Manager Manufacturing Quality Operations, RTP, NC

2 weeks ago

Raleigh, United States GRAIL, LLC Full time
This position is a leader within the Quality Operations organization, responsible for establishing, implementing, maintaining, and improving the quality operations elements of GRAIL’s quality management system. This position interacts with departments throughout the organization including but not limited to Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking skills and good judgment to independently and proactively identify and solve broad, complex problems, effectively cascading functional strategy and decisions across teams and communicating status and recommendations to senior management. 
ResponsibilitiesLead medical device quality operations through interpretation, establishment, and execution of quality principles and concepts in accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, In Vitro Diagnostic Regulation, ISO 14971, 21 CFR 11, 21 CFR 820. Work on abstract problems across functional areas of the business.Identify and evaluate fundamental issues and resolutions for major functional areas through assessment of intangible variables.Interact with executive level management requiring negotiation to influence policy and decision-making.Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.Operate as a capable strategic people and thought leader.Acceptance Activities including incoming reagent material inspections, specimen collection kit inspections, and manufactured reagent DHR review and product release Support warehouse controls including identification and traceability Support facilities and equipment qualificationsSupport manufacturing process validations and QC test method validationsOn-market product DMR/MDF/RMF updatesEnsure high-quality execution of quality processes including NCRs, CAPAs, planned temporary deviations, and change management workflowsGenerate and analyze Quality Indices metrics and Quality Management Review metricsProvide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.Support the Quality, Regulatory, and Compliance functions ensuring a unified QA/RA/Compliance commitment to achieving established goals and objectives.Represent Quality Operations on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.
Preferred Qualifications:Bachelor’s or Master's degree in a related technical area, or MBA or equivalent8 + years of experience working within a medical device, pharmaceutical, or biotech regulated quality management system. Strong knowledge and implementation of applicable regulations and standards including but not limited to IVDR, 21 CFR 820, ISO 13485, ISO 14971, and 21 CFR 11.Proven leadership, organizational and management skills to coordinate cross-functional decision making.Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.Excellent written and verbal communication skills.Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements.Next Generation Sequencing (NGS) experience.Clinical laboratory QMS experience including ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH). ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.

  • Manager Manufacturing Quality Operations, RTP, NC

    3 weeks ago

    Raleigh-Durham, United States GRAIL Full time

    This position is a leader within the Quality Operations organization, responsible for establishing, implementing, maintaining, and improving the quality operations elements of GRAIL's quality management system. This position interacts with departments throughout the organization including but not limited to Quality, Clinical Laboratory Operations, Technical...

  • Manager Manufacturing Quality Operations, RTP, NC

    3 weeks ago

    Raleigh-Durham, United States GRAIL Full time

    This position is a leader within the Quality Operations organization, responsible for establishing, implementing, maintaining, and improving the quality operations elements of GRAIL’s quality management system. This position interacts with departments throughout the organization including but not limited to Quality, Clinical Laboratory Operations,...

  • Staff Associate Scientist

    6 days ago

    Raleigh, United States GRAIL, LLC Full time

    GRAIL is seeking a Staff Associate Scientist (SAS) for the MSAT Reagent QC group in RTP, NC. This position is to support Reagent QC testing and laboratory management in a GMP laboratory setting. The Reagent QC laboratory utilizes several QC methods including NextGen Sequencing, physical property and quantitative methods to QC reagents, all of which the SAS...

  • Associate Director, Manufacturing Technical Operations

    7 days ago

    Raleigh, United States Biogen Full time

    Associate Director, Manufacturing Technical Operations Full-time Region: US Department: Manufacturing About This Role: This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Small Scale Manufacturing (SSM) and Flexible Volume Manufacturing (FVM) factories at out RTP Bio Site. This position will...

  • Manufacturing Engineer

    3 weeks ago

    Raleigh, United States Alkegen Full time

    Manufacturing Engineer - 1st Shift - Yadkinville NC page is loaded Manufacturing Engineer - 1st Shift - Yadkinville NC Apply locations Yadkinville, NC posted on Posted 30+ Days Ago job requisition id R4041 Job Requirements A hands-on engineer to provide technical assistance and support to Operations, Quality, Design Engineering and Maintenance, with a goal...

  • Quality Engineer

    7 days ago

    Raleigh, United States Accu-Fab Manufacturing Full time

    TITLE: QUALITY ENGINEERROLE LOCATION: Raleigh, NCREPORTS TO: Quality ManagerABOUT ACCU-FABAccu-Fab is a leading precision metal fabrication manufacturing business specializing in producing high-quality metal components and assemblies for various industries. Our state-of-the-art facility, advanced technologies, and skilled workforce enable us to meet our...

  • Quality Engineer

    6 days ago

    Raleigh, United States Accu-Fab Manufacturing Full time

    TITLE: QUALITY ENGINEERROLE LOCATION: Raleigh, NCREPORTS TO: Quality ManagerABOUT ACCU-FABAccu-Fab is a leading precision metal fabrication manufacturing business specializing in producing high-quality metal components and assemblies for various industries. Our state-of-the-art facility, advanced technologies, and skilled workforce enable us to meet our...

