Senior Associate Quality Assurance - Global Supply Quality

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for the Quality oversight of Amgens 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.




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 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.

What we expect of you

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

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