Jobs
>
Boston

    Director, GMP Quality Assurance - Boston, United States - Imbria Pharmaceuticals

    Imbria Pharmaceuticals
    Imbria Pharmaceuticals Boston, United States

    3 weeks ago

    Default job background
    Description

    Company Overview

    Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit .

    Position Overview

    The Director, GMP Quality Assurance will lead the GMP quality function by supporting and providing oversight of CMC activities, establish and manage GMP quality systems, and ensure GMP compliance. The candidate will be a hands-on and actively involved in executing GMP QA strategy, collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners. Note: This position requires the incumbent to reside in the Boston area.

    Responsibilities

    • Develop, implement, and maintain GMP quality management systems, policies, and SOPs
    • Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of clinical materials
    • Conduct review of MBRs and EBRs and perform final product disposition
    • Perform quality management review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records
    • Review and approve product specifications, test methods, qualification/validation protocols and reports
    • Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.
    • Monitor, track, and trend GMP quality systems and establish metrics
    • Manage GMP audit activities, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits
    • Manage investigational product complaints and are investigated to ensure compliance
    • Establish inspection readiness program
    • Manage GMP training and provide quality training as appropriate
    • Perform other duties as require

    Qualifications

    • Minimum Bachelor's degree in a relevant scientific discipline or equivalent
    • Minimum of 8 years of pharmaceutical industry experience in CMC/GMP QA
    • Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance
    • Experience working with CDMOs, vendor selection, and management
    • Proven ability to thrive and enable success in a cross-functional and collaborative environment
    • Strong communication and interpersonal skills (maintain positive relationship and open communication)
    • Ability to multi-task, shift priorities, and work in a fast-paced environment
    • Detail oriented and well organized
    • Team player, professional demeanor, enthusiastic, and self-motivated

    This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria

  • The Brookline Center for Community Mental Health

    Quality Assurance Manager

    1 week ago

    The Brookline Center for Community Mental Health Boston, United States

    QUALITY ASSURANCE MANAGER · If you're excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you We're looking for people who want to be part of a fast-paced and entrepreneurial te ...

  • Hunter Hamilton

    Quality Assurance Auditor

    5 days ago

    Hunter Hamilton Boston, United States Temp to Hire

    Quality Assurance Auditor · Location: Boston, MA (Remote) Position Type: Temp to Hire Reference ID: Salary: $ $21.00 Date Posted: Description: We have multiple openings for Quality Assurance Auditor to join our growing team · Our Quality Assurance Auditor's role is to assess t ...

  • Harba Solutions Inc.

    Director of Quality Assurance

    1 week ago

    Harba Solutions Inc. Cambridge, United States

    Responsibilities · Recruit, develop, and motivate staff to ensure effective departmental functions and maintain managerial and specialized skills. · Provide coaching and mentoring to staff, focusing on job performance and career development, including training, feedback, rewards, ...

  • Brigham and Women's Hospital

    CT Quality Assurance Specialist

    5 days ago

    Brigham and Women's Hospital Boston, United States Full time

    CT Quality Assurance Specialist Description Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, a ...

  • Imbria Pharmaceuticals

    Director, GCP Quality Assurance

    3 weeks ago

    Imbria Pharmaceuticals Boston, United States

    Company Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...

  • Motion Recruitment

    Senior Quality Assurance Engineer

    2 weeks ago

    Motion Recruitment Boston, United States Direct Hire/Full Desk

    Our Client, an E-Learning company focused on providing assessments and personalized instructional materials, are currently looking to bring aboard a Senior Quality Assurance Engineer to their team. As a QA Engineer here, you will be focused on driving their products/platform forw ...

  • Orbia

    Global Quality Assurance Manager

    3 weeks ago

    Orbia Boston, United States

    At Dura-Line, an Orbia business, we create solutions that better connect people and information across the globe. We are the leading manufacturer and distributor of telecommunications conduit, cable-in-conduit and other high-density polyethylene (HDPE) and connectivity infrastruc ...

  • State Street

    Quality Assurance

    2 weeks ago

    State Street Boston, United States OTHER

    Quality Assurance (State Street Bank and Trust Company; Boston, MA): Will serve the Company by testing software for advanced internal Client Server applications. Will test State Street's proprietary, industry-leading platforms by coordinating with development, writing test cases, ...

