Sr Assoc QA - Global Supply Quality

Responsibilities: 

Working independently, the individual will be responsible for, but not limited to the following: 

• Perform QA Contact role for partners to ensure adherence to quality agreements, identifying performance improvement opportunities 

• Perform Partner/Client assessments for Change Control and Deviation records  

• Perform Quality tasks in support of Partnership Alliance Quality in accordance with Quality Agreements (i.e. document revisions, document redactions, support partner audits) 

• May perform QA responsibilities associated with Portfolio Strategy Execution, such as supporting Due Diligence activities 

• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP. 

• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP) and other applicable regulations 

• Collaborate with external suppliers and partners  

• Understand and incorporate risk management strategy into the overall external supply lifecycle  

• Support in tactical activities related to internal/external audits and inspections  

• Take part in operational improvement initiatives, programs, and projects  

• Develop solutions that are thorough, practical, and consistent with functional objectives 

• Ownership of business metrics, performance assessments, and other key documents to inform the health of external supplier and partner relationships. 

• Work under minimal supervision in line with Amgen Values and Leadership Attributes. 

Win 

What we expect of you: 

Education and Experiences: 

• We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: 

• Bachelor’s degree in science or engineering and 2+ years of professional experience in related fields. 

• Understanding of GMP/GDP requirements. 

• Familiarity with raw material compendial testing 

• Experience overseeing quality of suppliers or external parties 

• Strong technical writing skills. 

• Strong experience in Alliance Management 

Preferred Qualifications 

• Strong continuous improvement mindset and lean practices experience. 

• Understanding of end-to-end supply chain business processes. 

• Experience in project management across multiple departments and geographies. 

• Quick process understanding, insight and visualizing. 

• Strong analytical and problem-solving skills. 

• Independent self-starter, able to work autonomously, under pressure and in teams. 

• GMP/GDP knowledge and understanding of pharmaceutical regulations. 

• Energetic, detail oriented, highly motivated with a “can do” outlook. 

• Change management skills. 

• Ability to communicate across all levels of the organization. 

• Effective written and verbal communication skills. 

• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. 

• Ability to multi-task and prioritize