Amgen External Supply Quality QA Manager in Dublin, Ireland
Quality and Compliance oversight of lower risk External sites. Ensure External site activities are in alignment with applicable product CTA /Marketing Application.
Serve as the main Quality point of contact related to Amgen product at External site. Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements. Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses. Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site. Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site. Author and drive actionable site inspection readiness plans. Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site. Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required. Identify and mitigate risk at the External site . Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews. Escalate risks or roadblocks to management. Drive timely decision making using DAI principles. Drive continuous improvements and Amgen first mindset. Perform tactical batch disposition activities in support of lot release Authority. Decision to release or reject batches. Decision to approve or reject an External site change implementation / deviation. Advise on External site status. Advise on External site Inspection readiness . Identify opportunities and issues, then determine when escalation is necessary
Basic Qualifications :
Doctorate degree OR Master’s degree & 2years of directly related experience OR Bachelor’s degree & 4years of directly related experience ORAssociate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience.
Preferred Qualifica tions :
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry. Bachelor’s Degree in a Science Field. cGMP Experience. Ability to oversee multiple projects simultaneously. Able to successfully manage workload to timelines. Familiarity with basic project management tools. Ability to negotiate a position after taking feedback from multiple sources. Demonstrated ability to consistently deliver on-time, and high-quality results. Ability to operate in a matrixed or team environment. Ability to manage diverse relationships. Ability to lead and manage cross-functional teams. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Ability to travel +/-10% of time to domestic and international Amgen/External sites.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.