Associate Director, Sterility Assurance

**The Role**:
Reporting to the Sr. Director of Global Quality Control, the Associate Director, Sterility Assurance, will be collaborating closely with Moderna’s network of Microbiological Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), providing guidance and direction about the main following topics (not exhaustive):
sterility assurance governance programs (policies, standards and procedures, validation strategy design);
harmonization/optimization of multi-site microbiological processes (e.g. sterilization, aseptic processing, cleanliness zoning, effective bioburden/microbial control strategies/risk assessments, environmental monitoring program, microbiological testing programs for QC raw materials, intermediate products, drug substances and finished products) for Moderna’s products, produced at Moderna’s manufacturing facility and at affiliated contract organization facilities;
proactive surveillance of global and emerging regulatory requirements;
microbiological methods lifecycle management (development, validation, implementation, transfer, upgrade);
implementation of automation/digitalization and adoption of novel technologies;
complex investigations about microbiological deviations in manufacturing and/or in laboratory;
laboratory out of trend (OOT) and out of specification (OOS) investigations.

This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.

The individual will also act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory and Technical Development. This position may be based both in Moderna US and/or in Moderna International organizations.

**Here’s What You’ll Do**:
Ensure effective governance and strong policies/standards/procedures are established, implemented, audited, and continuously improved for the enterprise to ensure cGMP compliance with global regulations in the context of microbiological sterility assurance processes.

Facilitate harmonization/optimization of multi-site microbiological processes and systems (e.g. sterilization, aseptic processing, cleanliness zoning, effective bioburden/microbial control strategies/risk assessments, environmental monitoring program, microbiological testing of QC raw materials, intermediate products, drug substances and finished products, technology transfer and method validation, critical reagents program).

Perform proactive surveillance of global regulatory requirements (international and domestic), industry guidance and emerging trends of regulators to ensure Moderna policies and standards remain current and are benchmarked against best practices in the context of microbiology sterility assurance processes.

Collaborate for proactive identification of risk and compliance issues, manage prioritization of transformational and continuous improvement activities to ensure delivery of scientifically sound and efficient microbiological methods.

Provide input for the design of water systems and controlled environments and cleanliness control strategies.

Provide global oversight about validation of microbiological methods (including bioburden, endotoxin and sterility assays as well as microbial identifications as required) used to support Moderna’s in-process, release and stability testing programs internally and externally (CTOs/CMOs).

Provide technical support, in the context of microbiological processes:
for sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections);
to manufacturing and quality during manufacturing and/or laboratory deviation investigations, change control and CAPAs.

Work closely with QC Labs, Digital/IT and Analytical Development to implement automation and introduce novel approaches/technologies to improve overall microbiological method performance and throughput.

Work with Digital/IT to continually strengthen data integrity across microbiological laboratories world-wide.

Support CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and HA information requests and communications and ensure robust analytical control strategy and holistic data package for supporting regulatory filings.

Support Annual Product Quality Review (APQR) activities.

Participates in Specification Review Committee in establishing and revising microbiological specifications for Moderna’s products to ensure global consistency and alignment.

**Here’s What You’ll Bring to the Table**:
Bachelor’s degree with a minimum of 10 years of experience in the biotechnology or pharmaceutical industries, with 5+ years’ experience leading Quality Control/Microbiological Labs in a cGMP organization, with focus in Microbiology. Advanced degree preferred.

Deep understan