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
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. The individual will assist in establishing testing program requirements and support investigations for out-of-specification, deviations, and other non-conforming results. Acting as an interdepartmental liaison, the Sr. Manager will interact with various groups within the organization and external QC contacts within contract manufacturing organizations and testing labs for raw materials, drug substance, and drug product.
Here’s What You’ll Do:Your key responsibilities will be:
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 up with CMOs and CTLs on reference standards, reagents, and on-time release and stability testing.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Following all relevant GxP regulations, guidelines, and company policies to ensure regulatory and internal compliance.
Executing tasks as defined in SOPs and work instructions with precision and adherence to Good Documentation Practices.
Completing mandatory training plans on schedule, adhering to requalification timelines.
Requesting data trending, analysis, and reporting from CMOs and CTLs to support quality oversight.
Developing QC capacity models based on manufacturing demand plans.
Reviewing and approving procedures, protocols, reports, and associated documentation.
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.
Interfacing with Health Authorities as needed to address QC testing inquiries.
Managing the external testing QC budget and leading capital equipment requests.
Driving continuous improvement initiatives (OpEx) within the external QC framework.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

We pursue options in parallel: In the role of Sr. Manager, External Quality Control, you will need to keep multiple QC oversight strategies and collaborations moving simultaneously to ensure all pathways for quality testing meet high standards and timelines.
We act with urgency: Given the impact of each product release and the essential role of quality control in patient safety, you’ll act promptly to ensure all QC activities are compliant, effective, and timely.