Senior Associate Quality Assurance - Global Supply Quality

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.

Basic Qualifications:

• Masters degree and 1 to 3 years of experience in related fields OR
• Bachelors 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 practice's 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