About this Sr Assoc QA - Global Supply Quality role at Amgen
Career Category
QualityJob Description
Description
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
We are seeking a highly motivated individual for our Global Supply Quality (GSQ) team. This is an incredibly exciting opportunity to join a team of quality professionals.
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Live
What you will do
The Sr. Associate QA position is 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.
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
