Director, Product Quality Lead

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

The Role:


Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle.

Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks. Ensures quality management of products and processes lifecycle, leading improvement, and alignment with current regulatory expectations.

Here's What You'll Do:

Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Moderna's vaccines and therapeutics inclusive of combination product design controls

Interface in a matrix environment with drug and combination product design and development teams to develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical transfer and Control Strategy

Ensure significant Quality risks are escalated and mitigated in a timely manner

Provide quality support for significant changes and issue management (Deviations/CAPAs) across Moderna's internal and external manufacturing and testing sites

Contribute to improvement and harmonization initiatives across Global Quality Operations in line with current Regulatory expectations.

In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement of new and emerging technologies to ensure quality and compliance frameworks are established

In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes

Here's What You'll Bring to the Table:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 15-20 years; 10-15 with MS.

Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.

Knowledge in design controls, risk management, and quality system requirements.

Working knowledge of control charts and statistics applied to process validation and data trending using statistical programs and software (e.g, JMP, Looker, Statistica, Spotfire)

Experience in computerized systems, automation, manufacturing, and testing within biotechnology industry is a plus.

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 including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

LI-TR1

  • Quality Director

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Thermo Fisher Scientific Vollzeit

    The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...

  • Product Quality Lead

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Company Description At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.**The Product Quality Lead provides cross-functional...

  • Director Digital Quality

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Panda International Vollzeit

    Director Digital Quality:Location Basel, SwitzerlandBusiness Sector BiotechnologyJob ref 22276Published- about 5 hours agoDirector Digital QualityAre you a professional with expertise in digital quality management within the Pharmaceutical and Biotechnology manufacturing industry? Join a top-tier organization in Northern Switzerland, celebrated for its...

  • Product Quality Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    About the role:As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External inspections...

  • Associate Director Quality Assurance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ACADIA Pharmaceuticals Inc. Vollzeit

    Associate Director Quality Assurance - GmbHOn behalf of Acadia GmbH the Associate Director, GMP Quality Operations at Acadia GmbH will be responsible for oversight of cGMP European operations within a global Quality Assurance department of Acadia Pharmaceuticals Inc. Responsibilities will include oversight of assigned cGMP operations performed at Contract...

  • Associate Director, Distribution Quality

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description:_The position will report to the Senior Director, Distribution Quality, will provide GDP/GSP expertise and manage day to day operations for distribution of IMPs and commercial products globally for BeiGene. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory...

  • Associate Director, Global Quality Control, Change

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:Reporting to the Sr.Director of Global Quality Control Standards and Policies, the Associate Director, 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...

  • Director, External Quality Control

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:Moderna is seeking an AD/D External Quality Control based in Basal, Switzerland to oversee Quality Control (QC) testing including in-process, release, and stability in support of contract manufacturing and testing facilities and overall international operations for Moderna clinical and commercial products. This position reports to the Head Quality,...

  • Technical Project Leader Drug Product

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Technical Project Leader - Drug Product (5175 ADA)Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Technical Project Leader Drug Product to join their late-stage development and commercial oral dosage forms and lead the drug product development of various oral...

  • Director of Quality Assurance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Warman O'Brien Vollzeit

    QA Director Basel, Switzerland Start Date: ASAP (permanent position) Up to CHF 180kA global, innovative biopharmaceutical company are searching for a driven QA GMP expert to provide vital strategic input across all EU affiliate sites. Within this role you will be responsible for ensuring the highest Quality and Regulatory standards (GMP, GDP, PV) are...

  • Associate Director Quality Assurance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. Vollzeit

    Primary Responsibilities:Provide support to QP activities as needed to ensure timely market release of Acadia product as required.Oversee CMO's from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.Participates in design, implementation and management of the Acadia GMP quality management system, based on EMA/MHRA...

  • Quality Control Lead Investigator

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Modis Vollzeit

    For a leader in the pharmaceutical industry, opportunity of minimum 15 months as Quality Control Lead Investigator.Your Role: Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis. Enable and Support team of the Quality Control (QC) department responsible for testing raw materials, drug substance (API), drug...

  • Lead Product Related Special Situations Management

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Philip Morris International Vollzeit

    Lead Product Related Special Situations Management (PRSSM) - Neuchâtel, SwitzerlandBe a part of a revolutionary change.At PMI, we've chosen to do something incredible. We're totally transforming our business, and building our future on smoke-free products.With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream...

  • Director Quality Operations

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz J. Wagner GmbH Vollzeit

    WAGNER - Powered by TalentsMit weltweit mehr als 2.000 Mitarbeitenden an 19 Standorten sind wir einer der marktführenden Hersteller innovativer Beschichtungstechnik. Heimwerker, Handwerker und Industriekunden auf der ganzen Welt vertrauen auf unsere innovativen Produkte, die Ressourcen schonenden Technologien und unseren persönlichen, schnellen Service....

  • Director, Global Quality Control, Sterility

    Vor 7 Tagen

    Basel, Basel-Stadt, 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...

  • Director, Drug Product, International Ms&t

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The RoleThis role in the Manufacturing Science and Technology (MST) department will support Moderna's International Drug Product manufacturing supply network. Based in Basel, this role will be to lead the international drug product MST function to support technology transfer, validation, continued process verification, investigations and change management....

  • Director Regulatory Affairs, Quality Assurance and

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description:Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...

  • Director, Project Initiation Lead

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    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, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Associate Director Data Products and Solutions

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Group Ltd. Vollzeit

    Associate Director Data Products and Solutions (f/m/d) page is loaded Associate Director Data Products and Solutions (f/m/d) Apply locations CH - Basel time type Full time posted on Posted Yesterday job requisition id R60837 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula...

  • Associate Director, Quality Standards and Policies

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:Reporting to the Director of Quality Management Systems, the Quality Standards and Policies Associate Director is responsible for enabling quality and compliance excellence by interpreting regulatory intelligence to support translation into the necessary Quality Standards.Working in collaboration with key stakeholders in Quality and across CMC, to...