Manager of Quality Operations in Manufacturing

2 weeks ago


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

Quality Assurance Manufacturing Lead

Company: Tucker Parker Smith Group (TPS Group)

Role Overview: This position is pivotal in overseeing the Quality Department, ensuring stringent compliance with the company's Quality Systems.

Key Responsibilities:

  • Administer and uphold Quality Systems, including Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management.
  • Support inspection readiness and assist during regulatory audits and internal assessments.
  • Analyze quality system metrics and trends to foster continuous improvement efforts.
  • Engage collaboratively with Technical Operations and other divisions to ensure consistency in quality system execution.
  • Lead projects aimed at enhancing quality systems and mapping processes.
  • Create and sustain site-specific Quality Technical Agreements.

Qualifications:

  • Bachelor's or Master's degree in life sciences or a related discipline.
  • Over 6 years of experience in the pharmaceutical or a related sector.
  • Comprehensive knowledge of cGMPs, Health Authority Regulations, and Quality Systems.
  • Technical expertise in manufacturing processes and capability to analyze analytical data.
  • Awareness of FDA, EMA, and global regulatory standards.


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

    Quality Assurance ManagerCompany: Tucker Parker Smith Group (TPS Group)Role Overview: The Quality Assurance Manager will be instrumental in overseeing the Quality Department, ensuring effective management of the organization’s Quality Systems.Key Responsibilities:Administer and ensure compliance with Quality Systems, which encompass Documentation,...


  • Novato, California, United States Compass Consulting Full time

    About Us: Compass Consulting is dedicated to advancing healthcare solutions through innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders.Position Overview:This role, reporting to the Quality Assurance Supervisor/Manager/Senior Manager, is pivotal in ensuring quality compliance across various processes involved in...


  • Novato, California, United States Randstad Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Operations Specialist to join our team at Randstad. As a Quality Assurance Operations Specialist, you will be responsible for providing quality oversight of operations, including reviewing GMP documentation, scanning and archiving production batch records, and ensuring manufacturing adherence to...


  • Novato, California, United States BioMarin Pharmaceutical Inc. 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 quality...


  • Novato, California, United States Talent Software Services Full time

    Job SummaryTalent Software Services is seeking a Quality Assurance Operations Specialist for a contract position. The opportunity will be four months with a strong chance for a long-term extension.Key ResponsibilitiesReview of Good Manufacturing Practice (GMP) documentation from manufacturing, including logbooks, production batch records, and electronic...


  • Novato, California, United States Talent Software Services Full time

    Job SummaryTalent Software Services is seeking a Quality Assurance Operations Associate for a contract position. The opportunity will be four months with a strong chance for a long-term extension.Key ResponsibilitiesReview of Good Manufacturing Practice (GMP) documentation from manufacturing, including logbooks, production batch records, and electronic...


  • Novato, California, United States Randstad Life Sciences US Full time

    At Randstad Life Sciences US, we pride ourselves on being a dynamic and collaborative organization where our team members are versatile, empowered, and encouraged to take initiative.We seek individuals who possess a high degree of energy, motivation, and organizational skills, as well as the ability to inspire and lead others.The Technical Operations...


  • Novato, California, United States Biomarin Full time

    About UsAt BioMarin, our Technical Operations team is dedicated to the development and production of our innovative therapies for clinical trials and commercial distribution. Our skilled engineers, technicians, scientists, and support personnel are committed to establishing and maintaining BioMarin's advanced manufacturing processes and facilities. They...


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

    Job SummaryHarvest Technical Services, Inc. is seeking a highly skilled Operations Quality Assurance Specialist to join our team. As a key member of our operations department, you will be responsible for providing quality oversight of various aspects of our operations.Key Responsibilities:Review and verify GMP documentation from manufacturing, including...


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

    Job SummaryHarvest Technical Services, Inc. is seeking a highly skilled Operations Quality Assurance Specialist to join our team. As a key member of our operations department, you will be responsible for providing quality oversight of various aspects of our operations.Key ResponsibilitiesQuality Oversight: Review and ensure adherence to company policies,...


  • Novato, California, United States BioMarin Pharmaceutical Inc. 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 quality...


  • Novato, California, United States Harvest Technical Services Full time

    Company OverviewHarvest Technical Services is a leading organization dedicated to developing innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders. Our focus is on conditions that currently lack effective treatment options, often impacting small patient populations, including children.Role SummaryThe Quality Systems...


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

    Job OverviewCompany Overview: Harvest Technical Services, Inc. is a pioneering organization dedicated to providing innovative therapeutics for patients facing serious and life-threatening rare genetic disorders. Our focus is on conditions that currently lack effective treatment options, particularly those affecting children.Role Summary: The Quality...


  • Novato, California, United States BioMarin Pharmaceutical Inc. Full time

    Position Overview The Quality Control Analyst plays a crucial role in ensuring the integrity and compliance of our operations at BioMarin Pharmaceutical Inc. This position involves a comprehensive approach to quality management within the manufacturing environment. Key Responsibilities Quality Oversight: Conduct direct observations of manufacturing...


  • Novato, California, United States BioSpace, Inc. Full time

    Job SummaryBioSpace, Inc. is seeking a highly skilled Senior Quality Associate to join our team in the Technical Operations group. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.Key Responsibilities:Provide on-the-floor quality assurance...


  • Novato, California, United States TalentBurst Full time

    Position: Technical Manager, Quality Systems Company Overview TalentBurst is a leader in providing innovative solutions for patients facing serious and rare genetic conditions. Our mission is to develop effective therapies for diseases that currently have limited treatment options, focusing on improving the lives of those affected, especially children. Role...


  • Novato, California, United States BioMarin Full time

    **About BioMarin**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, California, United States TalentBurst, an Inc 5000 company Full time

    Quality Assurance Systems ManagerCompany: TalentBurst, an Inc 5000 companyRole OverviewThe Quality Assurance Systems Manager plays a crucial role in overseeing the adherence to quality management systems within the organization. This position is pivotal in ensuring that all quality-related processes, including Documentation, Deviation Management, CAPA,...


  • Novato, California, United States TalentBurst Full time

    Position: Technical Manager, Quality Systems Overview TalentBurst is a leader in the development of innovative therapies aimed at addressing serious and life-threatening rare genetic disorders. Our mission is to target conditions that currently lack effective treatment options, impacting small patient populations, including children. We are committed to...


  • Novato, California, United States Innova Solutions Full time

    Innova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team.Job Summary:We are looking for a detail-oriented and organized individual to provide quality oversight of our operations. As a Quality Assurance Specialist, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and...