Jobs
>
Boston

    Associate Director, Quality Assurance - Boston, United States - Rhythm Pharmaceuticals

    Rhythm Pharmaceuticals
    Rhythm Pharmaceuticals Boston, United States

    2 weeks ago

    Default job background
    Full time
    Description

    Company Overview
    Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
    Opportunity Overview
    Rhythm is looking for an Associate Director QA to play a leadership role in strengthening Rhythm's Global Quality Management System being the subject matter expert for the learning and training management, documentation life cycle, Rhythm's validated electronic system that houses all of Rhythm's GxP records. The Associate Director QA will lead the Quality and Compliance governance and ensures that Rhythm and all its affiliates worldwide are working with a well connected and streamlined quality management systems. He/she works and liaises with the global team in establishing key metrices to define areas for continuous improvement and maintain a steadfast growth in Rhythm's quality culture and compliance stance.
    The Associate Director QA will report to the Head of QA GMP/GDP, based in The Netherlands, while working across global functions at Rhythm.
    Responsibilities and Duties

    • Manage Rhythm's initial and continuous training and personnel qualification systems and processes
    • Establish key Quality Performance metrices to identify areas for improvements in Rhythm's Quality Management System (QMS) and report the state of Good Practice (GxP) compliance to management.
    • Establish and maintain GxP procedures, policies, forms, and other controlled documents in Rhythm's Quality Docs system
    • Lead and Manage the Electronic Document Management System (EDMS) for all GxP controlled documentation.
    • Be the primary contact for the Learning Management System (Absorb LMS) for all GxP related trainings.
    • Oversee GMP/GDP/GxP internal and external audit program; develop a routine audit plan and communicate and follow up its status with relevant stakeholders.
    • Point Person for Rhythm Product Complaint Management Program and ensure proper reconciliation against other relevant product safety and quality reporting systems
    • Manage the electronic QMS (Veeva Vault) for Quality Events, Change Management, and Vendor Management modules.
    • As needed, support Information Technology initiatives ensuring a compliant roll out and post-deployment maintenance of critical GxP IT systems
    • Assist preparations for corporate and health authority inspection-readiness programs
    • Serve as a subject matter expert (SME) for areas of responsibility during regulatory inspections, and directly manage inspection readiness activities.
    • Support Quality Risk Management programs by overseeing global risk registers and risk mitigation initiatives within the Technical Operations team.


    Qualifications and Skills

    • Bachelor's degree in pharmaceutical life sciences
    • A minimum of 8 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge and expertise
    • Working knowledge of current Good Manufacturing, Distribution, Clinical and Pharmacovigilance Practices, US and European Guidelines as related to the Pharmaceutical Industry
    • Direct experience managing GxP systems (LMS, Veeva Vault)
    • Experience in Audits, Risk Mitigation and Project management
    • Experience in managing and hosting competent authority inspections
    • Ability to work with highly diverse team in a remote working environment


    This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
    More about Rhythm
    Our lead asset, IMCIVREE (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.
    We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm's headquarters is in Boston, MA.

  • DPS Group TSO

    Quality Assurance Specialist

    3 weeks ago

    DPS Group TSO Boston, United States

    **Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...

  • DPS Group

    Quality Assurance Specialist

    3 weeks ago

    DPS Group Boston, United States

    ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...

  • Elegant Enterprise Wide Solutions, Inc

    Quality Assurance Lead

    3 days ago

    Elegant Enterprise Wide Solutions, Inc Boston, United States

    **Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...

  • Elegant Enterprise Wide Solutions, Inc

    Quality Assurance Lead

    5 days ago

    Elegant Enterprise Wide Solutions, Inc Boston, United States

    **Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...

  • RADcube

    Quality Assurance Manager

    1 day ago

    RADcube Boston, United States

    **Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...

  • Deephealth

    Quality Assurance Specialist

    1 week ago

    Deephealth Somerville, United States

    **Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...

  • Global Atlantic Financial Group Opportunities

    Quality Assurance Testing Lead

    1 week ago

    Global Atlantic Financial Group Opportunities Boston, United States

    **COMPANY OVERVIEW** · Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment firm that offers alternative ass ...

  • NavitsPartners

    Quality Assurance Test Manager

    3 weeks ago

    NavitsPartners Cambridge, United States

    **Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...

  • Brigham & Women's Hospital(BWH)

    Ct Quality Assurance Specialist

    4 days ago

    Brigham & Women's Hospital(BWH) Boston, United States

    **CT Quality Assurance Specialist** · 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, and eval ...

  • Pine Street Inn

    Training and Quality Assurance Manager

    15 hours ago

    Pine Street Inn Boston, United States

    **SCHEDULE**:40 hours, Monday - Friday, 8:00 a.m. - 4:30 p.m. (some evenings and weekends as needed) · **LOCATION**:Remote (with Travel) · **The Electronic Health Record Specialist is a non-essential position in the event of emergency or weather and will work 100% remote at this ...

  • Global Pharma

    Quality Assurance

    1 week ago

    Global Pharma Woburn, United States

    **Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...

  • Commonwealth Care Alliance

    Quality Assurance Reviewer Associate I

    2 weeks ago

    Commonwealth Care Alliance Boston, United States

    **Why This Role is Important to Us**: · **Position Summary**: · Reporting to the VP Quality & Controls Assurance, the incumbent is responsible for independent quality reviews of medical claims, and evaluating Call Center activities for compliance with policies and Standard Operat ...

  • Catalent

    Quality Assurance Specialist I

    3 days ago

    Catalent Chelsea, United States

    **We're hiring for a rotating night shift Quality Assurance Specialist I to provide QA support for cGMP manufacturing activities, at our facility in the Boston area** · Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ...

  • Vedanta Biosciences

    Contract - Quality Assurance Specialist, Cmc

    2 weeks ago

    Vedanta Biosciences Cambridge, United States

    **Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...

  • Novalink Solutions LLC

    Fare Systems Quality Assurance Lead

    1 week ago

    Novalink Solutions LLC Boston, United States

    The Fare System Quality Assurance Lead – Fare Transformation will have overall responsibility for compliance demonstration, quality assurance, and defect resolution for the new MBTA fare system. They will lead test strategy, monitor vendor's progress towards demonstrating complia ...

  • Vertex Pharmaceuticals

    Manager, Audit and Inspection Quality Assurance

    2 days ago

    Vertex Pharmaceuticals Boston, United States

    Job Description · General Position Summary: · The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting i ...

  • Vertex Pharmaceuticals

    Commercial Gmp Quality Assurance Specialist

    1 week ago

    Vertex Pharmaceuticals Boston, United States

    **Job Description**: · **JOB DESCRIPTION**: · **KEY RESPONSIBILITIES**: · May include, but are not limited to, the following: · - Identifies and supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause a ...

  • Emerald Enterprises

    Project Manager Automotive in Quality Assurance

    3 days ago

    Emerald Enterprises Cambridge, MA, United States Freelance

    Are you looking to take the next step in your career? At Brunel, you have the opportunity to continuously develop yourself with renowned clients across industries. Take the decisive step in your career today and apply with us as a Project Manager for Automotive Quality and Produc ...

  • Boston University

    Quality Assurance Analyst Ii, Information Services

    3 days ago

    Boston University Boston, United States

    Position responsibilities: _ · - Formulate comprehensive Test Strategy and Test Plan documents, outlining the overarching strategy and approach. · - Facilitating effective coordination of testing activities between functional and technical teams. · - Develop comprehensive functio ...

  • State Street

    Quality Assurance

    1 week 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 ...