Global External Quality, Technical Specialist

Biogen Idec
Full time Full day
Cambridge, MA

Company Description


Job Description


The role also includes preparation and extraction of reports, monitoring of GEQ KPIs, as well as support in projects and process improvements impacting the Cambridge and Baar sites. The role additionally provides support during product market launch activities (project management support, GCCs etc.) and projects from a systems perspective (e. g support in continuous improvement initiatives, global processes alignment, regulatory intelligence actions implementation for internal and external processes etc.).



  • Support the Global External Quality organization as required in the initiation and follow up of deviations, CAPAs, and change controls (internal and external including Market launch activities), as well as the Authorization to Manufacture and product Transport approvals under the responsibility of Global External Quality.

  • Support projects, and global processes alignment (internal and external) as well as continuous improvement initiatives, regulatory intelligence actions monitoring and implementation.

  • Support Quality CMO leads, Quality Engineering, and Quality Systems & Compliance groups with data collection and the preparation of Quality Management Reviews (global, Baar & CAM sites), CMO performance assessments, CMO risk forum, Annual Product reviews (including- running reports in the IT Quality Systems, perform trend analysis, etc.)

  • Provide support in the quality oversight for IT Quality systems enhancements and business processes as needed. Support improvements and roll out for those systems to the end users.

  • General Global External Quality department support – Documentation: Responsible for processing workflows in the documentation management system (quality agreements, CMO performance evaluations, annual product review documentation, master batch records management, PRCD updates etc.)

  • Provide onboarding activity assistance to ensure that the new starters within the Global External Quality organization have all appropriate training, tool & system access and resources in place to execute their onboarding plan in timely manner. Provide resource allocation analysis support as required.


Qualifications



  • Knowledge of cGMP requirements.

  • Experience in IT quality systems qualification or project management is a plus

  • Education: BA/BS in Life Sciences (Pharmacy, Chemistry, Biology, Biochemistry strongly preferred) with 4+ years of relevant industry experience, or MA/MS in Life Sciences (Pharmacy, Chemistry, Biology, Biochemistry strongly preferred) with 2+ years of relevant industry experience.


Additional Information


The person in this function provides Global External Quality technical and administrative support in relation to daily activities. He/she provides support in GEQ Quality Systems, Program Management, CMO management, and Release activities for all commercial and clinical products (incl. external and internal Deviations, CAPAs and Change Controls, as well as administrative transactions in the IT Quality systems that are under the Quality Oversight of Global External Quality organization).

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