Quality Technical Manager
4 weeks ago
Description
Client's is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any treatment options.
Client's will continue to focus on advancing therapies that are the first or best of their kind.
Client's
Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These engineers, technicians, scientists and support staff build and maintain client's
cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Come to join our team and make a meaningful impact on patients' lives.
Summary Description
The Quality Systems Technical Manager is responsible for ensuring client's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.
Responsibilities:
Participate in inspection readiness, regulatory inspection support and self- inspection activities.
Quality system metrics and trending.
Works cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.
Participate in quality system improvement and process mapping initiatives.
Author and own site Quality Technical Agreements.
Education:
BS/MS
preferably in the life sciences
Experience:
6+ years experience in pharmaceutical or related industry.
Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.
Familiarity with FDA, European and international regulatory requirements.
#J-18808-Ljbffr
-
Quality Technical Manager
1 month ago
Novato, United States R&D Partners Full timeJob DescriptionJob DescriptionBiotechnology company is hiring a Quality Technical Manager to ensure the company's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed. ResponsibilitiesParticipate in inspection readiness, regulatory inspection support and...
-
3633 Technical Manager, Clinical QA
16 hours ago
Novato, United States Harvest Technical Services Full timeJob Description Job Description Hybrid role - 3 days a week onsite Job Description: Create, revise and approve the companys Phase Appropriate Quality Systems documentation. Represent Clinical Quality Department in cross functions forums. Draft and approval of Quality Technical Agreements with CDMOs as required for internal support. Provide quality oversight...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
Senior Technical Manager, Quality Compliance
21 hours ago
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
Novato, United States BioMarin Pharmaceutical Full timeDescription Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance...
-
Novato, United States Biomarin Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
3633 Technical Manager, Clinical QA
1 month ago
Novato, United States Harvest Technical Services, Inc. Full timeJob DescriptionJob DescriptionHybrid role - 3 days a week onsiteJob Description:Create, revise and approve the companys Phase Appropriate Quality Systems documentation.Represent Clinical Quality Department in cross functions forums.Draft and approval of Quality Technical Agreements with CDMOs as required for internal support.Provide quality oversight for...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeThe Senior Technical Manager, Supplier Quality Management (SQM) will be responsible for owning and ensuring the quality and compliance of a category of supplier's within BioMarin's global supplier network. Emphasis will be on Single Use Technologies (SUTs) such as Filters, Bioprocess Containers, Reusable Tubing Assemblies, and some Consumables used in...
-
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeThe Senior Technical Manager, Supplier Quality Management (SQM) will be responsible for owning and ensuring the quality and compliance of a category of supplier's within BioMarin's global supplier network. Emphasis will be on Single Use Technologies (SUTs) such as Filters, Bioprocess Containers, Reusable Tubing Assemblies, and some Consumables used in...
-
3633 Technical Manager, Clinical QA HOLD
15 hours ago
Novato, United States Harvest Technical Services, Inc. Full timeJob DescriptionJob DescriptionHybrid role - 3 days a week onsiteJob Description:Create, revise and approve the companys Phase Appropriate Quality Systems documentation.Represent Clinical Quality Department in cross functions forums.Draft and approval of Quality Technical Agreements with CDMOs as required for internal support.Provide quality oversight for...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, United States BioMarin Pharmaceutical Full timeDescriptionWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Senior Technical Manager, Quality Compliance
18 hours ago
Novato, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, United States Biomarin Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Senior Technical Manager, Quality Compliance
1 week ago
Novato, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Senior Technical Manager, Quality Compliance
18 hours ago
Novato, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
3178 External Quality Associate I
22 hours ago
Novato, United States Harvest Technical Services, Inc. Full timeJob DescriptionJob DescriptionHybrid:Duties: We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.The Quality Associate 1 reports to the...
-
3178 External Quality Associate I
4 days ago
Novato, United States Harvest Technical Services, Inc. Full timeJob DescriptionJob DescriptionHybrid:Duties: We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.The Quality Associate 1 reports to the...
-
3178 External Quality Associate I
3 days ago
Novato, United States Harvest Technical Services, Inc. Full timeJob DescriptionJob DescriptionHybrid:Duties:We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.The Quality Associate 1 reports to the...