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Director of QA - Biologics, Development & External in Waltham, MA



$200K - $250K*


Quality Management


11 - 15 years

Job Description

Director, Quality Assurance (Biologics, Development & External)

The Development & External Quality function represents the Alkermes quality organization in the day to day support and oversight of technical transfer, validation, GMP production and operations at contract manufacturing and packaging including storage and distribution for all clinical and commercial Alkermes products.

In addition, the Development & External Quality function is also responsible for:

  • The Alkermes Vendor Qualification program
  • Design Control for Drug — Device Combination Products, including PMSR
  • QA oversight and support of GMP Phase 1 production for both small and large molecule drug substance at the Alkermes Waltham MA facility
  • QA support and oversight for Analytical Development (Global)

The Development & External Quality Function t

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Valid through: 2020-4-9

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* Ladders Estimates