Quality Technical Manager

3 weeks ago


Novato, United States Intelliswift Software Inc Full time

Technical Manager, Quality Systems

Description

*** 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. *** will continue to focus on advancing therapies that are the first or best of their kind.

***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 ***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 ***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



  • Novato, United States Intelliswift Full time

    Quality Technical Manager Job ID: 24-01475 Technical Manager, Quality Systems Description * 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...


  • Novato, United States Talent Software Services, Inc. Full time

    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...


  • Novato, United States R&D Partners Full time

    Job 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...


  • Novato, United States Tucker Parker Smith Group Full time

    Quality Systems Technical Manager Location: Novato, CA 9-month assignment (potential to extend) Pay Rate: $50-60/hour Our leading pharmaceutical client is looking for a global leader in developing therapeutics for patients with serious and life-threatening rare genetic diseases. Summary Description: The Quality Systems Technical Manager plays a vital role in...


  • Novato, United States Harvest Technical Services Full time

    Hybrid role - 3 days a week onsiteJob Description:Create, revise and approve the company's 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 internally manufactured...


  • Novato, United States Harvest Technical Services, Inc. Full time

    Job 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...


  • Novato, United States Talent Software Services Full time

    Technical Manager, Clinical QANovato, CA6 monthsJob Responsibility: Create revise and approve BioMarin 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 internally...


  • Novato, United States Talent Software Services Full time

    Technical Manager, Clinical QA Novato, CA 6 months Job Responsibility: Create revise and approve BioMarin 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 internally...


  • Novato, United States Intelliswift Full time

    Job ID: 24-01474 Hybrid role - 3 days a week onsite Create revise and approve *** 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 internally manufactured early-stage...


  • Novato, United States Talent Software Services Full time

    Technical Manager, Clinical QA Novato, CA 6 months Job Responsibility: Create revise and approve BioMarin 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 internally...


  • Novato, United States Intelliswift Software Inc Full time

    Hybrid role - 3 days a week onsite Create revise and approve *** 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 internally manufactured early-stage products and starting...


  • Novato, United States BioMarin Full time

    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 and...


  • Novato, United States Tucker Parker Smith Group (TPS Group) Full time

    QC Analyst Location: Novato, CA. (On-Site) 12-month assignment (potential to extend or convert) Pay Rate: $28/hr. Schedule: Morning Shift Our pharmaceutical industry client, a global leader in therapeutics for rare and life-threatening genetic diseases, is looking for a QC Analyst that will primarily focus on the centralized program management of reference...


  • Novato, United States Tucker Parker Smith Group (TPS Group) Full time

    QC Analyst Location: Novato, CA. (On-Site) 12-month assignment (potential to extend or convert) Pay Rate: $28/hr. Schedule: Morning Shift Our pharmaceutical industry client, a global leader in therapeutics for rare and life-threatening genetic diseases, is looking for a QC Analyst that will primarily focus on the centralized program management of reference...


  • Novato, United States Tucker Parker Smith Group (TPS Group) Full time

    QC Analyst Location: Novato, CA. (On-Site) 12-month assignment (potential to extend or convert) Pay Rate: $28/hr. Schedule: Morning Shift Our pharmaceutical industry client, a global leader in therapeutics for rare and life-threatening genetic diseases, is looking for a QC Analyst that will primarily focus on the centralized program management of reference...

  • QC Analyst

    1 week ago


    Novato, United States Harvest Technical Services, Inc. Full time

    Job DescriptionJob DescriptionSummary:The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical...

  • QC Analyst

    1 week ago


    Novato, United States Harvest Technical Services, Inc. Full time

    Job DescriptionJob DescriptionSummary:The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical...


  • Novato, United States Harvest Technical Services, Inc. Full time

    Job DescriptionJob DescriptionSummary:The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical...


  • Novato, United States Vaco Full time

    As IT Support Specialist, you will be working with world class engineering andproduction operations teams to maintain a stable environment. You'll deploy andadminister systems and tools and provide front-line support to various sites anddepartments. You'll work closely with developers in supporting new services andtackle issues as they arise. This is an...


  • Novato, United States Vaco Full time

    As IT Support Specialist, you will be working with world class engineering andproduction operations teams to maintain a stable environment. You'll deploy andadminister systems and tools and provide front-line support to various sites anddepartments. You'll work closely with developers in supporting new services andtackle issues as they arise. This is an...