Associate Director, Microbiology - External Quality Control

Moderna

Basel, Switzerland

The Role

In this role, you will oversee QC microbiology activities at contract manufacturing and testing organizations globally, leading QC raw material, drug substance, and finished product testing to ensure compliance with internal policies, procedures, and regulatory requirements. You will provide microbiology expertise, lead the microbiology experts group, and drive improvement initiatives across Moderna’s External QC operations. This role will be critical to ensuring robust quality control processes as Moderna continues integrating automation and digital technology. You will also take charge of microbiology-related issues, deviations, and gap remediation activities.

Here's What You’ll Do

Your key responsibilities will be:

Lead QC microbiology activities at contract manufacturing and testing organizations globally (USA, Europe, Asia), including implementing microbiological testing capabilities, method transfer, validation, and qualification activities;
Provide microbiological expertise to support environmental monitoring programs and manufacturing operations, contributing to microbial control risk assessments, product impact assessments, and changes;
Lead complex investigations and troubleshooting of microbiological methods to support QC operations and ensure timely resolution and escalation;
Review, approve, and implement cGMP documentation (policies/SOPs, microbiological test methods, protocols, etc.);
Lead laboratory investigations related to testing activities, including OOS/OOT, CAPA, Deviation, Gap Remediation, and Change Controls;
Collaborate with Regulatory CMC teams to ensure regulatory commitments are met and timelines are maintained.

Your responsibilities will also include:

Perform proactive surveillance of global regulatory requirements;
Collaborate with contract facility personnel and internal subject matter experts to resolve QC testing issues;
Lead, coach, and develop a global team of microbiology experts;
Collaborate with Manufacturing, Science and Technology (MS&T), Quality Assurance (QA), Supply Chain, and CMC Teams;
Travel internationally (~15%).

The key Moderna Mindsets you’ll need to succeed in the role:

Prioritize the Platform: Your ability to focus on the platform over any single product will be vital in driving QC microbiology advancements that support Moderna’s broader mission;
Question Convention: You will challenge the status quo by applying innovative solutions to overcome complex microbiological quality control challenges.

Here’s What You’ll Need (Basic Qualifications)

Bachelor’s degree in relevant scientific discipline with minimum experience of 10-12 years within the industry and quality control with a focus in microbiology;
2-3 years management/supervisory/lead experience in cGMP organization.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Working knowledge of relevant EU, FDA and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections;
Experienced in executing microbiological quality control testing, method transfers and validation within a biotechnology industry;
Experience with rapid microbiology methods (preferred);
Fluency (written/spoken) in English – fluency in other languages is advantageous;
A proven track record of success in managing quality control projects with external testing sites in a biopharma organization;
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) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations;
Experience working with CMOs, CLOs, vendors, and relationship management preferred;
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment;
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment;
Ability to navigate through ambiguity and rapid growth and adapt to change;
A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo;
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.