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    Compliance Manager, Quality Assurance - Minneapolis, United States - PAREXEL

    PAREXEL
    PAREXEL Minneapolis, United States

    1 week ago

    PAREXEL background
    Description
    Additional Job Description

    Home Based, US

    The Quality Assurance (QA) Compliance Manager has a high level of knowledge and experience of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes to conduct audits and provide expert advice to internal and external clients.

    To effectively lead, matrix manages, develop, and implement assigned projects.

    To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.

    Expertise in Investigator Site Audits and Trial Master File Audits is mandatory, preferably with CRO experience.
    Key Accountabilities

    :

    Management/coordination/oversight

    of QA compliance GxP activities in a specific geographical and/or

    functional/specialist

    area, as assigned by QA Sen Management
    Work closely with Regulatory authorities and Sponsors. Support regulatory inspections & sponsor audits as needed
    Act as QA Lead for billable audit programs or a client account for which QA representation is needed
    Maintain knowledge of project /audit status in assigned areas
    Support Third Party Supplier activities as needed
    Process Improvements
    Provide Trainings
    Build and maintain relationships
    Perform other quality related task or projects as assigned.
    Travel internationally on assignments as required. Travel time could be up to approx. 60%.
    Skills:

    Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client's business
    Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
    Experience with Microsoft based applications and ability to learn internal computer systems
    Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
    Ability to work flexibly and adjust to changing priorities and unforeseen events
    Diplomatically address sensitive issues confidentially and professionally
    Excellent knowledge of, and working experience with, relevant national / international regulations
    Lead team / project to successful conclusion
    Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups
    Work professionally with highly confidential information
    Work independently and consistently in a fast-paced environment
    Knowledge and Experience

    :

    Preferred 5-8 years' experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management,

    safety/pharmacovigilance,

    pharmacy, laboratory, or other relevant area such as technology, third party supplier management, including profound applicable GxP auditing.
    Education:

    Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
    Master's degree in a science, technology or industry related discipline, preferred

    #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer.


    Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    #J-18808-Ljbffr
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