  • Collabera

    Quality Assurance Manager

    4 weeks ago

    Collabera Cambridge, United States

    Job DescriptionJob Description · Title:Quality Assurance Manager · Location: Cambridge, MA · Duration: 12+ months · Description: · 100% Onsite AMA · M-F (8am - 5:00 pm, flexible) · This role provides quality oversight with regards to the development and lifecycle managemen ...

  • Voyager Therapeutics, Inc.

    Quality Assurance Specialist

    1 week ago

    Voyager Therapeutics, Inc. Cambridge, United States

    The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Tria ...

  • Collabera

    Quality Assurance Manager

    3 weeks ago

    Collabera Cambridge, United States

    Job Description · Job DescriptionTitle: Quality Assurance Manager · Location: Cambridge, MA · Duration: 12+ months · Description: · 100% Onsite AMA · M-F (8am - 5:00 pm, flexible) · This role provides quality oversight with regards to the development and lifecycle management of t ...

  • State Street

    Quality Assurance

    2 weeks ago

    State Street Boston, United States OTHER

    Quality Assurance (State Street Bank and Trust Company; Boston, MA): Responsible for testing software for advanced internal proprietary, industry-leading client server platforms by coordinating with development, writing test cases, executing tests, contributing to building our au ...

  • Masis Professional Group

    Quality Assurance Manager

    2 days ago

    Masis Professional Group Somerville, United States

    Quality Assurance Manager Job Description:Masis Professional Group has an immediate need for a Quality Assurance Manager for a very well established and growing Manufacturing firm in the Somerville, Tennessee area on a full-time direct hire basis. Core responsibilities include ma ...

  • TalentBurst

    Quality Assurance Analyst

    3 weeks ago

    TalentBurst Chelsea, United States

    Quality Assurance Analys · Chelsea/ Boston, MA · 8 plus months · This individual will work on site (about 40% of time) and remotely (about 60% of time). The on-site location is split between 200 Arlington Street in Chelsea and 1 Ashburton Place in Boston.Client is seeking a mo ...

  • Rose International

    Quality Assurance Analyst

    3 weeks ago

    Rose International Chelsea, United States

    Date Posted: 05/10/2024 · Hiring Organization: Rose International · Position Number: 463845 · Job Title: Quality Assurance Analyst · Job Location: Chelsea, MA, USA, 02150 · Work Model: Hybrid · Employment Type: Temporary · Estimated Duration (In months): 9 · Min Hourly Rate($): 4 ...

  • Vericel Corporation

    Supervisor, Quality Assurance

    2 weeks ago

    Vericel Corporation Cambridge, United States

    Job Description · Job DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing QA professional looking to join and contribute to a commercial stage company with an establi ...

  • Lazarusai

    Quality Assurance

    2 weeks ago

    Lazarusai Cambridge, United States

    Lazarus AI creates dynamic, highly accurate machine learning APIs to solve the data extraction and data activation challenges of our customers. Our latest innovation, RikAI, is a large language model that extracts data from any document without training, regardless of type, forma ...

  • IK Hofmann

    Quality Assurance

    3 days ago

    IK Hofmann New Boston, MI, United States

    Quality Inspector- $19.75 per hour · We are looking for candidates to fill Quality Inspector positions for our automotive manufacturing client for their New Boston, MI location. This is a temp to hire position. · Conduct quality control at assembly lines through audits, inspect ...

  • Schreiber Foods

    Quality Assurance Team Advisor

    5 days ago

    Schreiber Foods Logan, United States Full time

    Job Category: Quality Job Family: Plant Quality Assurance Job Description: In the Quality Assurance Team Advisor (Supervisor) position, you will lead the efforts of a quality team. Duties include planning, organizing, training, coaching, and compliance with various customers, com ...

  • LanceSoft, Inc.

    Quality Assurance Technical Writer

    5 days ago

    LanceSoft, Inc. Cambridge, United States

    Description: · POSITION TITLE: Technical Writer · DURATION: 1 YEAR · Location: Cambridge, MA 02142 · ON SITE (flexibility to work 1 day from home) · Payrate: $40.62/an hr. · The technical writer position will require interaction with manufacturing personnel, manufacturing engine ...