Responsibilities: Responsible for all quality systems in scope from Global Process Function/Operational process standpoint. Report to Director of Quality Systems & Compliance. Responsible for initial implementation & validation support, periodic review & operational support to maintain systems in validated state.
Requirements: Bachelor's in Pharmaceutical Science, Biomedical Engineering, or related field & 7 years GXP regulated experience. Experience must include 7 years quality control/systems/assurance or research at commercial/clinical pharma/healthcare facility. Experience must include 4 years each of following: US FDA, European regulatory requirements, & ICH Guidelines; GAMP; experience with cloud-based SaaS Quality Systems; & implementing & maintaining cloud-based Quality Systems. Experience may be gained concurrently.
Salary: $180,000 - $185,000/year
Send resume via email to [email protected] or mail to Alkermes Inc., c/o Shawna Weidman, 900 Winter Street, Waltham, MA 02451-1420. Please reference job title (Quality Systems Manager).
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