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    Lab Manager - Oxford, Oxfordshire, United Kingdom - Moderna Therapeutics

    Moderna Therapeutics
    Moderna Therapeutics Oxford, Oxfordshire, United Kingdom

    2 weeks ago

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    Full time
    Description
    Senior Manager, Quality Strategies – Non-Clinical Quality page is loaded Senior Manager, Quality Strategies – Non-Clinical Quality
    Apply locations Oxford - England Clinical Development time type Full time posted on Posted Yesterday job requisition id R15529 The Role

    As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

    Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

    Our mission is to establish a leading-edge research, development, and manufacturing facility as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases.

    This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK.

    Manager, Quality Assurance (GLP/GCLP and CSV) at Moderna, you'll be at the forefront of ensuring quality and compliance within our dynamic and innovative environment.

    You'll be instrumental in overseeing Moderna Biomarker laboratory activities, ensuring the integrity and quality of bioanalytical analysis, and providing vital Quality support to validation activities and audits of computerized systems.

    Actively participating in strategic initiatives requiring GLP and CSV quality support.

    Developing and guiding administration programs to monitor and promote quality and performance operations related to CSV projects and studies.

    Planning, conducting, and reporting on internal, in-process, study, and process audits to ensure GCLP compliance.
    Leading internal and vendor computer system audits, managing audit CAPAs, and supporting regulatory inspections.
    Fostering a culture of quality within Moderna and its R&D efforts.
    Engaging with regulatory agencies and corporate partners during inspections and audits.
    Contributing to the continuous development of Moderna's quality culture.
    Taking initiative and displaying a sense of ownership over projects and outcomes.
    BS/BA, MS or PhD

    Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP (understanding of regulatory guidelines for other countries a plus).

    Bioanalytical technology, including but not limited to LIMS, PCR, plate reader, and mass spectroscopy proficiency is highly desired.
    Expertise with business office applications, word processing and spreadsheets.
    Demonstrated knowledge and/or prior experience in Quality Assurance.
    Ability to manage multiple projects in a fast-paced environment.
    Ability to make decisions that are guided by policies, procedures, and business plan; We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
    Quality healthcare and insurance benefits
    Lifestyle Spending Accounts to create your own pathway to well-being
    Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown

    By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

    Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

    We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.

    Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

    Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
    Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.

    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 Talent Acquisition Partner or contact the Accommodations team at .At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).

    We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

    To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

    Our Vision :

    To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

    Third Party Staffing Agencies

    For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.

    Reasonable Accommodation Notice
    Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.

    Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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