Aktuelle Jobs im Zusammenhang mit Manager, Global Quality Control, Sterility Assurance - Basel - Moderna Therapeutics

  • Sterility Assurance Expert

    vor 1 Tag

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **How you will contribute**: - Lead investigations linked to microbiological deviations and actively lead subsequent corrective actions, where necessary. - Be responsible for risk analyses defining environmental and utility monitoring strategies. - Carry out Sterility Assurance assessments of all changes related to his/her associated production area. - Lead...

  • Quality Assurance Manager

    vor 2 Wochen

    Basel, Schweiz Global Kader Personal Vollzeit

    **EINFÜHRUNG**: Als Preferred Supplier für Roche Basel in suchen wir eine engagierte Persönlichkeit als **Quality Assurance Manager**: (Vertragstyp 3 Monate mit Möglichkeit auf Verlängerung) mit Startdatum so rasch wie möglich oder innerhalb von zwei Monaten. Remote/Home Office: hybrid, gemäss gesetzlichen Vorgaben, on site wird...

  • Quality Assurance Manager

    Vor 5 Tagen

    Basel, Schweiz ITech Consult Vollzeit

    **Quality Assurance Manager (M/F/d) - cGMP / Quality requirements / analytical working / CAPA/ OOS / deviation management / English/ German** **Project**: For our customer a big pharmaceutical company in Basel we are looking Quality Assurance Manager (M/F/d). **Background**: As within Quality Assurance for Quality Control Basel/Kaiseraugst you are ensuring...

  • Quality Assurance Manager

    Vor 3 Tagen

    Basel, Schweiz Flex Vollzeit

    Flex, a Fortune global 500 company, is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that...

  • Global Distribution Quality Manager

    vor 2 Wochen

    Basel, Schweiz Coopers Group AG Vollzeit

    Global Distribution Quality Manager Join our client's team at a leading pharmaceutical company, as a **Global Quality Manager in Distribution Quality (d/f/m)**. In this role, you will play a crucial part in ensuring high-quality standards throughout the global supply chain and distribution operations. If you have a background in life sciences, pharmacy,...

  • Head of Quality Control Operations

    Vor 7 Tagen

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **Job Title**:Head of Quality Control Operations **Location**: Neuchâtel **About** the **role**: Directs the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support and Quality Sterility Assurance) in a large size plant and directs a large department to support Facility, Division and Corporate wide initiatives. Responsible for performances...

  • Global Quality Manager Distribution Quality

    vor 2 Wochen

    Basel, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Global Quality Manager Distribution Quality** for a temporary contract of 12 months with a possible extension. **Tasks**: - Manage GDP non-conformities or logistics related events (e.g. Temperature Monitoring issue,...

  • Global Quality Manager Distribution Quality

    vor 2 Wochen

    Basel, Schweiz GITR Vollzeit

    **INTRODUCTION**: As a preferred supplier for Roche Basel, we are looking for an individual as **Global Quality Manager Distribution Quality**: - (contract for 12 Months, with possible extension). The start date is asap or within 2 months. Remote/Home Office: on-site required 3 of 5 days a week. **ASSIGNMENT DESCRIPTION**: - Manage GDP non-conformities or...

  • Quality Assurance Manager

    Vor 3 Tagen

    Basel, Schweiz Panda International Vollzeit

    Senior Quality Assurance Manager Biotechnology 80 - 100% Our client is a leading biotechnology scale-up that is experiencing significant growth and is actively seeking to expand their Quality Assurance division with a permanent position in their department. They are at the forefront of scientific innovation and are dedicated to developing groundbreaking...

  • Quality Assurance Manager

    vor 1 Woche

    Basel, Schweiz ITech Consult AG Vollzeit

    **Project**: For our client, a large pharmaceutical company based in Basel, we are looking for a Quality Assurance Manager (M/F/d). **Background**: The Basel Drug Substance division at the Group headquarters in Basel is divided into various production units for monoclonal antibodies (MAB), single-use technology (SUT), and antibody drug conjugates (ADC)....

Manager, Global Quality Control, Sterility Assurance

vor 2 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Associate Director, Global Sterility Assurance, the Manager, 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 support about the main following topics (not exhaustive):
sterility assurance 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;
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 continuous support in setting policies/standards/procedures and support related implementation

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).

Providing input in the design of manufacturing processes, controlled environments, and packaging from a microbiological standpoint: Conduct risk assessments, as needed, to ensure compliance.

Act as sterility assurance contamination control SME

Assure the harmonization of low bioburden policy and strategy.

Establish and maintain the company contamination control strategies and related documents.

Perform all investigations related to microbial control for facility and DS/DP products (endotoxin / bioburden)

Own gowning, cleaning, wipe down processes working collaboratively with MFG to reset baseline.

Facilitate and drive the EAT

Draft and summarize the facility trend reports.

Build out team to incorporate specialists with required skills to advance program: Trending, MFG process knowledge, MODA report overhaul.

Take ownership of gowning qualifications and program.

Generate technical reports, as required, to support business needs to include product impact statements where microbial control is challenged.

Draft and establish and maintain VAL-RA documents for EM Site selection

Function as central services for facility in terms of contamination control.

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

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 5-7 years of experience in the biotechnology or pharmaceutical industries, with 3+ years’ experience leading Quality Control/Microbiological Labs 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.

Good knowledge and expertise in microbiological analytical method lifecycle management.

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

Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).

Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferre