Senior Associate Quality Assurance - Global Supply Quality

Let s do this. Let s change the world. In this vital role you will be responsible for the Quality oversight of Amgen s alliance partnerships and external supply portfolio management. This position is responsible for being an integral quality member of the Amgen cross-functional External Supply and Business Development teams that includes but is not limited to Amgen Contract & Development Manufacturing, Process Development, Supply Chain, and Business Development.

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 key collaborators 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.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master s degree and 1 to 3 years of experience in related fields OR

• Bachelor s degree and 3 to 5 years of experience in related fields OR

• Diploma and 7 to 9 years of 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 attitude 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