Associate Director Global Cmc Quality Operations
Vor 3 Tagen
**The Role**:
Reporting to the Director, Product Quality Lead the Associate Director, Product Quality Lead will be responsible for developing, approving, monitoring and maintaining critical quality standards, identifying quality risks, ensuring quality management of product and processes lifecycle, leading improvement and alignment with current regulatory expectations.
The individual will ensure robust processes are implemented across Moderna’s global operations for management of product and process lifecycle quality (control strategy, technology transfer and changes, process validation lifecycle, (quality monitoring). The individual will partner cross-functionally with Supply Chain, Manufacturing Sciences & Technology, Manufacturing, Digital and Regulatory as the Quality representative. This role will entail representation at the change review board(s) to operationalize strategic projects including product launch in support of Moderna’s CMC programs.
**Here’s What You’ll Do**:
Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Moderna’s vaccines and therapeutics
Develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical Transfer and Control Strategy, in collaboration with Technical Development (TD), Manufacturing Sciences & Technology (MST), Regulatory Affairs (RA), Quality Control (QC), Quality Assurance (QA), Manufacturing (MFG) and Facilities and Engineering (F&E).
Ensure significant Quality risks are escalated and mitigated in a timely manner
Coordinate APQR process execution within network of internal, external and international partners to ensure appropriate documentation are delivered 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 the quality systems business process owners and site quality operations team, 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’s degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years; 8-10 with MS.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.
Practical experience with Quality Risk Management lifecycle.
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 winter break
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.
-
Associate Director, Global Regulatory Science
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...
-
Associate Director, Cmc Regulatory Affairs
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...
-
Associate Director, Product Quality Lead
vor 7 Monaten
Basel, Schweiz Moderna Therapeutics VollzeitThe Role Critical Raw Material (CRM) play an essential role for our Product Quality impacting across all our programs. Reporting to the Sr Director - Product Quality, the A/Director - Product Quality Lead (PQL) will be responsible for providing end-to-end quality oversight to our critical raw material. Develop, approve, monitor, and maintain critical...
-
Associate Director, Product Quality Lead, Quality
vor 4 Monaten
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,...
-
Associate Director Regulatory Affairs Biosimilars
vor 6 Monaten
Basel, Schweiz Abbott Laboratories Vollzeit**Abbott **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...
-
Business Analytics Associate Director
vor 6 Monaten
Basel, Schweiz Novartis Vollzeit390892BR **Business Analytics Associate Director**: Switzerland **About the role** Location: Basel, Switzerland (Hybrid) **About this role**: Our **Business Analytics Associate Director** manages metrics for 400+ trials, provides analytics as a service, and advance automation and data science tools to enable data driven decision making to reduce clinical...
-
Associate Director Quality Assurance and Compliance
vor 2 Monaten
Basel, Schweiz Veristat VollzeitJob Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...
-
Associate Director, Microbiology
vor 4 Monaten
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,...
-
Basel, Schweiz Abbott Laboratories VollzeitAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
Associate Director Regulatory Affairs Biosimilars
vor 4 Wochen
Basel, Schweiz Abbott VollzeitJOB DESCRIPTION:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...
-
Associate Director Quality Assurance and compliance
vor 2 Monaten
Basel, Schweiz Veristat VollzeitJob Description : Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures...
-
Associate Director Global Scientific Affairs
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.** **Associate Director...
-
Associate Director, Sterility Assurance
vor 11 Stunden
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...
-
Basel, Schweiz Abbott VollzeitAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...
-
Associate Director Global Program Mgnt
vor 7 Monaten
Basel, Schweiz Novartis Vollzeit391607BR **Associate Director Global Program Mgnt**: Switzerland **About the role** The key accountabilities for the Associate Director, Global Program Management, Oncology are as follows: - Lead project teams with respect to the timing, scenario/options development, risk management, opportunities / challenges, and requirements of interfacing with...
-
Associate Director, Supply Chain
vor 7 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description:_ Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the contract manufacturers (CMO) and the functions within the company to meet contract's deliverables, provide services, and keep the relationship positive & on track and deliver performance goals. He/she will also work...
-
Head of Cmc/cmc-qa
vor 2 Monaten
Basel, Schweiz Ridgeline Discovery GmbH VollzeitGRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO’s differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic...
-
Associate Director, R&d Quality Systems, Strategy
vor 2 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description: The Associate Director of R&D Quality Systems, Strategy, and Excellence (International & Affiliate) plays a pivotal role in ensuring the consistent implementation and alignment of global quality policies, procedures, and GxP standards at the local and regional levels. This global position is responsible for supporting local affiliates...
-
Associate Director Global Scientific Affairs
vor 10 Stunden
Basel, Schweiz Cabinet de recrutement Sparkk VollzeitWe are looking for an Associate **Director Global Scientific Affairs** for one of our clients, an international pharmaceutical company active in the fields of hematology and immunology. **Responsibilities**: - Develop and lead the scientific communications strategy - Lead the global publication plan in alignment with global medical and scientific affairs...
-
Quality & Regulatory Associate, Challenging Global
vor 6 Monaten
Basel, Schweiz Stratpharma VollzeitAn ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company’s global QA and RA functions. This is a highly successful company who have an impressive 200% year on year growth and are going through...
