Senior Quality Assurance Associate II

Responsibilities:

• 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

Skills / Qualifications

• 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

Education

• Bachelor’s degree in a scientific discipline or related field