• Global Project Quality Senior Associate

    ThermoFisher Scientific (Juneau, AK)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Office

    Job Description

    We are currently seeking a remote-based Associate focused on Quality Assurance for Global Projects to join our team. As the sole supplier responsible for delivering all AxMPs and Commercial IMPs for a global project, you will have the opportunity to collaborate with key customers and make a significant impact on approximately 150 Clinical Trials across approximately 70 countries.

     

    In this position, you will have a vital role in ensuring the successful implementation of our global sourcing projects. Your contributions will support our mission to enhance global health, cleanliness, and safety.

     

    + Collaborate closely with the Global Project QA Manager and extended team daily to assist with sourcing strategy for the project, considering both local and global regulatory duties.

    + Serve as the coordinator for strategic and key operational client-related QA communication across multiple sites.

    + Ensure release documentation (certificates, release documentation) is prepared, verified and shared with applicable parties promptly to ensure project timelines are met.

    + Ensure all project documentation is current and accessible to key partners

    + Support situations involving market shortages and country-related challenges, ensuring quick resolution.

    + Support the timely handling of complaints or recalls on multiple sites to ensure client expectations are met.

    + Report or capture important metrics as required.

    + Collaborate with the CRG for AxMP labeling.

    + Ensure key internal team is advised of significant customer relationship issues, needs or developments.

    + Other duties, as assigned to meet business needs.

    Keys to Success:

    To excel in this role, you will need:

    + Broad knowledge of GMPs (e.g.: EU, FDA, APJ)

    + QA/regulatory compliance experience in the pharmaceutical, chemical, medical device, or biotech industry.

    + Knowledge of commercial medication sourcing and global labeling requirements for AxMPs and IMPs.

    + Good understanding of global customs requirements and RA submission strategies.

    + Demonstrated ability to lead and work collaboratively with diverse groups.

    + Excellent problem-solving and prioritization abilities to overcome obstacles and achieve key outcomes.

    + The capability to handle competing priorities and adapt to constantly evolving customer requirements.

    Education

    + Bachelor's Degree, preferably in a scientific field.

    Experience

    + As mentioned above

    Knowledge, Skills, Abilities

    + Good knowledge of global supply chain strategies.

    + Good decision-making and negotiation skills.

    + Ability to evaluate potential risks and recommend process improvements.

    + Excellent written and oral communication skills.

    + Ability to prioritize workload and meet customer needs.

     

    Remote Office Work environment, Monday-Friday, 8:00 AM- 5:00 PM (additional hours as necessary)

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.