Senior Manager, External Quality Control

Moderna

Basel, Switzerland

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.

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;
Specific Certifications or Training: None;
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;
- Detail-oriented, organized, and capable of managing multiple projects in a fast-paced environment;
- Technical writing and ability to present results;
- Strategic Vision and Influence Capability;
- Experience leading continuous improvement projects in testing laboratories.