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    Manufacturing Technical Services Manager - Providence, United States - Vertex Pharmaceuticals

    Vertex Pharmaceuticals
    Vertex Pharmaceuticals Providence, United States

    3 weeks ago

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    Description
    Job Description

    JOB DESCRPTION:


    Vertex Cell and Genetic Therapies (VCGT) is designed to accelerate our progress in bringing multiple new transformative medicines to patients in need.

    We are seeking an outstanding Manager, Manufacturing Technical Operations (MTO) to join our fast-paced and growing team.

    The MTO Manager will be a pivotal for maintaining quality event management across VCGT with focus in the following services:
    Deviations, Corrective and Preventive Actions, Risk Assessment, and Quality Event Metrics. The MTO Manager is an onsite role and will be based in Providence at the device manufacturing site. This role will require support across all VCGT locations with up to 25% regional travel to Boston locations. This role reports to Technical Operations Senior Manager, or designee.

    KEY RESPONSIBILITIES:

    • Lead, write, and review deviations and investigations for VCGT CMC including Manufacturing, Quality Control, Facilities, Supply Chain, and Material Management.
    • Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments.
    • Own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment) records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
    • Lead cross functional meetings and regularly update stakeholders on the status of ongoing investigations, ensuring transparent communication and timely resolution.
    • Act as site liaison to support the MTO Event Investigations team in development and improvements of MTO best practices.
    • Manage the development and distribution of Quality Event metrics to align with strategic objectives and decisions.
    • Lead cross function event investigations to determine root cause.
    • Apply GMP concepts and internally aligned interpretations of regulatory guidance as well as Vertex policy and procedure to ensure consistent and compliant practices across VCGT.
    • Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.
    • Demonstrate Vertex shared behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
    • Other duties and projects as assigned to meet departmental requirements.

    MINIMUM QUALIFICATIONS:

    • BS in Science or Engineering (or equivalent work experience)
    • 5+ years of progressive experience in biopharmaceutical development and manufacturing.
    • 2+ years of experience mentoring and managing staff.
    • Working knowledge of regulatory requirements, guidelines, and standards that govern cell and gene therapy GMP manufacture.
    • Understanding of science and technology of GMP manufacturing environment
    • Understanding of the science and technology of cell and gene therapies.
    • Excellent planning and organizational skills, balancing production, development, and continuous improvement needs.
    • Excel in interpersonal relations, showcasing the ability to lead through influence and effectively lead high-performing teams.
    • Experienced with technical writing and performing event investigations in a GMP-compliant environment.
    • Excellent verbal and written communication skills.
    #LI-onsite #LI-SV1
    Company Information
    Vertex is a global biotechnology company that invests in scientific innovation.

    Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

    Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
    Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at

    #J-18808-Ljbffr
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