  • Lecturer, Operations and Supply Chain Management

    19 hours ago

    Raleigh, United States North Carolina State University Full time

    Posting Number PG193098EPInternal Recruitment NoWorking Title Lecturer, Operations and Supply Chain ManagementAnticipated Hiring Range Commensurate with education and experience.Work Schedule Varies based on the course schedule.Job Location Raleigh, NCDepartment Business ManagementAbout the DepartmentThe Department of Business Management in the Poole College...

  • Lecturer, Operations and Supply Chain Management

    7 hours ago

    Raleigh, North Carolina, United States North Carolina State University Full time

    Posting Number PG193098EPInternal Recruitment NoWorking Title Lecturer, Operations and Supply Chain ManagementAnticipated Hiring Range Commensurate with education and experience.Work Schedule Varies based on the course schedule.Job Location Raleigh, NCDepartment Business ManagementAbout the DepartmentThe Department of Business Management in the Poole College...

  • Manager, Manufacturing Operations

    4 weeks ago

    Raleigh, United States Evote Full time

    The focus of this job is to guide the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will be responsible for supervising and overseeing Day/Swing/Night shifts and to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in...

  • Operations Manager

    1 month ago

    Raleigh, United States Oak City Columns Full time

    Oak City Columns is a family-owned millwork manufacturing business that has been servicing the construction industry in NC, SC and VA for over 20 years. We primarily manufacture exterior millwork products for both residential and commercial projects and take pride in providing a consistent balance between product quality, customization and meeting customer...

  • Operations Manager

    1 month ago

    Raleigh, United States Oak City Columns Full time

    Oak City Columns is a family-owned millwork manufacturing business that has been servicing the construction industry in NC, SC and VA for over 20 years. We primarily manufacture exterior millwork products for both residential and commercial projects and take pride in providing a consistent balance between product quality, customization and meeting customer...

  • Operations Manager

    1 month ago

    Raleigh, United States Oak City Columns Full time

    Oak City Columns is a family-owned millwork manufacturing business that has been servicing the construction industry in NC, SC and VA for over 20 years. We primarily manufacture exterior millwork products for both residential and commercial projects and take pride in providing a consistent balance between product quality, customization and meeting customer...

  • Staff Product Manager, Lab Software

    6 days ago

    Raleigh, United States GRAIL, LLC Full time

    GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and...

  • Staff Associate Scientist

    7 days ago

    Raleigh, North Carolina, United States GRAIL, LLC Full time

    GRAIL is seeking a Staff Associate Scientist (SAS) for the MSAT Reagent QC group in RTP, NC. This position is to support Reagent QC testing and laboratory management in a GMP laboratory setting. The Reagent QC laboratory utilizes several QC methods including NextGen Sequencing, physical property and quantitative methods to QC reagents, all of which the SAS...

  • Quality Assurance Manager

    2 weeks ago

    Raleigh, United States Accentuate Staffing Full time

    Accentuate Staffing is seeking a Quality Assurance Manager to join a leading manufacturing company in Raleigh, NC. Responsibilities:Develop and implement programs for continuous improvement and attainment of quality targets.Support New Product Introduction process using advanced quality planning tools.Manage customer issue response system to ensure legal...

  • Quality Assurance Manager

    2 weeks ago

    Raleigh, United States Accentuate Staffing Full time

    Accentuate Staffing is seeking a Quality Assurance Manager to join a leading manufacturing company in Raleigh, NC. Responsibilities:Develop and implement programs for continuous improvement and attainment of quality targets.Support New Product Introduction process using advanced quality planning tools.Manage customer issue response system to ensure legal...

  • Manufacturing Engineering Manager

    6 days ago

    Raleigh, United States Columbus McKinnon Full time

    Location: Wadesboro, NC ( relocation package available) Position Overview: Directs and coordinates Manufacturing Engineering, Industrial Engineering, and Programming activities in support of plant operations by performing the following duties personally or through subordinates. Essential Duties and Responsibilities: Manages all aspects of plant manufacturing...

  • Quality MFG Investigations Writer

    6 days ago

    Raleigh, United States Randstad USA Full time

    Quality Manufacturing Investigations Technical WriterONSITE Monday-Friday, at RTP Manufacturing facilitySite-based role supporting biologics manufacturing--looking for a highly detailed and focused individual who demonstrates a beginning to intermediate level of technical process knowledge, technical writing ability, and subject matter expertise with...

  • Controls Design Engineering Manager

    5 days ago

    Raleigh, United States Southern Company Full time

    Job DescriptionDescriptionPowerSecure is searching for a Controls Design Engineering Manager. The Controls Design Engineering Manager are to be responsible for the health and welfare of the Controls Design Engineering team as well as management and adherence of the templates and standardization of Controls Designs for our Microgrid Products (Switchgear,...