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 #LI-RS1 #LI-Onsite