Director, Global Quality Control, Sterility

vor 7 Monaten

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Senior Director, Global Sterility Assurance, the Director, Global Sterility Assurance, will be providing technical and compliance leadership, collaborating closely with Moderna’s network of DS/DP manufacturing sites, microbiological laboratories, both internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), providing leadership regarding the following topics (not exhaustive):
sterility assurance and contamination control 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, critical utilities, 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 facilities and at affiliated contract organization facilities globally;
innovation and implementation of scientifically supported novel approaches tailored to the mRNA platform;
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 a global, interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Engineering, Regulatory and Technical Development. This position has global responsibility and may be based both in Moderna US and/or in Moderna International organizations.

**Here’s What You’ll Do**:
Provide support to the sterile manufacturing site on all aspects of aseptic processing/behaviors and sterility assurance and contamination control.

Provide advice/guidance and training for personnel to enhance aseptic practices and sterile production processes including the development and or review of training materials and curriculum.

Ensure alignment within Moderna’s network with the global microbiological/aseptic standards and compendial requirements.

Support inspections, partner audits etc. on-site and incorporate any lessons learned into Moderna’s sterility assurance 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 sterility assurance processes.

Execute a holistic end to end program utilizing QBD and contamination control risk assessments to evaluate and certify Moderna’s sterile manufacturing clinical drug product site in aseptic processing and to assure the sterility of Moderna’s products.

Provide input for the design of new Drug product facilities/lines to ensure cleanliness control and adequate aseptic manufacturing strategies.

Perform regular GEMBA style assessments of aseptic and low bioburden manufacturing operations, assessing compliance of operations including identification of deficiencies and opportunities for improvement

Facilitate harmonization/optimization of multi-site microbiological control 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).

Participate 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 15 years of experience in the biotechnology or pharmaceutical industries, with 7 - 10 years’ experience in QA/QC leadership in a cGMP organization, with focus in Microbiology. Advanced degree preferred.

Deep understanding and experience with EU and US regulations and ICH guidelines and regulations.

Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority.

Expertise in design, qualification and control of clean facilities and critical utilities.

Experience in data analysis and statistical evaluation and trending of microbiological data.

Experience in sterility assurance validation (terminal, aseptic, and/or reprocessing) and environmental controls for pharmaceutical manufacturing facilities.

Competency in multiple industrial terminal

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