Senior Quality Assurance Associate II at Alkermes

About The Role

Primary interface with contract manufacturing organizations including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs. Oversight responsibilities include review of batch documentation, deviations, investigations, and change controls
Facilitate and interact with QP for review and release process
Maintenance and enhancement of quality systems to ensure conformance to Alkermes quality practices and international regulatory compliance requirements
Represent department on cross site projects
Monitor quality indicators highlighting trends and risks
Independently lead and/or support investigations into variances and quality issues and able to assure that proper changes are made to guarantee continued and consistent product quality
Proactively promote GMPs
Provide quality assurance representation, guidance, leadership, and direction to product development teams for two or more different operations which include; API/drug substance, drug product and labeling/packaging operations
Identify and evaluate quality, technical and product development issues
Provide guidance/mentoring to QA Associates and cross functionally and provide performance feedback to CMO as appropriate
Review of regulatory documentation and submissions

6+ years of experience in a pharmaceutical quality function
Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
QA Experience in pharmaceutical product development and expectations for early phase clinical trials
Broad quality experience, preferably including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, process validation.
Strong ability to troubleshoot and problem solve
Demonstrated proficiency in use of risk assessment tools
Ability to effectively plan, organize and prioritize work