Manager, Global Qc, Sterility Assurance

Vor 5 Tagen

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

  • Associate Director, Sterility Assurance

    Vor 3 Tagen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **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...

  • Head of Sterility Assurance

    vor 7 Monaten

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: The Head of Sterility Assurance oversee all aspects of sterility assurance across Takeda Neuchâtel site including Monitoring Controls, Environmental Monitoring, and Utilities as well validation controls for facilities, equipment, and utilities. He/She leads the Sterility Assurance organization towards excellent and efficient processes...

  • Sterility Assurance Expert

    vor 7 Monaten

    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...

  • Manager, Global Qc Change Controls

    Vor 5 Tagen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Sr. Director of Global Quality Control, the Manager, Global QC Change Controls (& Deviations), will be collaborating closely with Moderna’s network of QC Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), with the main following responsibilities...

  • Instrument Manager

    vor 7 Monaten

    Basel, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Qc Project Manager

    Vor 3 Tagen

    Basel, Schweiz Girardet Consulting AG Vollzeit

    Für unseren Kunden suchen wir zur Verstärkung des Teams einen QC Project Manager (m/w) für eine Festanstellung im Basler Raum zum nächst möglichen Termin. **Ihre Aufgaben**: - Mitarbeit in interdisziplinären Projektteams und Betreuung aller QC-Aspekte von der Akquise bis zur Markteinführung - Sicherstellen der Timelines und Bewahren des Überblicks...

  • QA / Qc Building Lead

    vor 7 Monaten

    Basel, Schweiz Quanta Vollzeit

    QA / QC Building Lead - Pharmacy - Stein, Switzerland - 3-Year contract We're representing a top-tier global pharmaceutical company situated in Stein. With significant capital investment and numerous ongoing projects, our client seeks a skilled Program HSE Director to strengthen their team. If you are local to Stein and are intrigued by this opportunity,...

  • Quality Assurance Manager for Consumables

    vor 1 Tag

    Basel, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as **Quality Assurance Manager for Consumables**: - (contract for 12 months, with possible extension). The earliest start date is as soon as possible or within your notice period. Remote/Home Office: hybrid, is possible but on site work is...

  • Global Pv Icsr Manage

    vor 7 Monaten

    Basel, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. **Role & Function** At Sobi,...

  • Manager, External Quality Control

    vor 7 Monaten

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **To be considered for this role, you must supply a CV / resume in English (as English is our internal business language) Additionally, this role will be working closely with our CMO partners who have locations in Europe (Italy) - therefore, trips to the sites are expected to be frequent (as we have a face-to-face / on-site ethos)** **The Role**: Reporting...

  • Quality Assurance Manager

    vor 7 Monaten

    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...

  • Quality Assurance Manager Qc

    vor 6 Monaten

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About** the **role**: An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 670 employees) for a Quality Manager, within the Quality Assurance Department. This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture...

  • QC Manager

    vor 1 Tag

    Basel, Schweiz Manpower SA Vollzeit

    Werden Sie Teil unseres Netzwerks und nutzen Sie unzählige Möglichkeiten!Die ManpowerGroup ist der weltweit führende Personaldienstleister. Mit unseren drei Marken - Manpower, Experis und Talent Solutions - unterstützen wir Unternehmen aus verschiedensten Branchen bei ihren Rekrutierungsbedürfnissen. Seit 75 Jahren sind wir in über 75 Ländern aktiv...

  • Quality Assurance Manager

    vor 2 Monaten

    Basel, Schweiz ITech Consult Vollzeit

    **Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified **Quality Assurance Manager (M/F/d).** **Background**: As part of the Quality Unit on-site, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team’s...

  • Qc Project Manager

    vor 7 Monaten

    Basel, Schweiz LHH Vollzeit

    **QC Project Manager** - Neuchâtel Missions: - Gestion de toutes les activités de transfert et de validation des méthodes analytiques. - Gestion de la coordination des protocoles et des rapports de transfert, validation des méthodes selon les besoins. - Coordonner la mise en place des données de base du contrôle qualité, y compris au sein du LIMS,...

  • Senior Quality Assurance Manager

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    As a Senior Quality Assurance Manager in our Global Technical Operations team, you will be responsible for driving the implementation of Annex 1 requirements at our Clinical Supply Centre in Basel.This role requires a strong understanding of quality assurance principles and experience in GMP-regulated environments. You will work closely with cross-functional...

  • Analytical Quality Assurance Manager

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled Analytical Quality Assurance Manager to join our team at Gi Group SA. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our analytical-pharmaceutical environment.Key Responsibilities:Review and approve SOPs, protocols, reports, Certificate of Analysis,...

  • Manager, Quality Assurance

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Manager, Global Stability Technical Writer

    vor 7 Monaten

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: In addition, the Global Stability Technical Writer will be responsible for supporting Global processes for harmonizing and integration of stability-related activities. Global Stability Technical Writer will also assist during HA Audits and will lead the governance of stability related processes and systems at Global level. **Here’s What...

  • Head of Quality Control Operations

    vor 6 Monaten

    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...