Sr. Manager, Quality Assurance Operations, New
vor 1 Woche
**The Role**:
Reporting to the Associate Director of Quality Assurance Operations DP for the International Organization, the Senior Manager QA Operations NPI will be responsible for providing QA oversight for implementation of new sites/ equipment in Moderna Facilities and QA oversight for qualification and process validation end to end and to ensure compliance with internal policies and procedures and specifications, regulatory requirements.
The Senior Manager QA Operations will support Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The incumbent will provide QA support for drug substance or drug product activities. Will oversee of drug substance or drug product sites and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.
**Here’s What You’ll Do**:
Provide Quality support to the new sites projects in close collaboration with Global Engineering and local teams.
Review and approve design, master plan and risk assessments.
Review and approve policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.
Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
Support quality investigations and manage CAPA (corrective and preventative actions).
Review and coordinate approval of all changes made to the manufacturing, testing and control processes.
Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.
Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.
Manage End to End New Product Introduction by building network between Drug Substance and Drug Product platforms and coordinate Regulatory commitments responses with Regulatory CMC stakeholders.
Coordinate transversally alignment between Drug substances sites (internally or CMOs) or Drug Products sites (internally or CMOs).
This role requires approximately 40% international travel.
**Here’s What You’ll Bring to the Table**:
Minimum education requirement is a Bachelor’s degree, preferably in Sciences or Engineering or Pharmacy
Industry Experience of 8+ Years
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
Signification experience in qualification/validation.
Ability to interact effectively with all levels of personnel within the organization.
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
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).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A digital first and curious mindset that allows you to constantly learn and challenge the status quo.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas includ
-
Quality Assurance Manage
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group AG VollzeitQuality Assurance ManagerYou will support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel, take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products are...
-
Quality Assurance Manager
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group AG VollzeitQuality Assurance ManagerAls Quality Assurance Manager bei Basel Drug Substance trägt man zu einer adäquaten Quality Oversight über die vier Value Streams bei.Start date: ASAPLatest start date: End date: Man unterstützt oder übernimmt Aufgaben und Projekte in einem der drei Quality Operations Chapter (MAB, SUT, ADC&SM). Als Quality Assurance Manager...
-
Quality Assurance
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Lonza AG VollzeitSwitzerland, BaselQuality Assurance Manager (Supply Chain Compliance Manager)Location: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, 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...
-
Quality Assurance
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Lonza AG VollzeitSwitzerland, BaselQuality Assurance Manager (Supply Chain Compliance Manager)Location: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, 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...
-
Quality Assurance
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitSwitzerland, BaselQuality Assurance Manager (Supply Chain Compliance Manager)Location: Basle/SwitzerlandFixed Term Contract - End Date December 2025Today, 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...
-
Quality Assurance Manager
vor 2 Wochen
Basel, Schweiz Genedata VollzeitGenedata transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic,...
-
Quality Assurance Manage
vor 2 Monaten
Basel, Schweiz Coopers Group AG Vollzeit**Quality Assurance Manager** You will support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel, take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products...
-
Quality Assurance Manage
vor 1 Tag
Basel, Schweiz Coopers Group AG Vollzeit**Quality Assurance Manager** You will support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel, take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products...
-
Quality Assurance
vor 2 Monaten
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager (Supply Chain Compliance Manager)** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, 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...
-
Quality Assurance
vor 1 Tag
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager (Supply Chain Compliance Manager)** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, 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...
-
Quality Assurance Manager
Vor 6 Tagen
Basel, Schweiz Coopers Group AG VollzeitQuality Assurance Manager Als Quality Assurance Manager bei Basel Drug Substance trägt man zu einer adäquaten Quality Oversight über die vier Value Streams bei. Start date: ASAP Latest start date: 1.08.2024 End date: 30.06.2025 Man unterstützt oder übernimmt Aufgaben und Projekte in einem der drei Quality Operations Chapter (MAB, SUT, ADC&SM). Als...
-
Quality Assurance Manager
vor 4 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...
-
Manager, Quality Assurance
vor 2 Wochen
Basel, Schweiz Moderna VollzeitThe 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,...
-
Global Distribution Quality Manager
vor 2 Monaten
Basel, Schweiz Coopers Group AG VollzeitGlobal 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,...
-
Global Distribution Quality Manager
vor 9 Stunden
Basel, Schweiz Coopers Group AG VollzeitGlobal 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,...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, 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,...
-
Quality Assurance Manager
vor 1 Tag
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, 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,...
-
Quality Assurance Manager
vor 1 Woche
Basel, Schweiz Panda Vollzeit**Quality Manager (f/m/d) 100%** A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Lonza AG VollzeitSwitzerland, BaselQuality Assurance ManagerLocation: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, 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...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Lonza AG VollzeitSwitzerland, BaselQuality Assurance ManagerLocation: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, 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...
